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Abstract of dissertation entitled

An evidence-based guideline of using massage therapy to reduce pain

and anxiety level in oncology patients

Submitted by

Tse Wing Chi

for the degree of Master of Nursing at the University of Hong Kong

in July 2016

Pain and anxiety are the most common physiological and psychological distress experienced

by oncology patients. Most of the physiological and psychological distresses of cancer are treated

with pharmacological methods only. The cancer distress is underestimated by the health care

professionals. One of the non-pharmacological methods, massage therapy, is used in relieving pain

and anxiety level of cancer patients. Several findings have reported the beneficial effects of

massage therapy in reducing pain and anxiety level in oncology patients. However, this application

has not been well developed and adopted by our current clinical settings.

The aim of this dissertation is to develop an evidence-based guideline of using massage

therapy to reduce pain and anxiety level in oncology patients. The objectives of this dissertation are

to evaluate current evidence on the effectiveness of using massage therapy to reduce pain and

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anxiety level in oncology patients, to assess the implementation potential including the

transferability and feasibility of using massage therapy, to develop an evidence-based guideline on

the implementation of massage therapy and to develop an implementation plan and evaluation plan

for massage therapy on cancer patients in local oncology ward.

A systematic review has been performed to investigate if massage therapy can be useful in relieving

cancer pain and anxiety. Using two electronic databases, PubMed and CINAHL plus (EBSCOhost)

via the University of Hong Kong Library database, a search was conducted to identify eligible

studies. Quality of the eligible studies were assessed and criticized by the use of appraisal checklist

of Scottish Intercollegiate Guidelines Network (SIGN) (2015). The evidences are then summarized

and synthesized. An evidence-based practice guideline of using massage therapy to reduce pain and

anxiety level in oncology patients is made based on the evidence retrieved from the selected

reviews. The implementation potential of the evidence-based guideline is assessed according to the

target setting, target audience, transferability of the findings, feasibility and cost-benefit ratio. It is

highly transferable and feasible for the guideline to be implemented in the target setting for the

target audience. After the evidence-based guideline has been developed, an implementation plan

including the communication plan with stakeholders and formulation of a team is formulated. A

pilot study is required and finally an evaluation plan is made including the evaluation on the clinical

outcomes, health care providers outcomes and system outcomes. It is expected that the proposed

massage therapy innovation would be considered an effective measure in reducing pain and anxiety

level in oncology patients.

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An evidence-based guideline of using massage therapy to reduce pain

and anxiety level in oncology patients

by

Tse Wing Chi

Bachelor of Nursing, Registered Nurse

A dissertation submitted in partial fulfillment of the requirements for the degree of

Master of Nursing

at The University of Hong Kong

July 2016

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Declaration

I declare that this dissertation represents my own work, except where due acknowledgement

is made, and that it has not been previously included in a thesis, dissertation or report submitted to

this University or to any other institution for a degree, diploma or other qualifications.

Signed: _____________________________________

Tse Wing Chi

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Acknowledgements

I would like to express my sincere gratitude to my supervisor Dr Patsy Chau, who provided

guidance and inspirations on this dissertation. Her encouragement and support throughout these two

years has enabled me to complete this dissertation.

Finally, I would like to thank my family, friends and colleagues for their constant love and

support to complete this master programme.

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Table of Contents

Declaration……………………………………………………………….………………………......4

Acknowledgements…………………………………………………………………………………..5

Table of contents……………………………………………………………………………………..6

Chapter 1: Introduction

1.1 Background……………………………………………………………………………….7

1.2 Affirming the Need……………………………………………….………………………9

1.3 Objectives and Significance ……………...…………………….……………………....12

Chapter 2: Critical Appraisal

2.1 Search and Appraisal Strategies………………………………..……………………….13

2.2 Results………………………………………………………….……………………….15

2.3 Summary and Synthesis………………………………..…………………………….....17

Chapter 3: Translation and Application

3.1 Implementation Potential …………………………………………………………….....20

3.2 Evidence-based Practice Guideline …………………………….…………..…………..28

Chapter 4: Implementation Plan

4.1 Communication Plan…………………………………………..…………..…………........29

4.2 Pilot Study…………………………………………………….…………..………….........33

4.3 Evaluation Plan ………………………………………………..…………..…………........35

4.4 Basis for Implementation…………………………………………………..………….......38

Chapter 5: Conclusion…………………………………………………. …………..…………........39

Appendix A: Summary of Database Search Strategy and Result……....…………..………….........40

Appendix B: PRISMA Flow Diagram………………………………….…………...………….......41

Appendix C: Table of Evidence ………………………………………..…………..…………........42

Appendix D: SIGN Checklists ………………………………………………………...…………...44

Appendix E: Timeline for Implementation of the Massage Program…...……………..…………...54

Appendix F: Estimated Number of Massage Therapists Recruited………..…………...…………..55

Appendix G: Estimated Material Costs for the Innovation ……………....…………....……...……56

Appendix H: Cost/Benefit Ratio of Implementing the Innovation……........…………..………......57

Appendix I: Level of Evidence SIGN Grading System…………........…...………...………….......58

Appendix J: SIGN grading system: Grade of Recommendation……….……..……..……………...59

Appendix K: Evidence-based Practice Guideline …………………….………………………........60

Appendix L: Assessment Form for Massage Treatment………………………………...…..……...66

Appendix M: Patient’s Questionnaire on Satisfaction towards Massage Therapy…….…………...67

Appendix N: Staff Self-reported Questionnaire on the use of Massage Innovation…………….....68

References ……………………………………………………………...…………………………..69

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Chapter 1: Introduction

Pain and anxiety are the most common physiological and psychological distress experienced by

oncology patients. Most of the physiological and psychological distresses of cancer are treated with

pharmacological methods only. The cancer distress is underestimated by the health care

professionals as they rely on pharmacological method and think it could help in relieving most of

the cancer distresses. One of the non-pharmacological methods, massage therapy, is used in

relieving pain and anxiety level of cancer patients. In this chapter, the significance of implementing

massage therapy for oncology patients to reduce their pain and anxiety level would be illustrated.

1.1 Background

According to the World Health Organization (2015), cancer is defined as the rapid creation of

abnormal cells which grow beyond their normal boundaries, and maybe invading neighbouring

parts of the body and also spreading to other organs. The spreading process is called metastasis.

Cancer causes a lot of deaths among the world. In 2012, there are 14 million new cancer cases and

8.2 million cancer related deaths. In Hong Kong, according to the Centre for Health Protection

(2014), malignant neoplasms is found to be the first leading causes of death in 2014, compared to

other causes such as pneumonia and coronary heart disease. The morality rate of cancer is 190.6 per

100,000 populations, which accounts for 30.2% of death in Hong Kong in 2014. From 2001 to

2014, there has been an increasing number of deaths for cancer every year from 169.9 per 100000

population in 2001 to 190.6 per 100000 population in 2014. According to the Hospital Authority

(2014), cancer remains a burden to the Hong Kong society and the new cancer cases has risen at an

annual rate of 2.5% on average but the population just grew at an annual rate of 0.6% only from

2002-2012. It is found that the rise in number of oncology patients and deaths is due to the growing

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population and the ageing society. If the current trends continue, the number of new cases for

cancer patients would continue to increase.

Cancer patients suffer from both physical and psychosocial distress which is a significant issue in

our society. Cancer pain is one of the most important symptoms for cancer patients which cause a

lot of distress to them. It causes not only a lot of distress to the oncology patients but also to their

families (Saturno et al, 2014). More than one-third oncology patients have given a rate to their pain

level to be moderate or severe (van den Beuken-van Everdingen et al., 2007). However, the World

Health Organization (2015) estimated that 80% or more patients in the world are inadequately

treated even if they got moderate to severe pain. Nowadays, the cancer pain is usually treated

pharmacologically. According to Kim, Ahn and Minerva (2015), 86% of the patients have reported

that cancer pain affect activities of daily living, including 87% of sleep, 92% their focus and

concentration and 67% excessive reliance on others. According to the study, only 34% of the people

having cancer pain reported a good quality of life.

Anxiety is also a common distress in cancer patients. Cancer is a threatening event which made

patients feel anxious. According to Jenkins et al (1998), the anxiety in cancer population is more

common than the general population without any chronic medical condition. According to Stark and

House (2000), anxiety can affect the quality of life of cancer patients, especially impaired social

functioning, physical and impairment and fatigue. Anxiety would produce a lot of typical signs and

symptoms including palpitation, sweating and restlessness. Cancer patients with anxiety may also

have poor concentration, muscle tension or fatigue.

