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

Not Applicable

Recruiting

• Conditions: Self Efficacy; Rectal Cancer
• Interventions: Other: Enhanced usual care; Behavioral: PATHWAYS

• Registration Number: NCT05914766
• Lead Sponsor: Massachusetts General Hospital

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 Timeline

• Study First Submitted: 2023-06-13
• Study First Submitted QC: 2023-06-13
• Study First Posted: 2023-06-22
• Study Start: 2023-09-21
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18
• Primary Completion: 2028-05-21
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Phase II: Enhanced Usual Care	Enhanced usual care	Participants assigned to the enhanced usual care will receive: 1) an information resource guide for navigating information online.
Study Phase I: Enhanced Usual Care	Enhanced usual care	Participants assigned to the enhanced usual care will receive: 1) an information resource guide for navigating information online.
Study Phase I: PATHWAYS Intervention	PATHWAYS	Participants assigned to the PATHWAYS Intervention will receive: 1) four coaching sessions, 2) a comprehensive patient education guidebook, and 3) a coaching session workbook.
Study Phase II: PATHWAYS Intervention	PATHWAYS	Participants assigned to the PATHWAYS Intervention will receive: 1) four coaching sessions, 2) a comprehensive patient education guidebook, and 3) a coaching session workbook.

Primary Outcome Measures

Name	Time	Method
Proportion of participants retained in the intervention (feasibility)	4 weeks	The primary outcome will be feasibility, defined as ≥60% retention of participants over the four-week intervention.

Secondary Outcome Measures

Name	Time	Method
Proportion of patients enrolled on the study (feasibility)	12 weeks	A secondary feasibility outcome will be defined as ≥60% enrollment among all eligible patients
Proportion of participants reporting acceptability of the intervention (acceptability)	12 weeks	A secondary outcome of acceptability will be defined as ≥80% of participants in the intervention arm reporting Client Satisfaction Questionnaire (CSQ-8) scores of ≥20 (scale from 8-32, higher scores indicate higher satisfaction).

Trial Locations

Locations (2)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States