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NCT05914766 | RECRUITING | Rectal Cancer

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

Massachusetts General Hospital

Information provided by (Responsible Party):

Kelsey S. Lau-Min, MD

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.

Condition or disease

Rectal Cancer

Self Efficacy

Intervention/treatment

PATHWAYS

Enhanced usual care

Phase

NA

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 Type : INTERVENTIONAL
Estimated Enrollment : 80 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : PATHWAYS: An Informational and Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer
Actual Study Start Date : 2023-09-21
Estimated Primary Completion Date : 2028-05-21
Estimated Study Completion Date : 2028-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
An Informational and Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer

Location Details

NCT05914766

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

RECRUITING

United States, Massachusetts

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215