NCT05914766

An Informational and Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer

PATHWAYS: An Informational and Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the feasibility and acceptability of conducting a randomized trial of a brief psychoeducational intervention versus enhanced usual care for patients with locally advanced rectal cancer who are initiating neoadjuvant multimodality treatment.

Detailed description

This is a randomized controlled trial that is split into two phases. Study Phase I tested the feasibility and acceptability of a study evaluating a psychoeducational intervention relative to a control condition for improving self-efficacy in patients with locally advanced rectal cancer initiating multimodality treatment. This phase enrolled 20 participants. Study Part 2 was initially planned as an adequately powered RCT to evaluate intervention efficacy for enhancing patient self-efficacy for managing treatment-related challenges and maintaining quality of life. Due to the substantial refinements that were made to the PATHWAYS intervention and study procedures after Study Part 1, we have elected to change Study Part 2 to a second pilot randomized controlled trial to evaluate the feasibility and acceptability of the refined PATHWAYS study among a larger group of patients (n=60). Participants in the intervention arm will be invited to receive the PATHWAYS intervention, including 4 coaching sessions with a study clinician focused on information and support related to multimodality treatment for LARC. Participants in the control arm will receive an information resource guide that is tailored for patients with LARC. It is expected that about 80 people will take part in this research study.

Conditions

• Rectal Cancer
• Self Efficacy

Interventions

Type	Name	Description
BEHAVIORAL	PATHWAYS	The PATHWAYS intervention is a psychoeducational intervention comprised of four behavioral coaching sessions and a patient education guidebook.
OTHER	Enhanced usual care	The enhanced usual care condition consists of an information resource guide.

Timeline

• Start date: 2023-09-21
• Primary completion: 2028-05-21
• Completion: 2028-12-01
• First posted: 2023-06-22
• Last updated: 2025-05-18

Locations

2 sites across 1 country: United States