Pilot Randomized Trial of a Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer

Multimodality therapy for locally advanced rectal cancer (LARC) is lengthy, complex, and overwhelming for patients to navigate. We developed "PATHWAYS," an informational and supportive care intervention tailored to 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.

We conducted a pilot randomized controlled trial among patients initiating multimodality therapy for LARC. We randomized participants 1:1 to receive PATHWAYS (an educational guide plus four behavioral coaching sessions) or enhanced usual care (a curated list of online resources). Participants completed questionnaires at baseline, six, and 12 weeks, and in-depth interviews at six 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).

Among 34 eligible patients approached, 20 (59%) enrolled (mean age 56.8 years, 50% women, 75% non-Hispanic White). Of the 10 patients randomized to PATHWAYS, nine (90%) completed the intervention, all (100%) of whom found the intervention acceptable. In qualitative interviews, participants reported using the PATHWAYS guide to enhance knowledge and the coaching sessions to make learning more manageable and tailored to their needs.

In this pilot randomized controlled trial, we demonstrated high engagement and acceptability of a novel supportive care intervention for patients with LARC. Study results will guide refinements to the PATHWAYS intervention and future study procedures.