PATHWAYS: An Informational and Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer
Massachusetts General Hospital
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.
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 refinem…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age≥18 years 2. Within 8 weeks after documented decision to pursue multi-modality therapy for newly diagnosed LARC (i.e., stage II or III disease) 3. Able to complete study procedures English or with the assistance of an interpreter Exclusion Criteria: 1. Comorbid health condition that would interfere with study participation, as identified by cancer care team 2. Has undergone treatment for a prior colorectal cancer
Interventions
- BehavioralPATHWAYS
The PATHWAYS intervention is a psychoeducational intervention comprised of four behavioral coaching sessions and a patient education guidebook.
- OtherEnhanced usual care
The enhanced usual care condition consists of an information resource guide.
Locations (2)
- Massachusetts General HospitalBoston, Massachusetts
- Dana-Farber Cancer InstituteBoston, Massachusetts