According to Cassileth and Vickers (2004), human touch can be useful as an intervention to treat

against pain and other sign and symptoms. It can be a non-invasive and inexpensive intervention for

pain management and other symptoms for patients with chronic illness. Massage therapy is defined

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as the manipulation of the body’s soft tissue areas, which help to assist people to relax, facilitate

sleep and also relieve muscular aches and pains (Vickers and Zollman, 1999). Several findings have

reported the beneficial effects of massage therapy in reducing pain and anxiety level in oncology

patients.(Cassileth and Vickers, 2004; Gatlin and Schulmeister, 2007) Massage therapy may help in

relieving pain and anxiety level of cancer patients in the current setting.

1.2 Affirming the Need

The target setting is the adult Haematology and Oncology wards and Oncology Day Care Centre of

a private hospital in Hong Kong (Hospital A). Every year, there would be around 8000 inpatients

and 4000 outpatients. Around 80% of the inpatients are oncology patients. Others may be overflow

medical patients. About 40% of the patients are admitted for chemotherapy. 25% of the patients are

admitted for palliative care while 35% are admitted for supportive treatments. Most of the patients

admitted to the oncology ward claimed that they feel pain and are very anxious about their illness.

About 60% of the patients in the target setting complain poor pain control and are given

pharmacological treatments. For patients having metastatic cancer, they suffer cancer pain more.

The World Health Organization has developed a three step ladder for cancer pain relief in adults.

The pain-relief medications should be from non-opioids to mild opioids to strong opioids. However,

cancer pain still remains a problem in the health care settings and would seriously affect the quality

of life of patients. Some of the patients refused to used a high dose of opioids to relive their pain

level as they afraid of being addiction or drug tolerance (Gatlin & Schulmeister, 2007). Some

patients are afraid of having the side effects of analgesics including nausea and vomiting,

respiratory distress, drowsiness, confusion and urinary retention (Falkensteiner et al, 2011). Patients

always ask if they could take fewer pills.

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Anxiety in cancer patients can be divided into four different types, including situational anxiety,

disease related anxiety, treatment related anxiety and an exacerbation of pre-treatment anxiety

disorder (Pandey et al, 2006). In the Hospital A, patients usually got disease related anxiety as they

are fear of the side effects of cancer and are afraid of death. Over half of the admitted patients will

feel anxious towards their treatment plans and also fear of the future. Cancer patients needing

chemotherapy in the target setting are very worried about the side effects of the drugs such as

nausea and vomiting, fatigue and altered body function. Severe anxiety would induce cancer related

depression which is a pathological response to the loss of normality and one’s personal world due to

the cancer diagnosis, treatments or the complications. As mentioned above, Hospital A has patients

having cancer related depression. However, anxiety is always left ignored in the health care

settings. Doctors and nurses will just ask the cancer patients not to be nervous and anxious but

nothing will be done. Some doctors may prescribe the anxiolytic drugs. However, some of the

widely used anxiolytic drugs would induce side effects of amnesia, interaction with alcohol,

drowsiness or withdrawal effects (Spooren et al, 2000). If severe anxiety developed causing

psychological depression, clinical psychologist will then be referred. Luckily, only 5% of the

anxiety cases have to be referred to the clinical psychologist.

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In some studies, massage therapy could lead to large and immediate improvements in relieving

signs and symptoms in cancer patients (Cassileth and Vickers, 2004). Although massage therapy

has been used as an adjuvant strategy in reducing cancer pain and anxiety for oncology patients in

some other countries, there is no clear evidence-based guideline for massage therapy in Hong Kong

health care clinical settings. In the target ward, there is no guideline for the manipulation of

massage therapy for cancer patients. Pain and anxiety are treated pharmacologically. If massage

therapy can be applied in the target ward, cancer patients would benefit from the intervention and

hence relieve their signs and symptoms of cancer pain and cancer-related anxiety.

No evidence-based guidelines about massage therapy in relieving pain and anxiety of cancer

patients were done before. There is no published systematic review done on this topic. However,

there are some good studies which could help to develop certain evidence-based guidelines for

cancer patients. Therefore, a systematic review will be performed to investigate if massage therapy

can be useful in relieving cancer pain and anxiety.

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1.3 Objectives and Significance

In order to develop an evidence-based guideline of using massages therapy to reduce pain and

anxiety level in oncology patients, the following objectives are formed:

1. To evaluate current evidence on the effectiveness of using massage therapy to reduce pain and

anxiety level in oncology patients.

2. To assess the implementation potential including the transferability and feasibility of using

massage therapy for oncology patients in a local oncology ward.

3. To develop the evidence-based guideline on the implementation of massage therapy to reduce

pain and anxiety level of cancer patients.

4. To develop an implementation plan and evaluation plan for the massage therapy on cancer

patients in a local oncology ward.

Pain and anxiety distress affect most of the cancer patients. A good and effective evidence-based

guideline for pain management and anxiety relief by massage therapy would be beneficial to

patients, relatives and health care professionals.

An evidence-based guideline of massage therapy can help to standardize the treatment in our

nursing practices. It can relieve the pain and anxiety level of cancer patients, hence improving their

quality of life. Some of the patients may refuse active treatments such as chemotherapy due to the

high intensity of distress and side effects caused by the treatments. The introduction of massage

therapy could help build up a supportive relationship among the patients and the health care

professionals. Family members can also learn to use the massage techniques to help support the

patients at home after discharge. If pain and anxiety of the patients are relieved, they may have a

better quality of life and create a positive attitude towards their life.

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Chapter 2: Critical Appraisal

Appropriate searching strategies of different relevant evidence and results would be demonstrated in

this chapter. Critical appraisal would be performed and each relevant evidence would be rated using

the Scottish Intercollegiate Guidelines Network (SIGN) checklist (SIGN,2015). Finally, a summary

of the selected studies and synthesis would be presented.

2.1 Search and Appraisal Strategies

2.1.1 Inclusion and exclusion criteria for the study selection

Before the selection, inclusion and exclusion criteria have to be developed to determine eligible

studies. For the inclusion criteria, the methodology of the studies should be randomized controlled

trials (RCT) as RCTs have the high level of evidence. Besides, the studied participants should be

aged 18 years old or above and are diagnosed with cancer as the target population is adult oncology

patients. Furthermore, massage therapy should be used as an intervention in all the studies. At least

one of the outcome measures of each study should be related to either pain or anxiety. For exclusion

criteria, massage therapy for other cancer symptoms relief would be excluded.

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2.1.2 Search Strategy

Using two electronic databases, PubMed and CINAHL plus (EBSCOhost) via the University of

Hong Kong Library database, a search was conducted on 10th December, 2015 to identify eligible

studies. First of all, the term “chemotherapy”, “oncology”, ”cancer”, “malignant” and “carcinoma”

were searched using the function “OR” to identify studies for the target population oncology

patients. After that, the term “pain”, “anxiety”, “anxious”, “mood”, “cortisol” and “psychological”

were searched using the function “OR” to identify the outcome measures of the study. Finally,

using the combination of all the above search results together with “massage” which is the

intervention, a list of results would be listed out. Studies were screened using the above inclusion

and exclusion criteria by title, abstract, and followed by full text. For the year of publication, there

is no restriction. Reference list of the search results are gone through to identify additional studies.

2.1.3 Appraisal strategies

The quality of the identified studies was assessed by SIGN checklist (2015). The level of evidence

was rated according to the critical items of the SIGN Randomized Controlled Trial checklist.

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2.2 Results

2.2.1 Search Results

After using the above keywords for search and filtered with RCT, 28 articles were identified from

PubMed and 8 articles were identified from CINAHL plus. After eliminating the duplicated studies,

35 articles were found. After screening each of the 35 articles manually and by using the above

inclusion and exclusion criteria, 5 RCTs were selected. For details, please refer to the search history

in Appendix A.

Records identified through database searching of PubMed and CINAHL plus is 35. No more study

is retrieved after screening reference list of the selected articles. Hence, 35 records were screened.

After looking at the title and the abstract of the records, 21 records are excluded. Fourteen full text

articles were assessed for eligibility. After reviewing for the full text articles, 9 articles were

excluded as the target groups and the outcome measures did not match the selection criteria. Finally

5 studies were included in the qualitative synthesis. No addition is made from the reference list. For

details, please refer to the PRISMA flow diagram in Appendix B.

2.2.2 Data Extraction

In the table of evidence (Appendix C), all the key information of the selected studies was extracted.

The study design, quality, patients’ characteristics, intervention, control, outcome measures and

effect size of each of the studies were included in the table of evidence. The countries involved are

Taiwan (Wang et al, 2014), the United Kingdom (Stringer,Swindell and Dennis, 2008), the United

States (Toth et al, 2013 & Mehling et al, 2007) and Spain (Sedin et al, 2012). The sample size

ranged from 30 to 138. The intervention is massage therapy done on cancer patients while the

control is having no massage therapy.

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2.2.3 Appraisal results

All studies stated clearly-focused research questions. All the five selected studies have listed out the

use of randomization method. Only one study (Mehling et al, 2007) has mentioned an adequate

concealment method. An opaque envelopment was used. Most of the studies are single-blinded. It is

not possible for the patients to be blinded as they are the one who received the interventions. All

relevant outcomes are measured in a standard, valid and reliable way. Using the SIGN checklist to

evaluate the level of evidence of the RCTs, two studies are rated at 1- and three studies are rated as

1+. No studies are rated as 1++. For details, please refer to Appendix D.

