PATHWAYS: An Informational and Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Proportion of participants retained in the intervention (feasibility)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age≥18 years
- •Within 8 weeks after documented decision to pursue multi-modality therapy for newly diagnosed LARC (i.e., stage II or III disease)
- •Able to complete study procedures English or with the assistance of an interpreter
Exclusion Criteria
- •Comorbid health condition that would interfere with study participation, as identified by cancer care team
- •Has undergone treatment for a prior colorectal cancer
Arms & Interventions
Study Phase I: PATHWAYS Intervention
Participants assigned to the PATHWAYS Intervention will receive: 1) four coaching sessions, 2) a comprehensive patient education guidebook, and 3) a coaching session workbook.
Intervention: PATHWAYS (Behavioral)
Study Phase I: Enhanced Usual Care
Participants assigned to the enhanced usual care will receive: 1) an information resource guide for navigating information online.
Intervention: Enhanced usual care (Other)
Study Phase II: PATHWAYS Intervention
Participants assigned to the PATHWAYS Intervention will receive: 1) four coaching sessions and 2) a comprehensive patient education guidebook. The intervention has been modified and refined based on feedback from Study Phase I.
Intervention: PATHWAYS (Behavioral)
Study Phase II: Enhanced Usual Care
Participants assigned to the enhanced usual care will receive: 1) an information resource guide for navigating information online.
Intervention: Enhanced usual care (Other)
Outcomes
Primary Outcomes
Proportion of participants retained in the intervention (feasibility)
Time Frame: 4 weeks
The primary outcome will be feasibility, defined as ≥60% retention of participants over the four-week intervention.
Secondary Outcomes
- Proportion of patients enrolled on the study (feasibility)(12 weeks)
- Proportion of participants reporting acceptability of the intervention (acceptability)(12 weeks)
Investigators
Kelsey S. Lau-Min, MD
Principal Investigator
Massachusetts General Hospital