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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-21

Study Completion Date

2028-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Rectal Cancer Self Efficacy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized to either the intervention or enhanced usual care. Randomization will be stratified by treatment sequence (e.g., chemotherapy first vs. concurrent chemoradiation first).

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

PATHWAYS

Intervention Type BEHAVIORAL

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

Study Phase I: Enhanced Usual Care

Participants assigned to the enhanced usual care will receive: 1) an information resource guide for navigating information online.

Group Type ACTIVE_COMPARATOR

Enhanced usual care

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

PATHWAYS

Intervention Type BEHAVIORAL

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

Study Phase II: Enhanced Usual Care

Participants assigned to the enhanced usual care will receive: 1) an information resource guide for navigating information online.

Group Type ACTIVE_COMPARATOR

Enhanced usual care

Intervention Type OTHER

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

Interventions

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PATHWAYS

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

Intervention Type BEHAVIORAL

Enhanced usual care

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No