A randomized controlled trial (RCT) of a supportive care package (SurvivorCare, SC) for survivors of colorectal cancer (CRC).

Abstract

79 Background: Colorectal cancer (CRC) and its treatments can cause distressing short and long-term side effects as well as significant functional consequences. Current models of follow-up do not adequately address these issues. We conducted a multi-center RCT of an innovative program (SurvivorCare (SC)); designed to have a beneficial effect on psychological distress, supportive care needs (SCN) and quality of life (QOL). Methods: At the end of active treatment for stage I-III CRC, eligible patients ( =18 years, adequate English) were randomized 1:1 to usual care (UC) or to UC+SC. SC comprised educational materials, needs assessment, an individualized survivorship care plan, nurse-led end-of-treatment session and three follow up (FU) phone calls. Distress (BSI-18), SCN (CaSUN) and QOL (EORTC QLQ-C30, CR29) were assessed at baseline, 2 (FU1) and 6 (FU2) months. Primary hypothesis: SC would have a beneficial effect on distress at FU1. Secondary hypotheses: SC would have a beneficial effect on (1) SCN and QOL at FU1; and (2) distress, SCN and QOL at FU2. 15 items assessed satisfaction with survivorship care. Sample size of 180 (90/arm) was based on 80% power, 2-sided alpha of 0.05, to detect a between groups difference of 3.6 on BSI-18 at FU1. Outcome analysis was ITT. Results: Of 221 patients randomized (111 UC, 110 SC), 4 were ineligible and 1 lost to FU, leaving 110 UC, 106 SC. Groups appeared well balanced. Median age was 64, 52% male, 56% colon, 35% rectal cancer, 10% overlap. Stage I 7%, II 22%, III 71%. Intervention fidelity was acceptable. Baseline distress and QOL were similar to population norms. Between groups differences in distress at FU1 (primary outcome), distress at FU2 and SCN and QOL at FU1 and FU2 were small and non-significant. SC patients were more satisfied with survivorship care than UC patients (significant differences on 10 of 15 items). Conclusions: The addition of SC to UC did not have a beneficial effect on distress, SCN or QOL outcomes but SC patients were more satisfied with survivorship care. Clinical trial information: ACTRN12610000207011.