Copyright B 2013 Wolters Kluwer Health | Lippincott Williams amp Wilkins

K E Y W O R D S

Cancer treatments

Evidence-based practice

Healthcare delivery

HRQOL

Symptom management

TRSC

Phoebe D Williams PhD RN FAAN

Kathleen M Graham MS BSN RN APNP-BC AOCN CNS

Deborah L Storlie RN NC

Therese M Pedace BSN RN

Kurt V Haeflinger BS

David D Williams MPH

Diane Otte MS RN OCN

Jeff A Sloan PhD

Arthur R Williams PhD MA MPA

Therapy-Related Symptom Checklist Use During Treatments at a Cancer Center

Background Cancer treatment efficacy has improved with therapies at high or

sustained dosages However there is increasing concern about symptom

management and patientsrsquo quality of life Objective The objective of this study was

to assess whether use of a Therapy-Related Symptom Checklist (TRSC) with oncology

outpatients increases the number of symptoms documented and managed and

whether this improves patientsrsquo health-related quality of life (HRQOL) Methods This

was a sequential cohort trial Fifty-five oncology outpatients in treatment received

standard of care (group 1 G1) Afterward another 58 patients (group 2 G2)

received standard of care at the same clinic however these patients additionally

answered the TRSC immediately prior to each consultation The TRSC results were

then shared with clinicians Repeated measures (2Y11 visits) were obtained of the

number of patient treatment symptoms documented (medical records G1 and TRSC

G2) HRQOL and Karnofsky scores n = 696 observations (328 G1 and 368 G2)

The number of symptoms reported and HRQOL were covariate adjusted using

population averaged generalized estimating equations Results G2 patients had a

Author Affiliations School of Nursing University of Kansas Kansas City (Dr P D Williams) Mayo Clinic Health SystemYFranciscan Healthcare La Crosse Wisconsin (Mss Graham Storlie Pedace and Otte) Mayo Clinic Rochester Minnesota (Mr Haeflinger and Dr Sloan) Childrenrsquos Mercy Hospitals amp Clinics KansasCityMissouri (Mr Williams)Department of HealthPolicy andManagement College of Public Health University of South Florida Tampa (Dr A R Williams)

The Franciscan Skemp Foundation provided funding for the study con-sultations were provided by Thomas Grau MD health clinicians in the study were Paula Gill MD Dale Groshek PA-C Kiernan Minehan MD James Novotny MD FACP and Haleem Rasool MD FACP Velda J Gonzalez MSN RN PhD student School of Nursing University of Kansas literature review Carolyn D Spears administrative support Childrenrsquos Mercy Hospitals and Clinics Donna Dye administrative support Department of Health Policy and Management College of Public Health University of South Florida

The authors have no conflicts of interest to disclose

Author contributions Dr P D Williams rsquoconception and design data ac-quisition data analysis and interpretation and manuscript write-up Ms Graham conception and design data acquisition and manuscript write-up Ms Storlie nurse coordinator data acquisition and manuscript write-up Ms Pedace con-ception and design data acquisition and manuscript write-up Mr Haeflinger data acquisition analysis and interpretation and manuscript write-up Mr Williams data analysis and interpretation and manuscript write-up Ms Otte conception data acquisition and manuscript write-up Dr Sloan data analysis and write-up Dr A R Williams conception and design data acquisition data analysis and interpretation and manuscript write-up

Correspondence Phoebe D Williams PhD RN FAAN School of Nurs-ing University of Kansas 3901 Rainbow Blvd Mailstop 4043 Kansas City KS 66106 (pwilliamkumcedu)

Accepted for publication April 4 2012 DOI 101097NCC0b013e3182595406

TRSC Use During Treatments at a Cancer Center Cancer NursingTM Vol 36 No 3 2013 n 245

Copyright copy 2013 Lippincott Williams amp Wilkins Unauthorized reproduction of this article is prohibited

72 higher population averaged covariate-adjusted HRQOL than G1 patients

(33 more points on HRQOL P = 012) One hundred sixteen percent more

covariate- and nonYcovariate-adjusted symptoms were documentedmanaged

in G2 than G1 (614 symptoms vs 284 P G 0001) The HRQOL TRSC and

Karnofsky scores correlated r 9 040 Conclusion Use of patient-reported

TRSC improves symptom documentationmanagement and patient HRQOL

Implications for Practice Study findings were consistent with recent research

that has shown that use of checklists can have powerful influences on both

quality and safety of healthcare services and patient outcomes

As the efficacy of cancer treatment has improved more types of cancers are being treated with chemotherapy and radiotherapy at high or sustained dosages Consequently

there is increased concern about symptom documentation and management and patientsrsquo quality of life1Y10 Underdocumen-tation of symptoms during clinic visits had been reported9

