An Informational and Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer
Purpose
The aim of this study is to evaluate the efficacy of a brief psychoeducational intervention to improve the self-efficacy of patients with locally advanced rectal cancer who are initiating multimodality treatment (e.g., total neoadjuvant therapy).
Conditions
- Rectal Cancer
- Self Efficacy
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Ageā„18 years 2. Within 4 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
- 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 Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- 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 Purpose
- Supportive Care
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
|
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. |
|
|
Experimental Study Phase II: 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. |
|
|
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. |
|
Recruiting Locations
Boston, Massachusetts 02114
More Details
- Status
- Recruiting
- Sponsor
- Massachusetts General Hospital
Detailed Description
This is a randomized control trial that will be split into two phases. Study Phase I will test 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 who are initiating multimodality treatment. It is expected that this phase will enroll 20 participants. Study Phase II will test the efficacy of the psychoeducational intervention after it has been refined using findings from Study Phase I. It is expected this phase will enroll 100 participants. In this study, participants will complete survey questions and will be randomly assigned to either receive the intervention (consisting of 4 coaching sessions with a study clinician, a comprehensive patient education guidebook, and a coaching session workbook) or enhanced usual care (consisting of an information resource guide for navigating information online). It is expected that about 120 people will take part in this research study.