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

Rectal Cancer Clinical Trial

Official title:
PATHWAYS: An Informational and Supportive Care Intervention to Enhance Self-Efficacy for Patients With Locally Advanced Rectal Cancer

Clinical Trial Summary

The aim of this study is to evaluate the efficacy of a brief psychoeducational intervention to improve the self-efficacy of patients with locally advanced rectal cancer who are initiating multimodality treatment (e.g., total neoadjuvant therapy).

Clinical Trial Description

This is a randomized control trial that will be split into two phases. Study Phase I will test 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 who are initiating multimodality treatment. It is expected that this phase will enroll 20 participants. Study Phase II will test the efficacy of the psychoeducational intervention after it has been refined using findings from Study Phase I. It is expected this phase will enroll 100 participants. In this study, participants will complete survey questions and will be randomly assigned to either receive the intervention (consisting of 4 coaching sessions with a study clinician, a comprehensive patient education guidebook, and a coaching session workbook) or enhanced usual care (consisting of an information resource guide for navigating information online). It is expected that about 120 people will take part in this research study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05914766
Study type Interventional
Source Massachusetts General Hospital
Contact Kelsey Lau-Min, MD, MSCE
Phone 617-724-4000
Email klau-min@mgh.harvard.edu
Status Recruiting
Phase N/A
Start date September 21, 2023
Completion date September 2026
View Details
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