Symptom Monitoring Symptom Management and Self-care Considerable information is available about the management of cancer treatmentYrelated symptoms but often assessment scales measure only a single or small set of symptoms Symp-toms studied have included nausea and vomiting11 taste change loss of appetite and weight loss12 sore mouthmucositis13 fa-tigue pain and depression1415 dyspnea16 and paresthesias17

A recent review concluded that pain is well studied but other symptoms need better understanding and assessment18 Although several multiple symptom scales have been developed1451920

and described in reviews3 considerably less studies have assessed multiple symptoms while healthcare is actually being deliv-ered2122 Multidisciplinary initiatives are underway to improve collection of patient-reported outcomes within clinical settings23Y25

Clinicians must rely on accurate patient-reported symptoms to manage treatment-related toxicities Complexity of regimens makes it more likely that patients will experience potentially toxic or disturbing adverse effects requiring prompt and effec-tive self-care Some cancer patients are successfully using self-care to complement medical and nursing care for symptom con-trol6Y81026Y29 Patients who participate in symptom monitor-ing are more satisfied and interact with providers more regarding

2829 symptom management Effective self-care is increasingly re-garded as a requisite of symptom management and adherence to treatment Approaches to symptom management and the deliv-ery of interventions consistent with and supportive of self-care include home care by trained nurses10 and clinic-based interven-tions designed to manage specific symptoms such as fatigue26

Health-Related Quality of Life Health-related quality of life (HRQOL) refers to a multidimen-sional construct that has physical mental social economic and spiritual domains30Y36 Several HRQOL scales specific to cancer have been developed including the HRQOL Linear Analogue Self-assessment (LASA) used in this study3738 The HRQOL-

LASA has been found to be robustly related to symptom oc-currence severity and patient functional status and easy to use in clinics3738 Health-related quality of life has been used as an outcome in chemotherapy radiation and surgery breast cancer neuro-oncology lung cancer advanced cancer and teleoncology133Y38

Design of Studies Increasing calls for translational research and study designs that better reflect real-world treatment conditions have led to interest in observational nonexperimental and quasi-experimental research These include calls by theNational Institutes ofHealth (PA-05-90) and articles by Black39 and others40 in the British Medical Journal Sequential cohort designs have been helpful to study interven-tions in settings in which the clinical environment itself is changed by the intervention or other circumstances do not permit ran-domized clinical trial (RCT)41 Even where systematic multisite trials may be feasible a single-site observational study can be helpful before proceeding to more costly designs40

Study Hypotheses Documentation of patient-reported symptoms management of symptoms and HRQOL can be improved through use of the Therapy-Related Symptom Checklist (TRSC) in clinic practice Study hypotheses are as follows

H1 A treatment cohort using the TRSC at clinic visits will show a statistically significant positive increase in HRQOL-LASA compared with a treatment cohort receiving standard of care

H2 A treatment cohort using the TRSC during clinic visits will show a statistically significant larger number of symptoms documented and managed compared with a treatment cohort receiving standard of care

These hypotheses are tested using a sequential cohort design and generalized estimating equations (GEEs)

n Methods

Study Design This is a quasi-experimental sequential cohort design with cy-clical turnover41Y44 This design is adequate to assess pre-post

246 n Cancer NursingTM Vol 36 No 3 2013 Williams et al

Copyright copy 2013 Lippincott Williams amp Wilkins Unauthorized reproduction of this article is prohibited

changes between control and intervention groups if there are minimal confounding historical changes adequate statistical con-trols and no changes in personnel or other treatment resources In this study G1 and G2 were treated within relatively narrow time frames mitigating time-related confounding Changes in the primary outcome (HRQOL) were adjusted using patient baseline measures and covariates discussed in the literature45

Total number of staff full-time equivalents remained constant throughout the study periods The practice model also remained unchanged throughout the study periods The study was ap-proved by the study sitersquos institutional review board

Participants Sample and Setting Randomization of patient assignment into treatment cohorts was impossible in this study because 1 outpatient clinic served the site and the intervention would itself alter the delivery of care within the clinic Use of the TRSC by patients and clinicians would lead to changes in interactions between them and among clinicians Data therefore were collected from 2 cohorts of pa-tients sequentially one cohort before use of the TRSC (G1) at the clinic and another during TRSC use (G2) Study patients were accrued as they were usually scheduled for treatment at the clinic during each observation period Eligible patients were invited to participate in the study and an institutional review boardYapproved informed consent was obtained Inclusion crit-eria required that study patients had at least 1 day of treatment (radiation chemotherapy or both) were not already participat-ing in an ongoing clinical trial had no diagnosed psychopathol-ogy were 18 years or older spokeread English because study forms were not available in other languages and had an Eastern Cooperative Oncology Group score of 3 or less or Karnofsky score of 60 or greater