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2.3 Summary and Synthesis

2.3.1 Summary of studies

Patients’ characteristics

The studied participants are patients with malignant ascites (Wang et al, 2014), non-malignant

ascites (Stringer, Swindell & Dennis,2008), haematology patients (Stringer, Swindell &

Dennis,2008), cancer patients having surgery (Mehling et al, 2007) or other cancer patients

(Toth,2013; Sendin et al,2012) All patients were recruited from oncology center in hospitals in

different countries (Wang et al, 2014; Stringer, Swindell & Dennis,2008; Toth,2013;Sendin et

al,2012; Mehling et al, 2007).

Intervention

Massage therapy was used as an intervention and was given by massage therapists from 15 minutes

to 45 minutes in all the studies. Massage was performed on the abdomen of the patients in one of

the studies (Wang et al, 2014). Specific area of massage was performed in other studies such as

massage over four limbs, back and head (Stringer, Swindell & Dennis,2008; Toth,2013). Massage

on the trigger points was also common (Sendin et al,2012). Full body massage was not possible in

all of the studies as the time is not feasible.

Swedish massage was used in most of the studies which include gentle effleurage and petrissage

Wang et al, 2014; Stringer, Swindell & Dennis,2008; Toth,2013). In general, massage therapy was

delivered during the hospitalization for two to three times per week except one which was carried

out in patients’ home (Toth et al, 2013).

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Control

For all studies, the control is the same which is receiving no massage therapy. The control group

receives no treatment or just having 15 minute social interaction. Only one study control group is

having a simple hand contact on the pain area (Sendin et al, 2012).

Outcomes

All five studies focused on the anxiety level among patients. One of the studies (Stringer, Swindell

& Dennis, 2008) focus on the serum cortisol level as the outcome measure. The serum cortisol level

is known to be directly linked with the hypothalamic pituitary adrenal axis and it is a hormone

influenced by chronic stress. Therefore, the higher the serum cortisol level, the higher is the stress

and anxiety level. Four studies focus on the pain level as the outcome measures except one focus on

just anxiety (Stringer, Swindell & Dennis, 2008). The common scale measures used in the Numeric

Rating Scale (NRS). One study use the Memorial Pain Assessment Card (MAPC) measuring the

pain intensity (Sendin et al, 2012).

2.3.2 Synthesis of studies

Massage therapy is shown to have significant effects of reducing pain or anxiety level in all of the

five studies. None reduced both pain and anxiety significantly. According to the results of the five

studies, massage therapy is suitable for all types of cancer patients. After studying the data of all the

five studies, the use of massage therapy in reducing pain and anxiety level in oncology patients are

synthesized as follow.

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Massage Method

Swedish massage was used in three of the studies (Wang et al, 2014; Stringer, Swindell &

Dennis,2008; Toth,2013). Swedish massage use smooth, long and rhythmical strokes as well as

gentle kneading of the body to provide comfortable feeling to cancer patients (Billhult, et al, 2007)

The other two studies did not mention the type of massage being used (Sendin et al, 2012; Mehling

et al, 2007).

Massage Duration

The massage duration of the studies ranged from 15 to 45 minutes in the 5 studies (Wang et

al ,2014; Stringer, Swindle and Dennis, 2008;, Toth et al,2013; Sendin et al,2012 and Mehling et al,

2007) The average duration of massage therapy would be 30 minutes. Longer duration did not give

a larger effect size. However, too short duration is not too good. Therefore, an average of 30

minutes for massage duration is chosen. In order to make the patients more satisfied and benefit

more from massage therapy, performing the massage therapy for two to three time per week (Wang

et al ,2014; Toth et al,2013). Several massage therapy sessions have to be performed but not too

often. Therefore two to three week per time would be the most suitable.

According to the five studies, the intervention lasts from one day to one month. There is no relation

between implementation duration and the effect size.

2.3.3 Conclusion

To conclude, massage therapy can be effective in reducing pain and anxiety level of oncology

patients after systematic review. Therefore, a massage program in the target oncology ward would

be proposed to be implemented using Swedish massage for 30 minutes, two to three times per week.

It is believed that the massage problem would reduce the pain and anxiety level of cancer patients in

the local oncology ward.

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Chapter 3: Translation and Application

In the previous chapters, the literature reviews of certain research studies have shown the

effectiveness of using massage therapy in reducing pain and anxiety level in oncological patients. In

this chapter, the implementation potential of this innovation would be assessed and hence an

evidence-based practice guideline would be developed to be applied in the target setting.

3.1 Implementation Potential

The transferability and feasibility of the massage therapy would be examined and assessed in the

following sessions. Therefore, the potential of implementing the innovation in the target setting can

be determined.

3.1.1 Target Setting

The target setting is the Haematology and Oncology wards and Oncology Day Care Centre of a

private hospital in Hong Kong (Hospital A). There are two wards including general ward and semi-

private ward for in-patients and the Oncology Day Care Centre for outpatients. General ward has 44

beds including 8 rooms which contains 3 to 6 beds and 2 isolation rooms while semi-private ward

has 25 beds in single room which includes 4 isolation rooms and 2 reverse isolation rooms. Both

wards are mixed ward. The Oncology Day Care Centre contains 15 beds for day care of oncology

patients providing chemotherapy or other palliative treatment. Every year, there would be around

8000 inpatients and 4000 outpatients. Around 80% of the inpatients are oncology patients. Others

may be overflow medical patients. There are around 70 patients eligible for the innovation every

day. It is estimated that around 70% of the eligible patients, that is 50 patients, would be fit for the

innovation as some eligible patients may refuse treatment. There are around 18,250 patients who

would be beneficial in one year.

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3.1.2 Target Users of the guideline

The target users are the nurses in the oncology ward and other allied health staff who assist in

massage therapy.

The target population are cognitively competent adult oncology patients who has experienced

anxiety and pain from different types of cancer with or without metastasis. Exclusive criteria of the

target population are patients who have any open wound over the body or patients having any

dermatitis. If patients’ platelet count is lower than 100,000/mm3 or have spinal cord injury or

having altered level of consciousness, they are also excluded (Wang et al ,2014; Stringer, Swindle

and Dennis, 2008;, Toth et al,2013; Sendin et al,2012 and Mehling et al, 2007).

3.1.3 Philosophy of care

“Quality in Service, Excellence in Care” is the motto of the target private hospital. The hospital

aims at providing the best medical treatments and hospital care for the patients and provide patient-

centered care with well-qualified and experienced nurses, doctors and other allied health

professionals. The mission and vision of the hospital is to increase the quality of life of patients. We

hope to minimise the suffer, both physiological and psychological distress, from cancer such as

anxiety and pain. Therefore, the dignity of the patients would be increased.

Massage therapy falls in the above philosophy of care. It is an alternative way other than

pharmacological methods to relieve the distress of oncology patients. Massage therapy is believed

to minimize the suffer of cancer patients and hence increase the quality of life of patients.

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3.1.4 Transferability of the findings

The innovation as mentioned above fit in the proposed settings. The target population in the above 5

research studies is similar to the target setting as the target settings in the studies are oncology

centers and the target patients in the research is adult oncology patients. All the research studies

have similar philosophy of care which is patient centered care. It is hoped that patients’ quality of

life would be increased and hence increase the dignity of patients. Around 80% of the target setting

patients can be benefited from the innovation.

3.1.5 Timeline for Implementation of the innovation

The first 4 weeks would be the preparation stage, including forming a communication team and

seeking approval from the Hospital Management and Nursing Administration. The next four weeks

would be the development of the evidence-based guideline and training. The next 4 weeks would be

pilot study. The next week would be amending guidelines and flow of the full-scale program. The

following 2 months would be implementation of the innovation and it takes one month for the

evaluation. In total, it takes around 7 months for the innovation. The total time for the innovation is

reasonable and acceptable. For details, please refer to Appendix E.

3.1.5 Feasibility of the innovation

3.1.5.1 Organizational and administrative support

Nurses would be the leader of the massage team, including members of massage therapists,

physiotherapists and other health care workers. Nurses have the autonomy to start or terminate the

massage therapy according to their clinical knowledge and patients’ condition. Hospital

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Management Committee and Nursing administration of the target hospital totally support for this

innovation as it is an evidence-based practice. Besides, the target hospital is a teaching hospital, all

the stakeholders understand well the importance of evidence-based practices to facilitate patient-

centered care and hence improve quality of life of patients. Recently, a donation of $ 50,000,000 is

donated by a celebrity for the nursing research and development. Therefore, extra manpower can be

recruited.

