Actively Recruiting
PATHWAYS: An Informational and Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer
Led by Massachusetts General Hospital ยท Updated on 2025-05-18
80
Participants Needed
2
Research Sites
27 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the feasibility and acceptability of a psychoeducational intervention called PATHWAYS compared to enhanced usual care for patients with locally advanced rectal cancer starting neoadjuvant multimodality treatment. The study is designed as a randomized controlled trial to explore how well this intervention supports patient self-efficacy in managing treatment challenges and maintaining quality of life. The study has two phases: Phase I tested the initial PATHWAYS intervention with 20 participants, while Phase II is a pilot randomized trial with about 60 participants, assessing a refined PATHWAYS program. Participants in the PATHWAYS group receive four coaching sessions, a patient education guidebook, and a coaching workbook. Those in the enhanced usual care group receive an information resource guide tailored to patients with locally advanced rectal cancer. Participants will be assessed for how many remain in the intervention over four weeks and their acceptance of the intervention by 12 weeks. The trial includes enrollment tracking and measures acceptability of the intervention. Participants will engage in coaching sessions and complete study procedures in English or with interpreter help, with ongoing monitoring of retention and feedback throughout the study period.
CONDITIONS
Brief Title
An Informational and Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Within 8 weeks after deciding to pursue multi-modality therapy for newly diagnosed locally advanced rectal cancer (stage II or III)
- Able to complete study procedures in English or with an interpreter
You will not qualify if you...
- Having a health condition that would interfere with study participation as identified by the cancer care team
- Prior treatment for colorectal cancer
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or virtual)
Duration - Up to 12 weeks
Participants receive the PATHWAYS psychoeducational intervention or enhanced usual care involving coaching sessions and information resources to support management of multimodality treatment for locally advanced rectal cancer.
4 coaching sessions over 12 weeks
Duration - Up to 12 weeks
Participants complete assessments to evaluate feasibility, acceptability, and retention related to the intervention.
Assessments conducted during and after intervention period
Trial Site Locations
Total: 2 locations
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
K
Kelsey Lau-Min, MD, MSCE
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
4
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