The 2 study cohorts were accrued and followed to the end of each study period first G1 patients (March 6 2007 through November 23 2007) and later G2 patients (May 7 2008 through March 3 2009) Repeated measures were obtained from 55 patients in G1 and 58 patients in G2 up to and in-cluding a predesignated last date of data accrual for each cohort As a result of the accrual process the number of patient visits or observations ranged from 1 to 11 Two patients with only a single visit (1 each in G1 and G2) are excluded from analysis and discussion in this article There was no overlap between pa-tients in groups 1 and 2

Sample Size Equations in Twisk45 were used to estimate power and sample size for the primary study outcome the HRQOL-LASA total score An effect size = 030 = 05 5 repeated measures per subject and a desired power = 080 led to 55 subjects needing to be obtained from each of the 2 study cohorts (groups) or 110 subjects in total To allow for withdrawals losses to follow-up and incomplete data collection 64 subjects were actually accrued into each study group

Demographics of the 113 subjects used in this article appear in Table 1 Of the 128 subjects on whom data were collected 2 were excluded for having only 1 visit and 13 were not able

TRSC Use During Treatments at a Cancer Center

to be staged for their cancer Stage was considered a critical covariate in the 2 GEEs Exclusion of these subjects left 113 for the analysis in this article with 696 observations The mean number of observations per patient was 52

Setting The study oncology clinic is located in a small city in the US upper Midwest with population of 107 120 (2005) of which 96+ is white The county has 7 major manufacturing com-panies 1 state university 1 private university 1 technical college 2 integrated healthcare delivery systems and other employers in smaller manufacturing companies The median income of res-idents was $26 030 (75 of the statersquos median income) The other 10 counties in the tristate catchment area are similarly situated in terms of mix of economic activities with median incomes below medians in Wisconsin Minnesota and Iowa

The clinic is part of 1 integrated delivery system with 3 hos-pitals (total of 430+ beds) serving residents in the states men-tioned Cancer services include inpatient and outpatient care at a state-of-the-art Center for Advanced Medicine and Surgery which opened in 2004 in the city The physicians in the Division of HematologyOncology and Division of Radiation Oncology are all specialists in cancer care Medical school residency and fellowship experiences are from top schools in the United States all are board certified in their respective specialties including internal medicine medical oncology hematology and radiation oncology The nursing staff consists of highly qualified nurses the majority of whom are oncology certified Oncology patients also have access to a full set of support services at the clinic

Standard of Care Treatment options in the study clinic include chemotherapy and radiation therapy A wide array of support services is avail-able including assessment and referral for specialized individual and family counseling support groups education and resource materials referral to complementary therapies by patient request nutritional counseling social work services and financial assis-tance Documentation of symptoms and their management is done by physicians and nurses using the standard clinic interview and medical record Health-related quality of life is not docu-mented except when a patient is enrolled in an RCT that requires this Randomized clinical trials have been exclusively drug trials

Upon admission for treatment and outpatient follow-up pa-tients have the option of meeting with a personal cancer guide an experienced registered nurse The RN lsquolsquoCancer Guidersquorsquo helps the patient and a family member if present develop an individ-ualized plan of care that encompasses psychosocial emotional and spiritual needs Nationally recommended research-based clinical protocols are used for all cancer treatments

Intervention The first study cohort received standard care at the clinic Pa-tients were entered into the study during the first 4 months and followed up for a subsequent 4 months Data were col-lected from these patients using the HRQOL-LASA a short

Cancer NursingTM Vol 36 No 3 2013 n 247

Copyright copy 2013 Lippincott Williams amp Wilkins Unauthorized reproduction of this article is prohibited

Table 1 amp Demographics of Study Subjects

All Experimental (G2) Control (G1)

N = 113 n = 58 n = 55 Tests

Age Median=61 Median = 60 Median = 62 2 = 042 P = 51

Mean 6023 (SD 996) Mean 5824 (SD 914) Mean 6233 (SD 1049) z = 221 P = 03

N n n Pe

Gender Male 46 407 26 448 20 364 44

Female 67 593 32 552 35 636 Marital status Single 6 53 5 86 1 18 50

Married 89 788 43 741 46 836 Divorced 12 106 7 121 5 91 Widowed 3 26 1 17 2 36

Other 3 26 2 34 1 18 Education Less than high school 10 89 5 86 5 91 84

High school 31 273 14 241 17 309 High school+VOAA 53 469 28 483 25 454 BABS 10 89 5 86 5 91 Graduate school 9 80 6 103 3 55

Significant others No 21 186 13 224 8 146 34 Yes 92 814 45 776 47 854

Diagnosis Breast cancer 42 371 22 379 20 363 39 Prostate cancer 21 186 14 241 7 127

