SCORE: A multisite randomised controlled trial evaluating shared care for colorectal cancer survivors.

Authors

Michael Jefford

Michael Jefford

Peter MacCallum Cancer Centre, Melbourne, VIC, Australia;

Michael Jefford , Jon D. Emery , Andrew James Martin , Richard De Abreu Lourenco , Karolina Lisy , Mustafa Abdi Mohamed , Dorothy King , Niall C. Tebbutt , Margaret Lee , Ashkan Mehrnejad , Adele Burgess , Julie Marker , Renee Eggins , Joseph Carrello , Penelope Schofield

Organizations

Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; , Department of General Practice and Centre for Cancer Research, University of Melbourne, Melbourne, VIC, Australia; , NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia; , Centre for Health Economics Research and Evaluation, University of Technology Sydney, Sydney, Australia; , Peter MacCallum Cancer Centre, Melbourne, Australia; , Department of Medical Oncology, Olivia Newton-John Cancer, Wellness and Research Centre, Austin Health, Heidelberg, VIC, Australia; , Eastern Health, Western Health, Walter and Eliza Hall Institute of Medical Research, Melbourne, VIC, Australia; , Austin Health, Melbourne, Australia; , Primary Care Collaborative Cancer Clinical Trials Group, Melbourne, Australia; , NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia; , University of Technology Sydney, Sydney, Australia; , Swinburne University of Technology, Melbourne, Australia;

Research Funding

Other Government Agency
Cancer Australia and the Victorian Cancer Agency

Background: Colorectal cancer (CRC) survivorship is rising. Few studies have considered shared follow up (FU) care (SC) between oncologists and primary care providers (PCPs). SCORE is the first large RCT of SC for CRC survivors. Aim: to compare SC with usual care (UC) for CRC survivors. Primary objective: assess the effect of SC vs UC on the EORTC QLQ-C30 Global Health Status/Quality of Life (GHQ-QoL) scale to 12 months (mo). Secondary objectives: assess the effect of SC vs UC on QoL; pt perceptions of care; costs; clinical care processes (CEA tests, recurrences); and feasibility (recruitment, completion rate). Methods: Pts had stage I-III CRC, completed all treatments within 3 mo, spoke English, had a PCP, and no prior cancer. After pt consent, PCP could opt out. Pts were randomised 1 to 1 to SC or UC. SC replaced 2 routine oncologist visits with PCP visits and included a survivorship care plan, concerns checklist and management guidelines for the PCP. PCPs were asked to request CEA tests at 3 and 9 mo visits. Pts completed measures at baseline (BL) and at 6 and 12 mo FU. An estimate of the difference (diff) between groups on GHQ-QoL to 12 mo was obtained from a mixed model for repeated measures (MMRM). The test of non-inferiority was performed by evaluating the lower limit of the two-sided 95% confidence interval (CI) for the estimated diff (SC–UC) against a pre-specified non-inferiority margin (NIM) of -10 points. All randomised pts with available data were included in the primary analysis. Per-protocol population (PPP) comprised all randomised pts with ≥ 1 post-BL questionnaire (6 +/or 12 mo) and, for SC, ≥ 1 of the PCP visits. Results: 150 pts were randomised to SC (N=74) or UC (N=76); 11 PCPs declined. Median age 63 years, 39% women, 24% had radiotherapy. Primary: colon (59%), rectum (32%), overlapping (9%). 138/150 (92%) had BL and ≥1 post-BL GHQ-QoL score. 65/74 (88%) of SC pts attended 3- and/or 9-mo PCP visit. The mean (SD) GHQ-QoL scores at baseline / 6 mo / 12 mo were: 69 (18.7) / 69 (21.2) / 72 (20.2) for SC versus 68 (20.0) / 73 (15.1) / 73 (17.2) for UC. The MMRM mean estimate of GHQ-QoL across the 6 mo and 12 mo FU was 69 for SC and 73 for UC, mean diff -4.0 (95% CI: -9.0 to 0.9). The lower limit of the 95% CI did not cross the NIM. For the PPP (N=130/150), mean diff was -5.0 (95% CI: -10.1 to 0.2). No clear evidence of between group diffs on other C30 scales (accounting for multiplicity). At 12 mo, most popular preferences for FU were: SC for 40/63 (63%) in the SC group, similar preferences for SC 22/62 (35%) and ‘Hospital-based care with the doctors that treated the cancer’ 22/62 (35%) in UC. CEA completion was 89% at 3 and 83% at 9 mo in SC; 63% and 68% in UC. 5 recurrences in SC and 6 in UC arms. Conclusions: SCORE was highly feasible with high participation and retention, few PCPs declined. Compared to UC, pts having SC had non-inferior QoL. Adherence to CEA testing was higher in SC. Pts exposed to SC prefer this model of FU. Cost and implementation analyses will follow. Clinical trial information: ACTRN12617000004369.

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Abstract Details

Meeting

2023 ASCO Gastrointestinal Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session C: Cancers of the Colon, Rectum, and Anus

Track

Colorectal Cancer,Anal Cancer

Sub Track

Quality of Care/Quality Improvement

Clinical Trial Registration Number

ACTRN12617000004369

Citation

J Clin Oncol 41, 2023 (suppl 4; abstr 84)

DOI

10.1200/JCO.2023.41.4_suppl.84

Abstract #

84

Poster Bd #

E1

Abstract Disclosures

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