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

Abstract

1505 Background: 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 survivors of colorectal cancer (CRC). Primary objective: compare SC vs UC on the EORTC QLQ-C30 Global Health Status/Quality of Life (GHQ-QoL) scale to 12 months (mo). Secondary objectives: compare SC vs UC on QoL; patient (pt) perceptions of care; costs and clinical care processes (CEA tests, recurrences). Methods: Pts had completed treatment for stage I-III CRC within 3 mo, had a PCP, and no prior cancer. After pt consent, PCPs could opt out. SC replaced 2 routine oncologist visits with PCP visits and included a survivorship care plan, concerns checklist and PCP management guidelines. PCPs were asked to request CEA tests at 3 and 9 mo visits. Assessments were at baseline (BL), 6 and 12 mo FU. Difference (diff) between groups on GHQ-QoL to 12 mo estimated from a mixed model for repeated measures (MMRM). Non-inferiority evaluated by comparing the lower limit of the two-sided 95% confidence interval (CI) for the estimated diff (SC–UC) against a non-inferiority margin (NIM) of -10 points. Per-protocol population (PPP) comprised all randomised pts with ≥ 1 post-BL questionnaire (6 +/or 12mo) and, for SC, ≥ 1 of the PCP visits. Results: 150 pts were randomised to SC (N=74) or UC (N=76); 11 PCPs had declined. Median age 63 years, 39% women, 24% had radiation. Primary site: 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 visits. 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 differences on other QoL, unmet needs or satisfaction scales (C30, CR29, SUNS, PSQ), accounting for multiplicity. At 12 mo, more patients in SC (40/62, 65%) vs UC (24/58, 41%) felt their PCP was sufficiently knowledgeable (AOPSS). 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 mo and 83% at 9 mo in SC; 63% and 68% in UC. 5 recurrences in SC and 6 in UC arms. Pts in SC on average incurred A$456 less in health costs vs UC pts. Conclusions: SCORE had high PCP participation and pt retention. Compared to UC, pts having SC had non-inferior QoL, and lower costs. Adherence to CEA testing was higher in SC. Pts exposed to SC prefer this model of FU. Clinical trial information: ACTRN12617000004369 .