Lung cancer 14 124 6 103 8 146 Other 36 319 16 276 20 364

Stage

I 20 177 7 121 13 236 27 II 37 327 23 397 14 255 III 23 203 11 190 12 218 IV 33 292 17 292 16 291

RT No 32 283 15 259 17 309 68 Yes 81 717 43 741 38 691

CT No 31 274 19 328 12 219 21 Yes 82 726 39 672 43 781

Both (RT and CT) No 63 558 34 586 29 537 57 Yes 50 442 24 414 26 473

Abbreviations BABS bachelorrsquos of artsbachelorrsquos of science CT chemotherapy RT radiotherapy VOAA vocationalassociate in arts Note Except where specified statistical tests are exact tests of proportions or frequencies

demographic data form a symptom management record and TRSC was completed by patients prior to clinical consulta-Karnofsky scale and a medical record review by an experi- tion4Y6 The checklist was answered on a scale of 0 (none or enced RN46 Patients who received RT daily completed instru- no symptom) to 4 (very severe) The completed TRSC was ments once weekly on the same day each week Patients receiving provided to the clinicians for use or reference during the pa-chemotherapy completed the instruments on the day of pro- tient appointment vider evaluation prior to receiving chemotherapy on day 1 of Prior to the beginning of the study clinic staff were trained each cycle The number of radiation treatments and chemother- in the use of the study instruments and the importance of com-apy cycles varied depending on the treatment protocol The plete and consistent follow-up to accrue at least 5 complete study coordinator monitored and logged in subjectsrsquo schedules sets of instruments from each patient Before the beginning of

The second study cohort received the standard of care and accrual of the second or intervention study cohort clinic staff the same instruments were used In addition the 25-symptom was introduced to the TRSC and advised that on the patientsrsquo

248 n Cancer NursingTM Vol 36 No 3 2013 Williams et al

Copyright copy 2013 Lippincott Williams amp Wilkins Unauthorized reproduction of this article is prohibited

completion of the form the provider was to be given a copy No training was provided as to how this form was to be used with patients Patients were to be accrued as usual by the clinic

Study Variables and Instruments The study variables are shown in Chart 1 and instruments or measures used including the symptom documentation for the

Chart 1 amp Study Variables

1 Total HRQOL-LASA score This measure is briefly described

in Chart 2

2 Number of symptoms documented andmanaged (total number of symptoms) For G1 the number of symptoms managed and documented was a count of the number of symptoms

obtained from medical record review by a trained oncology nurse abstractor (see Chart 2) For G2 the number of symptoms documented and managed was a count of the symptoms reported on the completed TRSC For both G1 and

G2 the nurse examined medical records to validate symptom management One study hypothesis was that the number of symptoms documented and managed would be greater in G2

than in the standard-of-care group (G1) The TRSC is briefly described in Chart 2

The main study variable is

3 TRSC group placement (intervention group) is an indicator variable (G 1 = G2 0 = G1) The primary study hypothesis is that the parameter of this variable will be 90 with P e 05 with respect to HRQOL

The study covariates are 4 Baseline QOL is the HRQOL-LASA score measured at baseline (first visit after entry into the study)

5 Education level (education) is the level of education attained by the patient ranging from 1 = less than high school to 5 = graduate school

6 Age is age in years of the patient at entry to the study 7 Male is the gender of the patient M = 1 F = 0 8 Significant other is the presence of a significant other in

the household yes = 1 no = 0 9 Stage is the documented stage of the cancer upon entry to the study Stage is rank ordered from I to IV

10 Radiotherapy is an indicator variable (1 = yes 0 = no)

if radiotherapy was documented after entry into the study 11 Chemotherapy is an indicator variable (1 = yes 0 = no)

if chemotherapy was documented after entry into the study

By implication scores of 1 on both radiotherapy and chemotherapy indicate combined therapy

12Days from baseline entry into the study (time) is a cumulative

count of the number of days from entry into the study (time) to the day at which each set of observations is collected from each study patient

13 Interaction effects of days from baseline on group placement

is time group placement which is used to capture the combined effects of time and group placement The multiplication of independent variables in a regression equation is commonly

used to capture the effects of 2 or more variables together on a dependent variable thus the term interaction effects47

Abbreviations F female G1 group 1 G2 group 2 HRQOL-LASA Health-Related Quality of Life Linear Analogue Self-assessment M male QOL quality of life TRSC Therapy-Related Symptom Checklist

Chart 2 amp Study Instruments

1 The TRSC4Y827 is a patient self-report instrument that can

serve as both a guide (checklist) helpful to clinicians before and during patient consults and a subjective measure of therapy-related symptom severity of concern to patients

