score: a randomised controlled trial examining … · score design • a randomised controlled...

Prof Michael Jefford Australian Cancer Survivorship Centre,

Peter MacCallum Cancer Centre

SCORE: A RANDOMISED CONTROLLED TRIAL EXAMINING

SHARED CARE (ONCOLOGY / GENERAL PRACTICE) FOR COLORECTAL SURVIVORS

Michael Jefford, Jon Emery, Andrew Martin, Richard De Abreu Lourenco, Eva Grunfeld, Mustafa Mohamed, Karolina Lisy, Dorothy King, Margaret Lee, Jo Phipps-Nelson, Paula Rodger, Ashkan Mehrnejad, Alexander Heriot, Jeanne Tie, Lisa Guccione, Niall Tebbutt,

Adele Burgess, Ian Faragher, Rodney Woods, and Penelope Schofield

SCORE: A randomised controlled trial examining shared care (oncology/general practice) for

survivors of colorectal cancer

INTRODUCTION

• Survivors of colorectal cancer (CRC) may experience a range of physical and psychosocial consequences from CRC and treatments

• Current follow up care is usually specialist-led (CR surgeon, oncologist)

Current care does not meet recommendations for comprehensive survivorship care

• Optimal management should harness the expertise of both primary care and oncology specialists

INTRODUCTION

• The ProCare study examined shared care for men with prostate cancer, and found

• Similar levels of distress, QOL, satisfaction

• Shared care was preferred by people who had experienced it

• Shared care was cheaper than standard care

DESIGN

• A randomised controlled trial

• 1:1 allocation to standard hospital-based specialist-led follow up or to shared follow up care between the patient’s hospital specialist and their GP

HYPOTHESIS

• Shared care will be an acceptable model of follow up with the potential to address care needs more efficiently than standard care

OUTCOMES

• Primary – Overall QOL at 12 months using the EORTC QLQ C30

• Secondary – individual aspects of QOL, unmet needs, continuity of care, satisfaction, costs / resource use

ELIGIBILITY

• Stage I-III CRC treated with curative intent

• Patients aged > 18 years

• Able to understand English

• GP willing to be involved

INTERVENTION INCLUDES

• Survivorship care plan for patient and GP

• Booklet and DVD for patient, common issues checklist

• Management guidelines for GP

• Reminders of GP appointments

• First stage of the study • Was intended to demonstrate acceptability, feasibility of study

procedures

• Was undertaken to confirm absence of harm from the intervention

• Aimed to recruit 100 patients

• Was funded by the Victorian Cancer Agency ($300 000)

• If the first phase was successful, plan to proceed to a definitive phase III, non-inferiority study

Fig.1 Flow diagram of patient recruitment and study conduct. CEA Carcinoembryonic antigen, CRC Colorectal cancer, CT Computed tomography, EOT End of treatment, PCP Primary care physician

Fig.2 Schedule of appointments and assessment. CEA Carcinoembryonic antigen, CT Computed tomography, PCP Primary care physician

Attachment 1: SCORE VCA Flow Chart s

Total Allocated (n=94)

Total Withdrawn (n=11)

3-month n=92

6-month n=90

9-month n=88

12-month n=83

Total Completed follow up

Assessed for eligibility (n=1576)

Withdrawn (n=5)

recurrence (n=5)

- 1 prior to 3M

- 2 prior 9M

- 2 prior to 12M

Withdrawn (n=6)

Patient withdrew (n=1)

- 1 prior to 3M

recurrence (n=5)

- 2 prior to 6M

- 3 prior to 12M

Completed 3-month follow up (n=46)

3-Month CEA 91%

9-Month CEA 93.3%

3-Month CEA 70%

9-Month CEA 77%

Follow-Up

CEA Reporting

Excluded (n=1288)

Not meeting inclusion/exclusion criteria

Not Stage I-III CRC (n=639)

Completed treatment +3 months (n=378)

CRC but no English (n=116)

CRC but treated for previous cancer (n=124)

CRC but psychological disorder (n=24)

GP currently participating (n=14)

Randomized (n=94)

Consented (n=108)

Did not receive allocated intervention (n=14)

GP refused participation (n=6)

Lost to follow up (n=4)

Patient Withdrew (n=4)

- Waiting end-treatment approach (n=60)

(Beyond the SEP-30 deadline)

- Waiting end-treatment (n=0)

- Waiting randomisation (n=0)

- Waiting GP consent (n=0)

Eligible patients (n=288)

Excluded (n=120)

Declined participation (n=35)

Clinician advised (n=28)

Treatment/Follow up transferred (n=48)

Deceased (n=4)

Shared Care (n=47) Usual Care (n=47)

3-month n=92

6-month n=90

9-month n=88

12-month n=83

Withdrawn (n=5)

recurrence (n=5)

- 1 prior to 3M

- 2 prior 9M

- 2 prior to 12M

Withdrawn (n=6)

- 1 prior to 3M

recurrence (n=5)

- 2 prior to 6M

- 3 prior to 12M

3-Month CEA 91%

9-Month CEA 93.3%

3-Month CEA 70%

9-Month CEA 77%

Follow-Up

CEA Reporting

Excluded (n=1288)

Randomized (n=94)

Consented (n=108)

Excluded (n=120)

Deceased (n=4)

3-month n=92

6-month n=90

9-month n=88

12-month n=83

Withdrawn (n=5)

recurrence (n=5)

- 1 prior to 3M

- 2 prior 9M

- 2 prior to 12M

Withdrawn (n=6)

- 1 prior to 3M

recurrence (n=5)

- 2 prior to 6M

- 3 prior to 12M

3-Month CEA 91%

9-Month CEA 93.3%

3-Month CEA 70%

9-Month CEA 77%

Follow-Up

CEA Reporting

Excluded (n=1288)

Randomized (n=94)

Consented (n=108)

Excluded (n=120)

Deceased (n=4)

3-month n=92

6-month n=90

9-month n=88

12-month n=83

Withdrawn (n=5)

recurrence (n=5)

- 1 prior to 3M

- 2 prior 9M

- 2 prior to 12M

Withdrawn (n=6)

- 1 prior to 3M

recurrence (n=5)

- 2 prior to 6M

- 3 prior to 12M

3-Month CEA 91%

9-Month CEA 93.3%

3-Month CEA 70%

9-Month CEA 77%

Follow-Up

CEA Reporting

Excluded (n=1288)

Randomized (n=94)

Consented (n=108)

Excluded (n=120)

Deceased (n=4)

• Acceptable to participants

• Few GPs opted out (only 6 declined participation)

• Very high retention at 6 and 12 months

• GPs completed recommended testing

• Independent, blinded statistical analysis has confirmed absence of significant harm from the intervention arm

• Further funding from Cancer Australia to complete a 200 patient phase III trial

THANK YOU

• The first phase of SCORE was funded by the Victorian Cancer Agency

• The second phase is funded by Cancer Australia

• Thank you to all patients who have been involved in the study

• Thank you to participating GPs and oncology clinical staff

• Thank you to the research team, particularly Mustafa, Ash and Paula

Send your question via Slido

https://www.sli.do/

Event code: # VCSC20

Questions?

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