Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05914766

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms Self Efficacy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PATHWAYS

Behavioral

The PATHWAYS intervention is a psychoeducational intervention comprised of four behavioral coaching sessions and a patient education guidebook.

Enhanced usual care

Other

The enhanced usual care condition consists of an information resource guide.

Primary outcomes

  1. 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

  1. Proportion of patients enrolled on the study (feasibility)

    Time frame: 12 weeks

    A secondary feasibility outcome will be defined as ≥60% enrollment among all eligible patients

  2. Proportion of participants reporting acceptability of the intervention (acceptability)

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Kelsey Lau-Min, MD, MSCE

CONTACT

[email protected]

617-724-4000

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Acronym: PATHWAYS

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jun 22, 2023
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.