SCORE: A RANDOMISED CONTROLLED TRIAL EXAMINING … · SCORE DESIGN • A randomised controlled...
Transcript of SCORE: A RANDOMISED CONTROLLED TRIAL EXAMINING … · SCORE DESIGN • A randomised controlled...
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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
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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
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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
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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
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SCORE
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
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SCORE
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
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SCORE
• 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
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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
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Fig.2 Schedule of appointments and assessment. CEA Carcinoembryonic antigen, CT Computed tomography, PCP Primary care physician
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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)
Completed 6-month follow up (n=46)
Completed 9-month follow up (n=44)
Completed 12-month follow up (n=42)
Completed 3-month follow up (n=46)
Completed 6-month follow up (n=44)
Completed 9-month follow up (n=44)
Completed 12-month follow up (n=41)
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)
Lost to follow up (n=5)
Deceased (n=4)
Shared Care (n=47) Usual Care (n=47)
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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)
Completed 6-month follow up (n=46)
Completed 9-month follow up (n=44)
Completed 12-month follow up (n=42)
Completed 3-month follow up (n=46)
Completed 6-month follow up (n=44)
Completed 9-month follow up (n=44)
Completed 12-month follow up (n=41)
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)
Lost to follow up (n=5)
Deceased (n=4)
Shared Care (n=47) Usual Care (n=47)
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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)
Completed 6-month follow up (n=46)
Completed 9-month follow up (n=44)
Completed 12-month follow up (n=42)
Completed 3-month follow up (n=46)
Completed 6-month follow up (n=44)
Completed 9-month follow up (n=44)
Completed 12-month follow up (n=41)
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)
Lost to follow up (n=5)
Deceased (n=4)
Shared Care (n=47) Usual Care (n=47)
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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)
Completed 6-month follow up (n=46)
Completed 9-month follow up (n=44)
Completed 12-month follow up (n=42)
Completed 3-month follow up (n=46)
Completed 6-month follow up (n=44)
Completed 9-month follow up (n=44)
Completed 12-month follow up (n=41)
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)
Lost to follow up (n=5)
Deceased (n=4)
Shared Care (n=47) Usual Care (n=47)
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SCORE
• 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
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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
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