Each of the 25 symptoms on the TRSC is rated by patients using a 5-point scale 0 (not present) to 4 (very severe) Thus the total or summated TRSC score indicates both

symptom occurrence and severity Physical and psychological symptoms are included on the checklist Additional symptoms can be added to the checklist by patients using 5 blank spaces and rated for symptom severity Fewer than 2 of

patients seen in clinics or in studies have added symptoms to the checklist4Y827 Studies have reported good measurement properties of the TRSC The TRSC is simple

to administer in busy clinics and has been a clinically useful self-report checklist The summated TRSC score correlates well with health-related quality-of-life measures including

the Functional Assessment of Cancer TherapyYGeneral33

The TRSC captures patient symptom concerns of both radiotherapy and chemotherapy patients14Y8273348

2 HRQOL-LASA has 6 items that use a 10-point scale (0 lsquolsquoas bad as it can bersquorsquo 10 lsquolsquoas good as it can bersquorsquo) For example

using the past week as a point of reference a sample item is How would you describe lsquolsquoyour overall physical well-beingrsquorsquo Another item is lsquolsquoyour overall emotional well-beingrsquorsquo LASA

items have been validated as general measures of global QOL dimensional constructs in numerous settings including sites used by cancer patients33Y38 A high score on the

HRQOL-LASA indicates a high quality of life 3 Karnofsky PerformanceFunctional Status Scale46 was documented on the medical record by the physician or associate provider This scale rates the condition and activity

or functional status of the patient receiving cancer treatment Higher scores on this instrument indicate better functional status This scale has good measurement properties and is used

in clinical research including cancer research4Y8273348

4 Health Form On this form the study nurse coordinator based on the patientrsquos medical record documented the diagnosis type

and stage of cancer treatment start date treatment modality etc 5 Sociodemographic Form Demographic and other data included the respondentrsquos age gender marital status etc The form was completed once (at baseline) by the patient or a family member

6 Medical Record Review FormVSymptoms and Management In the study at the date of each patientrsquos oncology clinic visit recorded and documented symptoms

(and any symptom management provided) were listed on data collection forms as lsquolsquoSymptoms Recordedrsquorsquo and all corresponding lsquolsquoSymptom Management Recordedrsquorsquo

These data were entered later into the study database

Abbreviations HRQOL-LASA Health-Related Quality of Life Linear Analogue Self-assessment LASA linear analogue self-assessment QOL quality of life TRSC Therapy-Related Symptom Checklist Note At baseline and return visits the standard care (non-TRSC) cohort answered instruments 2Y5 instrument 6 was completed by a data collector The TRSC cohort answered instruments 1Y5 instrument 6 was completed by a data collector who was the same nurse who collected the data in G1

non-TRSC group in Chart 2 During G1 a trained oncology nurse abstracted the symptoms managed and documented after each clinic visit another nurse checked accuracy These data

TRSC Use During Treatments at a Cancer Center Cancer NursingTM Vol 36 No 3 2013 n 249

Copyright copy 2013 Lippincott Williams amp Wilkins Unauthorized reproduction of this article is prohibited

completion of the form the provider was to be given a copy No training was provided as to how this form was to be used with patients Patients were to be accrued as usual by the clinic

Study Variables and Instruments The study variables are shown in Chart 1 and instruments or measures used including the symptom documentation for the

Chart 1 amp Study Variables

1 Total HRQOL-LASA score This measure is briefly described

in Chart 2

2 Number of symptoms documented andmanaged (total number of symptoms) For G1 the number of symptoms managed and documented was a count of the number of symptoms

obtained from medical record review by a trained oncology nurse abstractor (see Chart 2) For G2 the number of symptoms documented and managed was a count of the symptoms reported on the completed TRSC For both G1 and

G2 the nurse examined medical records to validate symptom management One study hypothesis was that the number of symptoms documented and managed would be greater in G2

than in the standard-of-care group (G1) The TRSC is briefly described in Chart 2

The main study variable is

3 TRSC group placement (intervention group) is an indicator variable (G 1 = G2 0 = G1) The primary study hypothesis is that the parameter of this variable will be 90 with P e 05 with respect to HRQOL

The study covariates are 4 Baseline QOL is the HRQOL-LASA score measured at baseline (first visit after entry into the study)

5 Education level (education) is the level of education attained by the patient ranging from 1 = less than high school to 5 = graduate school

6 Age is age in years of the patient at entry to the study 7 Male is the gender of the patient M = 1 F = 0 8 Significant other is the presence of a significant other in

the household yes = 1 no = 0 9 Stage is the documented stage of the cancer upon entry to the study Stage is rank ordered from I to IV

10 Radiotherapy is an indicator variable (1 = yes 0 = no)

if radiotherapy was documented after entry into the study 11 Chemotherapy is an indicator variable (1 = yes 0 = no)

if chemotherapy was documented after entry into the study

By implication scores of 1 on both radiotherapy and chemotherapy indicate combined therapy