3.1.5.2 Continuous education for staff development

Nursing staffs and other allied health staff including ward assistant, physiotherapists may have

different attitude towards the implementation of this innovation which would affect the feasibility

of the implementation. However, hospital requires staff to have continuous education and

development on different aspects. Nurses and other allied health staff are required to take courses

organised by the hospital. Otherwise, their contract may not be renewed or they are not promoted.

Besides, staff attending the lectures of massage therapy or other courses related to this innovation

can have CNE points for nursing staff and time off may be given.

3.1.5.3 Support from frontline staff

Some of the frontline staff may dislike the additional workload. However, as the target setting is a

private hospital, it can provide a higher salary for staff and requires staff to be responsible and

comprehensive. Besides, as mentioned above, a large amount of donation is collected recently and

hence extra manpower can be recruited. This would not really interfere too much with the staff

function. This would increase the feasibility of implementing the innovation.

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3.1.5.4 Skills and equipment available

Professional massage therapists are employed to teach the skills of massage therapy to the nurses

and other allied health staff. Recruitment of professional massage therapists is easy as Hospital A is

the most famous private hospital which give higher salary for professional massage therapists then

other companies. The basic equipment of massage therapy includes mainly the staff, which are

well-equipped.

3.1.5.5 Evaluation tools

Patient’s outcome, patients’ satisfaction and nurse’s job satisfaction would be evaluated. The

evaluation tools are questionnaire and it can be easily prepared using the numeric rating scale

(Wang et al, 2014; Toth et al, 2013;Mehling et al, 2007) and the 5-point Likert Survey.

3.1.6 Cost-Benefit Analysis of the innovation

3.1.6.1 Potential Benefits of the innovation

As mentioned in previous chapter, oncology patients would experience both physical and

psychological distress. One of the non-pharmacological methods, massage therapy, can be used in

relieving pain and anxiety level of cancer patients (Wang et al ,2014; Stringer, Swindle and Dennis,

2008;, Toth et al,2013; Sendin et al,2012 and Mehling et al, 2007). With the help of non-

pharmacological agent, the use of pharmacological drugs could be minimised. Sometimes, there

may be side effects caused by medications. However, massage therapy does not cause side effects

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(Wang et al, 2014). Patients would not need to pay more for the drugs. Patients have less complaint

and hence would decrease nurses’ workload.

Besides, it would decrease the length of hospitalisation of patients (Mehling et al, 2007), therefore

increase patients’ satisfaction. Patients would be more willing to choose to stay and spend in the

target hospital for the next admission. It would also increase the reputation of the target hospital.

3.1.6.2 Potential Risks of the innovation

No adverse event for patients is reported in the research studies (Wang et al ,2014; Stringer,

Swindle and Dennis, 2008;, Toth et al,2013; Sendin et al,2012 and Mehling et al, 2007). Any

discomfort of patients would be stopped immediately.

3.1.6.3 Risk of the current practice

In current practice, pharmacological methods are used in target settings to treat pain and anxiety.

However, sides effects of pain killers and anti-anxiety drugs would cause adverse effects for

patients. Some may got constipation, nausea and vomiting. If pain and anxiety are not treated

properly, the patients would suffer from the adverse effects and hence have a negative feelings

towards the disease. It may develop a poor quality of life.

26

3.1.6.4 Non-material costs and benefits of the innovation

For the potential non-material costs of implementing the innovation, nursing staff and other allied

health staff such as ward assistant and physiotherapists may think it is an increase in workload as

they have to learn the skills of massage therapy at the beginning of the programme. However,

patients would have less complaint and hence the workload of staff would be decreased after

several sessions of massage therapy. That would then become the potential non-material benefit.

For a private hospital, there is no material savings for the hospital for the reduce use of

pharmacological drugs. However, it would increase the patient satisfaction of staying in the hospital

and hence improve the reputation of the hospital. Reputation of hospital is also a non-material

benefit. It would make the patients feel comfortable to choose Hospital A again. This would then

increase the income of the hospital.

3.1.6.6 Cost-Benefit Ratio

There are material costs and non-material costs. For the material costs, it includes the set up cost

and the operational costs. Set up cost include all the materials needed for massage therapy including

the recruitment of massage therapists and also the training costs of massage therapy for staff. For

the operational cost, it includes the regular recruitment of massage therapists and regular training

for staff.

Number of patients eligible for the innovation in the target setting is 70 patients per day. Assume

70% of the patients fit in the innovation, there are around 50 patients every day. Estimated time for

each treatment is 30 minutes. Number of massage therapists recruited at the beginning of the

27

innovation is 2 (Appendix F) After 8 weeks, the nursing staff and other allied health workers can

perform the massage without the supervision of massage therapists. For the estimated set-up costs

of the innovation, it includes the training of massage therapy by massage therapists and equipment

costs. The monthly salary of massage therapist would be $40000. The salary of the nurses would be

the same. Only time off would be given to the nurses and allied health staff to attend the training

sessions. The set up costs include the recruitment of massage therapists for training of nurses and

other allied health staff ($80,000), time off given for staff to attend training sessions ($26000) and

also the notes costs ($1000). The operational costs include the recruitment of continuous training of

frontline staff ($5200). The set up costs and operational costs are calculated. For details, please refer

to Appendix G.

If the pain and anxiety level of patients is treated well, the estimated day of hospitalization would be

reduced by one day. According to the admission information of Hospital A, the average length of

stay of each patients in Hospital A is 5 days. Therefore, if massage therapy is implemented, the

number of patients admitted more in one month would be 10. The average spent for each stay for

each patient for either chemotherapy or palliative treatment would be $100,000. This would also

increase the hospital income by $1,000,000. The detail is shown in Appendix H.

In conclusion, implementing massage therapy to relieve pain and anxiety level of cancer patients

has a high cost-benefit ratio (around 1:9). It is transferable and feasible to implement this evidence-

based practice in the target setting.

28

3.2 Evidence-based Practice Guideline

The evidence-based practice guideline is developed according to the systematic reviews done in the

previous chapter. The evidenced-based practice guideline would provide clear and structural details

for nurses on the use of massage therapy on adult oncology patients to reduce their pain and anxiety

level in the target setting. The level of evidence and recommendations of the five randomized

controlled trails extracted from the previous chapter are graded according to the Scottish

Intercollegiate Guideline Network (SIGN, 2008), which would be shown in appendix I and

appendix J respectively. “ 1+ “ means well-conducted meta-analyses, systematic reviews, or RCTs

with a low risk of bias. “1-“ means meta-analyses, systematic reviews, or RCTs with a high risk of

bias. Grade A of Scottish Intercollegiate Guideline Network means there is at least one meta-

analysis, systematic review, or RCT rated as 1++, and directly applicable to the target population.

In the evidence-based practice, the aim, objectives, target group, recommendations and evidence

supporting the recommendations would be mentioned in details. There are 6 recommendations and

three are in Grade A and three are in Grade B. The detailed evidence-based practice guideline

would be shown in appendix K.

29

Chapter 4: Implementation Plan

After the evidence-based guideline being developed in the last chapter, an implementation plan and

evaluation plan will be focused and elaborated in this chapter. An implementation plan can facilitate

effective communication for illustrating the program of massage therapy into the target setting for

oncology patients to reduce their pain and anxiety level.

4.1 Communication Plan

The communication plan includes the introduction of the stakeholders for the program, introduction

of the process of forming a communicating team to sustain the change. A comprehensive

communication plan would be formed according to the feasibility of the massage therapy mentioned

in previous chapter. For the details of timelines of the program, please refer to appendix E.

4.1.1 Identification of stakeholders

The stakeholders are the key persons who would affect the successfulness of implementing the

evidence-based guideline of the massage program. The key stakeholders include the Hospital

Management Committee, Director of Nursing Administration, ward manager of Oncology

Department, oncologists, oncology nurses and finically the oncology patients.

The Hospital Management Committee and the Director of Nursing Administration are the most

important stakeholders as they are the one who make the decision and make guidelines and

implement the interventions in the target setting. Approval has to be obtained by the Nursing

Administration followed by the Hospital Management Committee before any actions can be done.

30

Another stakeholder would be the ward manager of Oncology Department. Massage therapy would

be done in oncology ward and oncology center. The ward manager has to supervise the flow of the

massage intervention and she has to ensure that the program would not interfere with the normal

routine practice of the target setting.

Five Oncologists and around 30 oncology nurses are the frontline staff responsible for giving

treatments to oncology patients. They are the one who keep in contact with the patients every day.

They are the one who understand the patients’ condition well. Oncologists would be one of the key

stakeholders as oncologists are responsible for the overall health condition of the patients. and make

sure the patients are fit for the massage treatment. For oncology nurses, they are the one who would

assess the eligibility of oncology patients for the massage program and hence run the massage

program. They are also the one who give the massage therapy or supervise others allied health staff

to perform the massage therapy. Other allied health staff such as physiotherapists would also help in

performing the massage therapy, depending on the current workload of them.

