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

PATHWAYS: 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.

Study Overview

• Status: Recruiting
• Conditions: Rectal Cancer; Self Efficacy
• Intervention / Treatment: Other: Enhanced usual care; Behavioral: PATHWAYS

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
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kelsey Lau-Min, MD, MSCE; Phone Number: 617-724-4000; Email: klau-min@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Kelsey Lau-Min, MD, MSCE; Phone Number: 617-724-4000; Email: klau-min@mgh.harvard.edu
      • Principal Investigator: Kelsey Lau-Min, MD, MSCE
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana-Farber Cancer Institute
      • Contact: Christo Manz, MD, MSHP; Phone Number: 617-632-3315; Email: christopher_manz@dfci.harvard.edu
      • Principal Investigator: Christopher Manz, MD, MSHP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: PATHWAYS; The PATHWAYS intervention is a psychoeducational intervention comprised of four behavioral coaching sessions and a patient education guidebook.
Active Comparator: Study Phase I: Enhanced Usual Care; Participants assigned to the enhanced usual care will receive: 1) an information resource guide for navigating information online.	Other: Enhanced usual care; The enhanced usual care condition consists of an information resource guide.
Active Comparator: Study Phase II: Enhanced Usual Care; Participants assigned to the enhanced usual care will receive: 1) an information resource guide for navigating information online.	Other: Enhanced usual care; The enhanced usual care condition consists of an information resource guide.
Experimental: 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.	Behavioral: PATHWAYS; The PATHWAYS intervention is a psychoeducational intervention comprised of four behavioral coaching sessions and a patient education guidebook.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients enrolled on the study (feasibility)	A secondary feasibility outcome will be defined as ≥60% enrollment among all eligible patients	12 weeks
Proportion of participants reporting acceptability of the intervention (acceptability)	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).	12 weeks

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Kelsey Lau-Min, MD, MSCE, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2023
• Primary Completion (Estimated): May 21, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: June 13, 2023
• First Submitted That Met QC Criteria: June 13, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): May 18, 2025
• Last Update Submitted That Met QC Criteria: May 14, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: self efficacy; locally advanced rectal cancer; multimodality treatment; total neoadjuvant therapy; psychoeducational
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Rectal Neoplasms
• Other Study ID Numbers: 23-115

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Partners Innovations team at link below
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No