12Days from baseline entry into the study (time) is a cumulative

count of the number of days from entry into the study (time) to the day at which each set of observations is collected from each study patient

13 Interaction effects of days from baseline on group placement

is time group placement which is used to capture the combined effects of time and group placement The multiplication of independent variables in a regression equation is commonly

used to capture the effects of 2 or more variables together on a dependent variable thus the term interaction effects47

Abbreviations F female G1 group 1 G2 group 2 HRQOL-LASA Health-Related Quality of Life Linear Analogue Self-assessment M male QOL quality of life TRSC Therapy-Related Symptom Checklist

Chart 2 amp Study Instruments

1 The TRSC4Y827 is a patient self-report instrument that can

serve as both a guide (checklist) helpful to clinicians before and during patient consults and a subjective measure of therapy-related symptom severity of concern to patients

Each of the 25 symptoms on the TRSC is rated by patients using a 5-point scale 0 (not present) to 4 (very severe) Thus the total or summated TRSC score indicates both

symptom occurrence and severity Physical and psychological symptoms are included on the checklist Additional symptoms can be added to the checklist by patients using 5 blank spaces and rated for symptom severity Fewer than 2 of

patients seen in clinics or in studies have added symptoms to the checklist4Y827 Studies have reported good measurement properties of the TRSC The TRSC is simple

to administer in busy clinics and has been a clinically useful self-report checklist The summated TRSC score correlates well with health-related quality-of-life measures including

the Functional Assessment of Cancer TherapyYGeneral33

The TRSC captures patient symptom concerns of both radiotherapy and chemotherapy patients14Y8273348

2 HRQOL-LASA has 6 items that use a 10-point scale (0 lsquolsquoas bad as it can bersquorsquo 10 lsquolsquoas good as it can bersquorsquo) For example

using the past week as a point of reference a sample item is How would you describe lsquolsquoyour overall physical well-beingrsquorsquo Another item is lsquolsquoyour overall emotional well-beingrsquorsquo LASA

items have been validated as general measures of global QOL dimensional constructs in numerous settings including sites used by cancer patients33Y38 A high score on the

HRQOL-LASA indicates a high quality of life 3 Karnofsky PerformanceFunctional Status Scale46 was documented on the medical record by the physician or associate provider This scale rates the condition and activity

or functional status of the patient receiving cancer treatment Higher scores on this instrument indicate better functional status This scale has good measurement properties and is used

in clinical research including cancer research4Y8273348

4 Health Form On this form the study nurse coordinator based on the patientrsquos medical record documented the diagnosis type

and stage of cancer treatment start date treatment modality etc 5 Sociodemographic Form Demographic and other data included the respondentrsquos age gender marital status etc The form was completed once (at baseline) by the patient or a family member

6 Medical Record Review FormVSymptoms and Management In the study at the date of each patientrsquos oncology clinic visit recorded and documented symptoms

(and any symptom management provided) were listed on data collection forms as lsquolsquoSymptoms Recordedrsquorsquo and all corresponding lsquolsquoSymptom Management Recordedrsquorsquo

These data were entered later into the study database

Abbreviations HRQOL-LASA Health-Related Quality of Life Linear Analogue Self-assessment LASA linear analogue self-assessment QOL quality of life TRSC Therapy-Related Symptom Checklist Note At baseline and return visits the standard care (non-TRSC) cohort answered instruments 2Y5 instrument 6 was completed by a data collector The TRSC cohort answered instruments 1Y5 instrument 6 was completed by a data collector who was the same nurse who collected the data in G1

non-TRSC group in Chart 2 During G1 a trained oncology nurse abstracted the symptoms managed and documented after each clinic visit another nurse checked accuracy These data

TRSC Use During Treatments at a Cancer Center Cancer NursingTM Vol 36 No 3 2013 n 249

Copyright copy 2013 Lippincott Williams amp Wilkins Unauthorized reproduction of this article is prohibited

were then entered as string variables into a computer database On a regular basis these data were checked by the data ana-lyst the principal investigators and consultants to the study and members of the research team

All instruments used have good psychometric properties including the TRSC4Y927 The major outcome measure is the HRQOL-LASA3738 The TRSC is shown in the Appendix

Data Analysis A statistician not involved in the collection and review of data conducted the statistical analysis Stata version 110 was used for all analyses49 The Stata routines are adjusted for censoring and semirobust SEs were obtained Only subjects with 2 or more clinic visits and documented stage were retained in the analysis

The first study hypothesis was examined using the HRQOL measures in a panel analysis specifically a population averaged GEE with a Gaussian distribution identity link and exchange-able correlation matrix Health-related quality of life was mea-sured during visits 1 to 11 The first observation of HRQOL was used as a baseline covariate in the GEE Because of the use of an HRQOL baseline the final analysis was done with 583 observations of 113 subjects The key study variable was group placement Covariates in addition to the baseline HRQOL were education level attained by the respondent age in years gender whether a significant other is in household stage ra-diotherapy chemotherapy and by implication combined treat-ment if radiotherapy = 1 and chemotherapy = 1 Time measured as days postbaseline was also included as a covariate This equa-tion was tested for interaction effects among the independent variables and none were found

