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

Massachusetts General Hospital80 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Rectal Cancer Self Efficacy

Interventions

PATHWAYSBEHAVIORAL

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

Enhanced usual careOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Massachusetts General Hospital

Boston, Massachusetts, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 4 weeks

Secondary Outcomes

Proportion of patients enrolled on the study (feasibility)

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

Time frame: 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).

Time frame: 12 weeks

Central Contacts

Kelsey Lau-Min, MD, MSCE

CONTACT

617-724-4000 klau-min@mgh.harvard.edu

Data from ClinicalTrials.gov

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