Another important stakeholder is the oncology patients because they are the receiver of the massage

intervention. Reducing pain and anxiety level of cancer patients is important.

4.1.2 Communication Plan with Stakeholders

To initiate with the massage therapy program, effective communication has to be done to ensure we

could get supports from different parties including the hospital management committee, nursing

administrators, nursing leaders, oncologists, frontline nurses and oncology patients. The aim of the

communication plan is to make the stakeholder understand well of the program and increase the

successful rate of the implementation.

31

4.1.2.1 Communication in initiating the change

To start with, a communication team is formed which includes three oncology nurses in the first 4

weeks. First of all, the ward manager of the oncology department would be approached by the

communication team. Tell the ward manager the proposed program in a meeting. Explain the

significance, transferability, feasibility and the potential cost and benefits of the innovation. Identify

the expected barriers for implementing the program and discuss the solutions for the innovation.

The ward manager has a higher authority in policy making related to nursing practice than frontline

nurses. The ward manager can also give comments and see how the implementation can be more

successful. If it is supported by the ward manager, she will mention the innovation to the Nursing

Administration and meeting would be arranged.

Communicate with the Nursing Administration, give written proposal and presentation to the

Nursing Administration by the communication team. If it is supported and approved by the Nursing

Administration, the next step is to contact and communicate with the Hospital Management

Committee to see how the innovation can be implemented. The Hospital Management Committee

would study the proposal which include the aim and objectives of the guidelines and also the

implementation potential, effectiveness of the innovation and the cost of and benefit of the massage

program. If it is approved by the Hospital Management Committee, financial support would be

granted and hence a massage therapy team could be formed.

32

4.1.2.2 Communication in forming a massage therapy team

After being approved by the Nursing Administration and Hospital Management Committee, a

communication team for massage therapy on oncology patients would be formed to plan and launch

the innovation. The massage therapy team would include the oncology nurse as a team leader,

which includes members of 5 nursing staffs, 2 temporarily employed massage therapists,4

physiotherapists and 5 other allied health staff. Meetings would be organized and held regularly to

discuss the planning of the program. Besides, recruitment of massage therapists to give training

sessions for nursing staff and other allied health staff to perform massage therapy.

Frontline nurses and allied health staff would be informed about the proposal through internal

poster and email. Evidence-based guidelines would be distributed to oncology ward and oncology

center. Staff are compulsory to attend the training session organized by the massage therapy team

and they are required to be assessed from time to time as it is a continue educational and

developmental program developed by the hospital. The importance of the massage innovation

would be emphasized during the communication to the frontline staff. Performing quality of care

and service are the motto of Hospital A. It is for the patients’ benefit and frontline should be happy

about helping the oncology patients.

33

4.2 Pilot Study

A pilot study would be performed so that the logistics of the proposed innovation would be studied.

The pilot study is a small scale preliminary study which will be done in the target settings for a

short period of time with a small amount of cancer patient in oncology wards and oncology center.

The data collected from this pilot study would be useful in determining whether the proposed

innovation and evidence-based guideline is feasible and workable. Further modification can be

made on the guideline and the financial planning can be adjusted for the large scale implementation

when necessary.

4.2.1 Objectives of the pilot study

(i) Identify the barriers and difficulties of implementing the innovation.

(ii) Collect information to fine-tune the logistics for the full-scale implementation.

4.2.2 Study Setting of the target population

The study will be conducted in the oncology wards by nurses and other allied health professionals.

First of all, a training program of massage therapy would be conducted by a massage therapist.

Oncology nurses are the major target of being trained. Besides, allied health care professionals such

as physiotherapists, health care workers are also trained with the techniques of massage therapy.

The training would be a 5 session training courses with each session of 2 hours. The training

program would last for 2 weeks.

34

After training, 4weeks would be used to recruit eligible patients for massage therapy. The eligible

patients are mentioned in previous chapter. Patients having diagnosis of cancer who are aged 18 or

above which are cognitive competent and have experienced pain or anxiety are eligible for the

program. Convenience sampling is used and 20 patients would be recruited for the study. 30

minutes would be provided to the patients having pain or anxiety level for at least twice per week

during hospitalization. Details are based on the evidence-based guidelines. Pre and Post pain

assessment and anxiety assessment would be done to evaluate the massage therapy program.

After 4 weeks, a short evaluation by interview of frontline staff and oncology patients who receive

massage therapy would be done before proceed to the full-scale implementation. Further

modification of the full-scale innovation would be made according to the flow of the pilot study and

make better outcomes. The pilot study would make a better flow and better logistics of the program.

35

4.3 Evaluation Plan

Evaluation is an essential part of assessment for the implementation of the massage program. It is a

tool to determine the effectiveness of the program. Outcome benefits regarding patients, health care

providers and hospitals will be illustrated in the following sessions.

4.3.1 Identifying Outcomes

4.3.1.1Primary Outcome

Patient outcome is the primary outcome of the above innovation. Pain and anxiety level of oncology

patients are the primary outcomes. The patient outcomes could determine the effectiveness of the

program. Pre massage therapy pain and anxiety level would be assessed as baseline and then post

massage therapy pain and anxiety level would be assessed and compared. Numeric rating scale

(NRS) in which zero represents symptom absent and 10 represents the worst possible symptom

would be used to measure the pain and anxiety level. Time for collecting the patient outcomes is

right before the massage procedure and 30 minutes after the procedure. For the details of the

assessment form, please refer to Appendix L

4.3.1.2 Secondary Outcome— Patient Outcome

One of the secondary outcomes is the satisfaction level of the patients. The higher the satisfaction of

the patients, the higher the effectiveness of the massage innovation and hence increase the

reputation of the hospital. A 5-point Likert Survey would be done to measure the satisfaction level.

The higher the score (0-5), the better the satisfaction level. There are 6 questions on the

questionnaire. The patient will complete the questionnaire before discharge. The average score of

36

questionnaire would be calculated. For the details of the questions in the questionnaire, please refer

to Appendix M.

4.3.1.3 Secondary Outcome— Health Care Provider Outcome

The nurse’s job satisfaction is another secondary outcome of the innovation. Nursing job

satisfaction has to be evaluated every 2 weeks of the implementation. The job satisfaction of nurses

would be assessed via a self-reported questionnaire. A 5-point Likert Survey would be done to

measure the job satisfaction level of nurses. The higher the score (0-5), the better the satisfaction

level. There are 5 questions in total. The nurse would complete the questionnaire at the end the

implementation period. The mean score would be calculated. For details of the staff self-reported

questionnaire on the use of the massage innovation, please refer to Appendix N.

4.3.1.4 Secondary Outcome – System Outcome

For the system outcomes, the costs and utilization of the innovation would be measured to ensure

the effectiveness of the massage programme. The implementation of the innovation can cause the

reduced length of hospitalization of the patients and hence getting more number of patients admitted

in one month. The estimated expenditure of the innovation is calculated and the money gained for

extra patients per month is compared.

37

4.3.2 Nature and number of patients to be involved

Target patients of the innovation are oncology patients having experience of pain or anxiety during

hospitalization. The eligible criteria of the patients are mentioned in previous chapter. Patients

should be aged 18 or above and be cognitively competent who should have GCS =15/15. Exclusive

criteria of the patients include patients having any open would over the body, any dermatitis, lower

platelet count, spinal cord injury and altered level of consciousness. In order to carry out a

comprehensive intervention and evaluation, an adequate sample size is needed. The sample size

calculation is based on the five selected research articles. A two tailed t-test would be used to

determine the reduction of pain and anxiety level. With reference to previous research studies, a

standard deviation of 1, a mean difference of 0.5 with alpha= 0.05 and power =80% were used to

calculate the sample size. 33 patients have to be recruited according to the sample size calculation.

However, if we assume there is a 5% drop out rate due to change in condition of patients, the

number of patients needed to be recruited is around 40. It is estimated to take 3 months to recruited

40 patients to have completed at least one massage intervention.

4.3.3 Data analysis

The baseline and post massage intervention pain and anxiety level collected using the Numeric

Rating Scale would be used for data analysis using the Statistical Package for Social Sciences

(SPSS) program. A two tailed t-test would be done to test whether the pain and anxiety level

significantly declined by at least 0.5 units or not.

For the other secondary outcomes, the patients’ satisfaction level and the nurse’s job satisfaction

level would be calculated using the 5-point Likert scale. An average score would be calculated. The

higher the score (0-5), the better the satisfaction level. The 95% confidence interval of the

percentage of mean score greater than or equal to 4 would be calculated. Descriptive statistics

would also be generated for system outcomes.

38

4.4 Basis for Implementation

The guideline is said to be effective is based on the basis for the outcome achievement. If the

following outcomes can be achieved, the innovation is said to be effective.

4.4.1 Patient’s Outcome

The innovation is said to be effective if patients’ pain or anxiety level have a reduction of 0.5 or

more points using the Numeric Rating Scale.

