Pilot randomized trial of an informational and supportive care intervention for patients initiating multimodality therapy for locally advanced rectal cancer (LARC).

327 Background: Patients with LARC receive aggressive, multimodality treatment including chemotherapy, radiation, and surgery to maximize the potential for cure. However, patients often find this treatment paradigm overwhelming and difficult to navigate due to its lengthy, complex, and unpredictable nature. We developed “PATHWAYS,” an informational and supportive care intervention focused on 1) managing health, 2) building a support system, and 3) adjusting to life with cancer to enhance self-efficacy, social support, and coping as a means to improve mood and quality of life among patients initiating multimodality therapy for LARC. We sought to assess the feasibility and acceptability of PATHWAYS, and to refine the intervention based on patient feedback. Methods: We conducted a pilot randomized controlled trial (NCT05914766) among adult patients who were within four weeks of consenting for multimodality therapy for LARC. Participants were randomized 1:1 to receive PATHWAYS (an educational guide plus four weekly virtual 30-minute behavioral coaching sessions) or enhanced usual care (a curated list of online resources for patients with LARC). Participants completed questionnaires at baseline, 6 weeks, and 12 weeks, as well as in-depth interviews at 6 and 12 weeks to elicit feedback on study participation. The primary outcome was feasibility (60% of eligible patients enroll; 60% of PATHWAYS participants complete the intervention). The secondary outcome was acceptability (80% of PATHWAYS participants report satisfaction using the Client Satisfaction Questionnaire-8, CSQ-8). We assessed intervention fidelity by reviewing 20% of session recordings using a rating checklist. Results: We approached 35 eligible patients, of whom 20 (57%) enrolled (median age 55 years, 50% women, 75% non-Hispanic White, 60% married/partnered). Of the 10 patients randomized to PATHWAYS, 9 (90%) completed the intervention, all (100%) of whom reported satisfaction with the intervention as per the CSQ-8. In qualitative interviews, participants reported appreciating the supportive and tailored nature of PATHWAYS but had difficulty with navigating the educational guide’s multiple topic areas during their coaching sessions. They also reported finding the session length to be too short to adequately cover the intervention content. Review of session recordings demonstrated ≥80% protocol adherence in 7 (78%) of the 9 sessions that were evaluated. Conclusions: In this pilot RCT, we demonstrated high engagement with and acceptability of a novel informational and supportive care intervention among patients initiating multimodality therapy for LARC. Better integrating PATHWAY’s coaching strategies with the educational content and increasing session length may enhance intervention impact on patient self-efficacy for managing treatment for LARC. Clinical trial information: NCT05914766 .