The second study hypothesis was examined using a similar GEE however the dependent variable was total number of reported symptoms at each clinic visit (1Y11 [mean 52 visits per patient]) This analysis was done with 113 subjects and 696 observations Covariates were those mentioned previously plus an interaction effect measured as days from baseline mul-tiplied by group placement this variable is used to capture the combined effects of time and group placement The multi-plication of independent variables in a regression equation is commonly used to capture the effects of 2 or more variables acting together on a dependent variable thus the term in-teraction effects47

n Results

Participants Sociodemographic and Clinical Characteristics As Table 1 shows the only statistically significant baseline difference between subjects in G1 and G2 was age At group means G1 subjects on average were 409 years older than those in G2 (P = 03) however there is no statistically sig-nificant difference in median age The GEE equations used in this study are age adjusted Comparisons also were done

(not shown here) of demographics between the 696 observa-tions with results similar to those in Table 1

Outcome Data Main Results Primary Outcomes

As noted previously the primary study hypothesis was the ef-fect of TRSC group (G2) assignment on patients The results of the GEE used to measure this effect are shown in Table 2

As anticipated the largest single effect on HRQOL was the baseline HRQOL covariate Placement in the TRSC group raised quality of life on average by 331 points A 3-point change on this measure is considered clinically significant Male gender was associated on average with a lowered quality of life of 324 points None of the other covariates were statistically significant

Secondary Outcomes

An outcome of secondary interest was the effect of TRSC group placement on the number of symptoms identified and managed Generalized estimating equation results are shown in Table 3

Placement in the TRSC group (G2) had a strong effect on the number of symptoms documented andmanaged (P G 001) The number of symptoms documented and managed was on average 376 more than in G1 Stage also had an effect on the number of symptoms reported The number of symptoms doc-umented and managed increased by 076 for each stage greater than stage I the reference stage (P G 03) The interaction be-tween TRSC group placement and the number of days post-baseline was strong with the number of symptoms declining on average about 0015 each day postbaseline in G2 In sum-mary a greater number of symptoms was identified and man-aged in G2 than in the standard-of-care cohort and in G2 the number of symptoms declined by about 15 every 100 days postbaseline more than in the standard-of-care cohort

Table 2 amp Results of Generalized Estimating Equations Analysis of Health-Related Quality of Life Linear Analogue Self-assessment on Covariates

Variable Name Coefficient SE P

Constant 167528 77564 031 Baseline QOL 07083 00829 G001 Intervention group 33144 13152 012 Education j08092 07233 263 Age 00090 00673 893 Male j32381 15391 035

Significant other 01893 15507 903 Stage 06205 07723 422 Radiotherapy j26490 15413 086

Chemotherapy j36356 23372 120 Time j00166 00109 129

Abbreviation QOL quality of life Linear generalized estimating equation Response total HRQOL-LASA score Correlation exchangeable No of observations 583 scale parameter 623707 no of iterations 4 Estimate of common correlation 06095 Refer to Chart 1 for definitions of study variables

250 n Cancer NursingTM Vol 36 No 3 2013 Williams et al

Copyright copy 2013 Lippincott Williams amp Wilkins Unauthorized reproduction of this article is prohibited

Table 3 amp Results of Generalized Estimating Equations Analysis of Total Symptoms Identified and Managed on Covariates

Variable Name Coefficient SE P

Constant 25747 22991 263 Intervention group 37597 05939 G001 Education j01588 02531 344 Age j00310 00328 893 Male j07299 06698 276

Significant other 00226 06699 973 Stage 07590 03482 029 Radiotherapy 00767 04155 853

Chemotherapy 12776 06814 061 Time 00005 00031 870 Interaction j00151 00072 037

Linear generalized estimating equation Response total number of symptoms Correlation exchangeable No of observations 696 scale parameter 135982 no of iterations 5 Estimate of common correlation 06977 Refer to Chart 1 for definitions of study variables

Other Outcomes of Clinical Interest As in earlier studies4Y827334850 the TRSC total scores the HRQOL-LASA and Karnofsky all correlated significantly (P G 001) and in the expected directions The Pearson cor-relations between the Karnofsky HRQOL and total TRSC score in the current study were 042 and j047 respectively and between the HRQOL and TRSC j047 The correla-tion between the total TRSC score and the total number of symptoms reported was 074 which suggests that the number of symptoms reported by patients on the TRSC may capture both frequency and intensity