4.4.2 Patients’ Satisfaction and Nurse’s Job Satisfaction

If more than 70% of the patients’ satisfaction towards the massage therapy and nurse’s job

satisfaction have an average score of 4 or above, then the innovation is said to be effective.

The massage therapy innovation is said to be effective in the target setting if all the above

achievements are made.

39

Chapter 5: Conclusion

Pain and anxiety are the most common physiological and psychological distress experienced

by oncology patients. A translational nursing approach is adopted to develop an evidence-based

guideline on reducing the pain and anxiety level of oncology patients for a local oncology center. A

pilot study plan, implementation plan and finally an evaluation plan are developed including the

evaluation on the clinical outcomes, health care providers’ outcomes and system outcomes. It is

believed that the proposed massage therapy innovation would be considered an effective measure in

reducing pain and anxiety level in oncology patients. Reduction in pain and anxiety level of patients

would bring a better quality of life to patients, improving the nurse job satisfaction and also increase

the reputation of Hospital A.

40

Appendix A: Summary of Database Search Strategy and Result

Summary of Database Search Strategy and Result

Search Items Electronic Databases

PudMed CINAHLplus (EBSCOhost)

S1: Chemotherapy OR

oncology OR cancer OR

malignant OR carcinoma

5380440 61992

S2: pain OR anxiety OR

anxious OR mood OR cortisol

OR psychological

1682801 87943

Massage AND S1 AND S2 570 68

Limit to Randomized Control

Trial

28 8

Addition from reference list 0 0

Total number of articles

retrieved without overlapping

35

41

Appendix B: PRISMA Flow Diagram

Records identified through database PudMed and CINAHLplus

(n = 36 )

Scr

een

ing

Incl

ud

ed

Eli

gib

ilit

y

Iden

tifi

cati

on

Additional records identified through other sources

(n =0 )

Records after duplicates removed (n = 35 )

Records screened (n = 35 )

Records excluded (n =21 )

Full-text articles assessed for eligibility

(n =14 )

Full-text articles excluded, (n = 9 )

Reasons: Target groups are different (n=5)

Outcome measure are different (n=4)

Studies included in qualitative synthesis

(n = 5 )

42

Appendix C: Table of evidence

Citation /

Design (Study

Quality)

Sample

Characteristics

Intervention Control Outcomes (Assessment

time)

Effect Size

(Intervention -

Control)

1 Wang, T.J

et al (2014)

1+

1. Cancer patients

with malignant

ascites

2. Studied in

Northern

Taiwan

15 minute gentle

abdominal massage

twice daily for 3

consecutive days

(Swedish Massage)

(n=40)

15 minute social

interaction

contact with the

patient twice

daily for 3

consecutive days

with the same

nurse

(n=40)

1. Anxiety

(NRS)*

2. Pain (NRS)

(measured in

the morning for

3 consecutive

days from pre-

to post-test)

Measure from

Day 3:

1. Difference of

Mean: -0.58;

SE: 0.16, p=

<0.001

2. mean:0.37,

p=0.187 (Not

significant)

2 Stringer, J,

Swindell,

R, Dennis,

M (2008)

1+

1. Haematology

patients

including non-

malignant

patients.

2. Studied in

oncology centre

of the Christie

Hospital in

Manchester

1. Massage for 20

min (with base

oil) for two days

(Swedish Massage)

2.

(N= 13)

3. Aromatherapy

for 20

min(Massage

with blended

oils) for two days

(N=13)

Rest

(Patients were

made

comfortable,

offered reading

material and soft

drinks and are not

disturbed by staff

for 20 min)

(N=13)

1. Serum

Cortisol

Level ^

(measured at 24

hour follow

up)

Compared

between Massage

and Control:

1. Median: -

18.3,

p=<0.0005

Compared with

Aroma and

Control:

1. Median: -

12.5, p=0.034

3 Toth, M. et

al (2013)

1-

1. Patients with

metastatic

cancer

2. Studied in Beth

Israel

Deaconess

Medical Center

in Boston

massage treatments

by massage therapists

three time per week

for 15 to 45 min

(Swedish Massage)

(n=20)

Patient received

no massage

treatment

(n=19)

1. Pain (NRS)

2. Anxiety

(NRS)

(assessment

time: one

month)

1. Mean: -0.9 ;

p= 0.04

2. Mean: -0.3;

p=0.72 (Not

significant)

4 Sendin, N.

L et al

(2012)

1-

1. Terminal

cancer patients

2. Studied in

Oncology

University

Hospital

Salamanca

massage was done on

the tender points for

30 minutes once

(Type of massage

therapy not

mentioned)

n= 15

receive a simple

hand contact on

the pain area

once

n=15

Primary

outcome:

1. Pain

(MPAP)#

Secondary

outcome:

2. Mood

(MPAP)

(measured at 30

minutes after

massage)

1. Mean: 0.2

p= 0.07

(not

significant)

2. Mean: 1.7

p<0.01

43

*Numeric rating scale (NRS) in which 0=symptom absent and 10=worst possible symptom

^High serum cortisol level means increase in stress and anxiety level

#Memorial Pain Assessment Card (MPAC) measuring the changes of pain intensity (0-10 ; 10: worst pain)

5 Mehling,

W,E. el at

(2007)

1+

1. Cancer patients

having surgery

2. Studied in

California

1. Massage were

given on post-

operation Day 1

and Day 2 at

bedside for 30

minutes

2. Acupuncture

treatment based

on symptom

report and

physical exam

(Type of massage

therapy not

mentioned)

(N=93)

Usual care with

no massage or

acupuncture

(N=45)

Primary

Outcome:

1. Pain

(NRS)

Secondary

Outcomes:

2. Anxiety

(NRS)

(assessment

time: day 3)

1. Mean Score: -

0.8, p=0.038

2. Mean

Change:-0.28,

p=0.15 (not

significant)

44

Appendix D: SIGN Checklists Record 1:

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages)

Wang, T. J., Wang, H. M. & Yang, T. S. (2015). The effect of abdominal massage in reducing malignant ascites symptoms.

Research in Nursing & Health, 38 51-59.

Guideline topic: Key Question No: Reviewer:

Before completing this checklist, consider:

1. Is the paper a randomised controlled trial or a controlled clinical trial? If in doubt, check the study design algorithm

available from SIGN and make sure you have the correct checklist. If it is a controlled clinical trial questions 1.2, 1.3, and

1.4 are not relevant, and the study cannot be rated higher than 1+

2. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison Outcome). IF

NO REJECT (give reason below). IF YES complete the checklist.

Reason for rejection: 1. Paper not relevant to key question ⬜ 2. Other reason ⬜ (please specify):

SECTION 1: INTERNAL VALIDITY

In a well conducted RCT study… Does this study do it?

1.1 The study addresses an appropriate and clearly focused question. Yes

1.2 The assignment of subjects to treatment groups is randomised. Yes

Use random allocation software

1.3 An adequate concealment method is used. No

1.4 The design keeps subjects and investigators ‘blind’ about treatment allocation. Yes

Outcome assessor is blinded.

However, blinding is impossible for

patients as they received the

treatment.

1.5 The treatment and control groups are similar at the start of the trial Yes

45

1.6 The only difference between groups is the treatment under investigation. Yes

1.7 All relevant outcomes are measured in a standard, valid and reliable way. Yes.

1.8 What percentage of the individuals or clusters recruited into each treatment arm of

the study dropped out before the study was completed?

None

1.9 All the subjects are analysed in the groups to which they were randomly allocated

(often referred to as intention to treat analysis).

Yes

1.10 Where the study is carried out at more than one site, results are comparable for all

sites.

Does not apply

study was carried out in a medical

center in northern Taiwan

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise bias?

Code as follows: High quality (++)

Acceptable (+)

Low quality (-)

Unacceptable – reject 0

2.2 Taking into account clinical considerations, your

evaluation of the methodology used, and the statistical

power of the study, are you certain that the overall effect is

due to the study intervention?

Yes

2.3 Are the results of this study directly applicable to the

patient group targeted by this guideline?

Yes

2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and the extent to

which it answers your question and mention any areas of uncertainty raised above.

Abdominal massage is useful for ascites symptoms. The study shows that abdominal massage twice daily for 3 days

significantly reduced the severity of depression, anxiety, poor wellbeing, and perceived abdominal bloating. However,

only short term effects of 3 days of abdominal massage were tested in this study, the long term outcomes and potential

side effects is undetermined

1+

46

Record 2:

S I G N



Stringer, J., Swindell, R. & Dennis, M. (2008). Massage in patients undergoing intensive chemotherapy

reduces serum cortisol and prolactin. Psycho-Oncology, 17 1024-1031.



1. Is the paper a randomised controlled trial or a controlled clinical trial? If in doubt, check the study design

algorithm available from SIGN and make sure you have the correct checklist. If it is a controlled clinical trial

questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+

2. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison

Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.





