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

84 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 .