Additionally it should be noted that fewer than 2 of patients seen have added symptoms to the checklist although 5 blank spaces are available to do so4Y827334850Y52 Physical and psychological symptoms are included in the TRSC The 25 symptoms on the TRSC are as follows taste change loss of appetite nausea vomiting weight loss sore mouth cough sore throat difficulty swallowing jaw pain shortness of breath numbness of fingerstoes feeling sluggish depression difficulty concentrating fever bruising bleeding hair loss skin changes soreness in vein where chemotherapy was given difficulty sleep-ing pain decreased interest in sexual activity constipation Con-sistent with the literature4Y927334850Y52 among the most frequently occurring and severe symptoms marked on the TRSC and reported as being managed were loss of appetite and nausea

n Discussion Implications and Conclusions

The findings of this study are important Health-Related Quality of Life LASA increased by both a statistically sig-nificant and clinically significant amount when the TRSC was

used in the clinic setting Additionally although the study find-ings show that the number of symptoms identified and man-aged increased when the TRSC was implemented symptom scores decreased significantly over time in the TRSC cohort Although this study did not directly investigate the degree to which HRQOL improved because of better identification and management of patient symptoms it is likely that this accounts for a considerable proportion of the better outcomes in the TRSC group

The HRQOL and symptom findings are consistent with earlier studies by 2 of the authors that have shown that symp-toms of concern to patients are greatly underdocumented in medical records and in the standard clinic interview The de-velopment of the TRSC which began in 198413Y927 pre-ceded recent efforts by clinicians and researchers that urge use of checklists and other tools to obtain consistent clinically relevant information about patient perceptions concerns and preferences Moreover patients who participated in symptom monitoring using the TRSC are satisfied and interact with pro-

3351 viders more regarding symptom management As noted the TRSC includes physical and psychological symptoms The TRSC correlates with HRQOL measures including the Func-tional Assessment of Cancer TherapyYGeneral33 Use of the TRSC as in this study can be extended to address a number of recent interests including more systematic study of patient-reported outcomes53

This study has some limitations An RCT might follow this study but an RCT would require a large number of partici-pating clinics and patients and could be rather costly A sig-nificant limitation is the lack of minority representation due to population demographics at the study site This study how-ever at the least suggests that a working-class lower-middle-income population can benefit from TRSC use This is a large population that has been hard pressed by economic change in the United States and in the community used in this study The TRSC might produce similar results in different populations but this might require adjustments in how it is used and clinical services are delivered Two of the authors of this study and others have research completed and underway that has included African Americans Hispanics in the United States and patients in Puerto Rico485052 as well as completed studies in Asia7827

Implications Unlike many tools purported to be usable in clinics the TRSC was developed to address a specific clinical need the under-documentation of a wide array of symptoms of concern to patients receiving treatment for cancer Later studies have found that subscales of clinical interest are measured on this instru-ment and that the instrument has desirable psychometric prop-erties that were not anticipated when this checklist was developed14Y92733 The TRSC is easy to answer and can be completed quickly in clinic settings The TRSC was devel-oped from the bottom-up to meet patient and clinician needs9

and the results of this study and others indicate that this tool works well in clinic settings patient-centered care and evidence-based practice4850Y525455

TRSC Use During Treatments at a Cancer Center Cancer NursingTM Vol 36 No 3 2013 n 251

Copyright copy 2013 Lippincott Williams amp Wilkins Unauthorized reproduction of this article is prohibited

Recent research has suggested that the use of checklists can have a powerful influence on both the quality and safety of healthcare services and patient outcomes The findings of this study are very consistent with such a lsquolsquochecklist manifestorsquorsquo56 and even suggest that during cancer treatment improved patient outcomes arise from better symptom management and symp-tom reduction as a consequence of checklist use by clinicians A newly calibrated TRSC checklist for children (TRSC-C) is published in 2012 in Cancer Nursing57 The TRSC-C uses child-friendly terms for each symptom

In conclusion use of the patient-friendly TRSC by patients and clinicians in a cancer clinic improves symptom documen-tation and management and patient HRQOL Systematic use of checklists can have significant positive influences on the qual-ity and safety of patient treatments and outcomes especially if these tools can be easily completed in clinics without burdening patients and clinicians133515258

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TRSC Use During Treatments at a Cancer Center Cancer NursingTM Vol 36 No 3 2013 n 253

Copyright copy 2013 Lippincott Williams amp Wilkins Unauthorized reproduction of this article is prohibited

Appendix

254 n Cancer NursingTM Vol 36 No 3 2013 Williams et al

Copyright copy 2013 Lippincott Williams amp Wilkins Unauthorized reproduction of this article is prohibited

Appendix

254 n Cancer NursingTM Vol 36 No 3 2013 Williams et al

Copyright copy 2013 Lippincott Williams amp Wilkins Unauthorized reproduction of this article is prohibited