1.2 The assignment of subjects to treatment groups is randomised. Yes By computerised randomisation

block method

1.3 An adequate concealment method is used. No.

1.4 The design keeps subjects and investigators ‘blind’ about treatment

allocation.

Yes

It is only possible to use single

blinding. The lab staff

performing the hormone assays

and research assistnat collecting

psychological data were unaware

of the treatment allocation.

47



1.7 All relevant outcomes are measured in a standard, valid and reliable way. Yes. Serum cortisol and prolactin levels

is measured

1.8 What percentage of the individuals or clusters recruited into each treatment

arm of the study dropped out before the study was completed?

None

1.9 All the subjects are analysed in the groups to which they were randomly

allocated (often referred to as intention to treat analysis).

Yes

1.10 Where the study is carried out at more than one site, results are comparable

for all sites.

Does not apply

Study is carried in one

hospital only.




Acceptable (+)

Low quality (-)



evaluation of the methodology used, and the

statistical power of the study, are you certain that the

overall effect is due to the study intervention?

Yes.



Yes

2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and the

extent to which it answers your question and mention any areas of uncertainty raised above.

Massage can have psychological effects on patients. Reduced cortisol level due to reduction of stress and

anxiety. However, sample size is not large enough as n=39

1+

48

Record 3:

S I G N



Toth, M., Marcantonio, E. R. & Davis, R. B. (2013). Massage Therapy for patients with metastatic cancer: A

pilot Randomised controlled Trial. The journal of alternative and complementary medicine, 19 (7), 650-656.













By computerised randomisation



allocation.

No The authors not able to

blind the pre-post intervention

data collection



49

1.7 All relevant outcomes are measured in a standard, valid and reliable way. Yes. outcome measure Pain: NRS

Anxiety: NRS



None



Yes


for all sites.

Does not apply

Studied in Medical Centre in

Boston only




Acceptable (+)

Low quality (-






Yes



Yes



Patient expectation for better outcome from massage might have biased the study against the control. The

small sample size limits the statistical power. Need to have larger sample size

1-

50

Record 4:

S I G N



Sendin L., Sedin, F. A. & Cleland, J. A. (2012). Effects of physical therapy on pain and mood in patients with

terminal cancer: a pilot randomised clinical trial. the journal of alternative and complementary medicine, 18

(5), 480-486.













computer-generated randomized

table of numbers



allocation.

Yes A therapist blinds to

group assignment collected all

outcomes. However, patients

are not blinded.


51



MPAP for pain and mood



37.5%

(due to death, sedation or

refused)



Can’t say.


for all sites.

Does not apply




Acceptable (+)

Low quality (-)






Yes



Yes



Sample size is small and drop out rate is too high.

1-

52

Record 5:

S I G N



Mehling, W. E., Jacobs, B. & Acree, M. (2007). Symptom management with massage and acupuncture in

postoperative cancer patients: a randomised controlled trial . Journal of pain and symptom management, 33

(3), 258-266













(Using a computerised random

number generator prepared by study

statistician who has no contact with

participants)

1.3 An adequate concealment method is used. Yes

(An Opaque envelop is used)


allocation.

Yes


53



using NRS for pain and POMS-SF

for mood



4%



Can't Say


for all sites.

Does not apply




Acceptable (+)

Low quality (-)






Yes



Yes



Primary outcome, pain, is significant but secondary outcome, anxiety, is not significant. Concealment method

is mentioned. Sample size is large.

1+

54

Appendix E: Timeline for implementation of the massage program

Week 0-4 Week 5-8 Week 9-12 Week 13 Week 14-

week 25

week 26-28 week 30

1. Formation

of a

communicati

on team

————>

2. Seeking

approval

from the

Hospital

Management

and Nursing

Administrati

on.

————>

3. Refining

the guideline ————>

4. Training

to nurses

and allied

health

professional

————>

5. Pilot

Study ————>

6. Amending

guidelines

and flow of

the full-scale

program

————>

7.Implement

ing the

program

————>

8.Evaluating

the

Outcomes

————>

9.Generating

report from

the findings

————>

55

Appendix F:

Estimated number of massage therapists recruited

Estimated Number of massage therapists recruited

No. of patients eligible for the

innovation

70 patients/day

No. of patients fit for the

innovation

70 X 70 %

= 49

i.e ~ 50 patients/day

* 70% of the patients eligible

would be fit for the

innovation as some may

refuse the treatment

Massage time for each

patient per day

15-30 min 22(=50x3/7) “30-min” session

of massage therapy every day

Working minute for each

massage therapist per day

8 X 60

= 480 min

each massage therapist work 9

hours with 1 hour for

lunchtime

No of “30-min” sessions for

each massage therapist can

conduct each day at the

beginning of the innovation

480/ 30

= 16 sessions

No of massage therapists

have to be recruited

22/16

= 1.4

Spare time will be used to train

nurses are allied health staff are

trained. So the estimated

number of massage therapy

would be two.

However, the massage therapists are recruited for giving training sessions and

supervisor the staff’s performance, therefore 2 massage therapists could be

recruited for the first 8 weeks.

56

Appendix G:

Estimated Material costs for the innovation

Estimated materials costs for the innovation

Set up Costs

Operational Costs

Items

Calculations Items Calculations

Recruitment of

massage therapists for

training of nurses and

other allied health staff

(cover the first 8

weeks)

$40000 x 2 =$80000

Time off given for around

10 staff to attend the

training sessions (at least 5

sessions of 2 hours)

$260 X2X5 X10 = $26000

Time off given for

around 10 staff to

attend the training

sessions (have

continuous training for

staff)

(one session per month

of 2 hour)

$260 X 2 X 10 =$5200

Equipment costs (e.g

notes)

$1000

Amount

$107,000 Amount $5200

Total amount of

materials costs

$112,200

57

Appendix H:

Benefit of implementing the innovation

Benefit of implementing the innovation

Estimated day of hospitalization decreased

1 day per patient

No. of day saved

50

No. of patients admitted more in one

month

50/5

=10

* average length of stay for

each patients= 5

Average spent for each stay for each

patient (either chemotherapy or palliative

treatment)

$100,000

Total money gained for the extra patients

per month

$1,000,000

Benefit > Cost

58

Appendix I: Level of Evidence SIGN grading system: Level of evidence (Scottish

Intercollegiate Guidelines Network, 2008)

1++ High quality meta-analyses, systematic reviews of RCTs, or RCTs with a very

low risk of bias

1+ Well-conducted meta-analyses, systematic reviews, or RCTs with a low risk of bias

1- Meta-analyses, systematic reviews, or RCTs with a high risk of bias

2++ High quality systematic reviews of case control or cohort or studies High quality case

control or cohort studies with a very low risk of confounding or bias and a high

probability that the relationship is causal

2+ Well-conducted case control or cohort studies with a low risk of confounding or bias and

a moderate probability that the relationship is causal

2- Case control or cohort studies with a high risk of confounding or bias and a significant

risk that the relationship is not causal

3 Non-analytic studies, e.g. case reports, case series

4 Expert opinion

Scottish Intercollegiate Guidelines Network. (2008). Key to evidence statements and grades of

recommendations. Retrieved 16th February, 2016, from

http://www.sign.ac.uk/guidelines/fulltext/50/annexb.html


59

Appendix J:

Grade of recommendation

SIGN grading system: Grade of Recommendation (Scottish Intercollegiate Guidelines

Network, 2008)

A At least one meta analysis, systematic review, or RCT rated as 1++, and directly

applicable to the target population; or

A systematic review of RCTs or a body of evidence consisting principally of

studies rated as 1+, directly applicable to the target population, and

demonstrating overall consistency of results.

B A body of evidence including studies rated as 2++, directly applicable to the

target population, and demonstrating overall consistency of results; or

Extrapolated evidence from studies rated as 1++ or 1+

C A body of evidence including studies rated as 2+, directly applicable to the target

population and demonstrating overall consistency of results; or

Extrapolated evidence from studies rated as 2++

D Evidence level 3 or 4; or

Extrapolated evidence from studies rated as 2+





60

Appendix K: Evidence-based practice guideline

Evidence-based practice guideline of using massage therapy to reduce

pain and anxiety level in oncology patients

Aim

The aim of this protocol is to develop guidelines for nurses and other allied health staff in day care

center and oncology wards of Hospital A on the use of massage therapy so as to reduce the pain and

anxiety level of oncology patients in the target setting.

Objectives

The objectives of this protocol are to:

1. Summarize the evidence-based practices on the use of massage therapy.

2. Formulate the evidence-based clinical practice instructions on massage therapy for oncology

patients.

3. Reduce pain and anxiety level through relaxing massage therapy over the body.

4. Provide a safe and cost-effective evidence-based practice for pain reduction and anxiety

relaxation.

61

Target Group

The protocol is to support nurses and other allied health staff to initiate and terminate the massage

therapy on cancer patients who have experienced pain or anxiety when admitted to day care center

or oncology wards in Hospital A. Nurses and allied health staff would perform the massage therapy.

However, only nurse can make the decision to initiate or terminate the massage therapy.

Inclusive criteria of the target patients:

1. Patients should be aged 18 or above.

2. Patients should be cognitively competent who should have GCS =15/15.

Exclusive criteria of the target group:

1. Patients who have any open wound over the body.

2. Patients who have any dermatitis.

3. Patients’ platelet count lower than 100,000/mm3.

4. Patients who have spinal cord injury.

5. Patients who have altered level of consciousness.

62

Recommendations

The levels of evidence were graded under the Scottish Intercollegiate Guidelines Network (SIGN,

2008). There are several grade of recommendation, grade A, B, C and D. Grade A recommendation

refer to there is a systematic review of RCTs or a body of evidence consisting principally of studies

rated as 1+ or there is at least one meta analysis, systematic, or RCT rated as 1++ and directly

applicable to the target population. Grade B of recommendation refers to a body of evidence

including studies rated as 2++. For details of Grade A to Grade D, please refer to Appendix J.

Recommendation 1

Assessment should be conducted by nurses so as to exclude any high risk group as listed in the

exclusion criteria from entering the massage program.

(Grade of recommendation: A )

Evidence:

Patients with certain medical problems, including low platelet count, altered level of consciousness,

dermatitis, spinal cord injury were excluded (Wang et al, 2014; Stringer, Swindell,Dennis, M, 2008;

Toth,et al, 2013; Mehling et al,2007) (1+, 1+,1-,1+). It is essential to exclude these conditions as

massage therapy may cause complications on the above patients such as neuropathy damage,

bleeding or even death.

63

Recommendation 2

Informed consent should be obtained from patients before any massage therapy.

(Grade of recommendation: A)

Evidence:

Not all of the oncology patients would like to have massage therapy. Some may have very negative

feelings towards massage or other body contact. Therefore, informed consent from patients is

necessary. All studies have obtained informed consent before any interventions. (Wang et al ,2014;

Stringer, Swindle and Dennis, 2008;, Toth et al,2013; Sendin et al,2012 and Mehling et al, 2007)

(1+, 1+, 1-, 1-, 1+)

Recommendation 3

Swedish Massage would be used as the method of massage therapy.

(Grade of recommendation: B)

Evidence:

Three studies use Swedish massage as the intervention method (Wang et al ,2014; Stringer, Swindle

and Dennis, 2008;, Toth et al,2013) (1+, 1+, 1-,).

64

Recommendation 4

The duration of massage therapy is recommended to be around 30 minutes, once per day and

two to three times per week, depending on the condition of patients and the time available of

massage therapists.

(Grade of recommendation: A)

Evidence:

Five of the reviewed studies showed that 15-30 minutes of massage therapy had significant effects

in reducing pain or anxiety level of oncology patients. (Wang et al ,2014; Stringer, Swindle and

Dennis, 2008;, Toth et al,2013; Sendin et al,2012 and Mehling et al, 2007) (1+, 1+, 1-, 1-, 1+)

Recommendation 5

Pain intensity level of each patient should be collected as baseline before the start of any

massage therapy intervention. Numeric rating scale (NRS) is the recommended scale.

(Grade of recommendation: B)

Evidence:

Numeric rating scale (NRS) in which zero represents symptom absent and 10 represents the worst

possible symptom. Three studies use NRS (Wang et al ,2014; Toth et al,2013; Mehling et al, 2007)

(1+,1-, 1+). .

Recommendation 6

Anxiety level of each patient should be collected as baseline before the start of any massage

therapy intervention. Numeric rating scale (NRS) is the recommended scale.

(Grade of recommendation:B)

Evidence:

Three studies use Numeric rating scale (NRS) to represents the anxiety level. (Wang et al ,2014;

Toth et al,2013; Mehling et al, 2007) (1+,1-, 1+). .

65

References

Mehling, W. E., Jacobs, B. & Acree, M. (2007). Symptom management with massage and

acupuncture in postoperative cancer patients: a randomised controlled trial . Journal of pain and

symptom management, 33 (3), 258-266.

Sendin L., Sedin, F. A. & Cleland, J. A. (2012). Effects of physical therapy on pain and mood in

patients with terminal cancer: a pilot randomised clinical trial. the journal of alternative and

complementary medicine, 18 (5), 480-486.




Stringer, J., Swindell, R. & Dennis, M. (2008). Massage in patients undergoing intensive

chemotherapy reduces serum cortisol and prolactin. Psycho-Oncology, 17 1024-1031.

Toth, M., Marcantonio, E. R. & Davis, R. B. (2013). Massage Therapy for patients with metastatic

cancer: A pilot Randomised controlled Trial. The journal of alternative and complementary

medicine, 19 (7), 650-656.

Wang, T. J., Wang, H. M. & Yang, T. S. (2015). The effect of abdominal massage in reducing

malignant ascites symptoms. Research in Nursing & Health, 38 51-59.


66

Appendix L : Assessment Form for massage treatment

Patient ID:_____________________

Pre and Post assessment form for massage treatment

Pain level before massage therapy NRS (0-10)

Pain level 30 minutes after massage

therapy NRS (0-10)

Pre and Post assessment form for massage treatment

Anxiety level before massage

therapy NRS (0-10)

Anxiety level 30 minutes after

massage therapy NRS (0-10)

67

Appendix M: Patient’s Questionnaire on Satisfaction towards Massage Therapy

Please choose the scale (5= total agree; 4=agree; 3=no comment; 2=disagree; 1= total disagree

1. I am satisfied with the massage therapy provided.

2. Massage therapy is useful in reducing pain level.

3. Massage therapy is useful in reducing anxiety level.

4. The hospital environment is comfortable for massage

therapy

5. I am satisfied with the staff who perform the massage

treatment

6. I would recommend the massage therapy to the others

who have experienced pain or anxiety from cancer

68

Appendix N: Staff Self-reported Questionnaire on the use of massage innovation

Please choose the scale (5= total agree; 4=agree; 3=no comment; 2=disagree; 1= total disagree

1. I am satisfied with the instruction and

recommendation of the guideline

2. Staff training is good and appropriate.

3. I have confident to perform massage therapy

4. The innovation has increased nursing autonomy

5. I am wiling to perform massage therapy to the

patients who are eligible for the massage intervention.

69

References

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cancer. JAMA, 279 (23), 1877-1882.

Billhult, A., Bergbon, I. & Stener-Victorin, S. (2007). Massage Relieves Nausea in Women with

Breast Cancer Who Are Undergoing Chemotherapy. The Journal of Alternative and

Complementary Medicine, 13(1), 53-57.

Cassileth, B. R. & Vickers, A. J. (2004). Massage therapy for symptom control: Outcome study at a

major cancer center. Journal of Pain and Symptom Management, 28 (3), 244-249.

Centre for Health Protection- Vital statistics (2015). Retrieved December 10, 2015 from Centre for

Health Protection, Web site: http://www.chp.gov.hk/en/data/4/10/27/117.html

Falkensteiner, M., Mantovan, F., Muller, I. & Them, C. (2011). The Use of Massage Therapy for

Reducing Pain, Anxiety, and Depression in Oncological Palliative Care Patients: A Narrative

Review of the Literature. International Scholarly Research Network (ISRN) Nursing, 1-8.

Gatlin, C.G. & Schulmeister, L. (2007).When Medication Is Not Enough: Nonpharmacologic

Management of Pain. Clinical Journal of Oncology Nursing, 11(5), 699-704.

Hong Kong Cancer Registery. (2014, November ). Hospital Authority

http://www.chp.gov.hk/en/data/4/10/27/117.html

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Kim YC, Moon H, Ahn JS, Minerva M, et al. Cancer pain management practices and their impact

on quality of life for Asian cancer patients. Abstract 6531. ASCO 2015: Annual Meeting of the

American Society of Clinical Oncology. May 29-June 2, 2015. Chicago, IL

Pandey, M., Sarita, G. P. & Devi, N. (2006). Distress, anxiety, and depression in cancer patients

undergoing chemotherapy. World Journal of Surgical Oncology, 4 (68), 1-5.

Saturon, P. J., Martinez-nicolas, I. & Robles-garcia, I. S. (2014). Development and pilot test of a

new set of good practice indicators for chronic cancer pain management. European Journal of Pain,

1 1-11.

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http://www.sign.ac.uk/methodology/checklists.html

Spooren, W. P., Vassout, A. & Neijt, H. C. (2000). Anxiolytic-Like Effects of the Prototypical

Metabotropic Glutamate Receptor 5 Antagonist 2-Methyl-6-(phenylethynyl)pyridine in Rodents.

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1267.

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(7219):1254-1257

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http://www.who.int/mediacentre/factsheets/fs297/en/

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