Supportive care intervention for patients with locally advanced rectal cancer
PATHWAYS: An Informational and Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer
NA · Massachusetts General Hospital · NCT05914766
This study is testing a new support program to help patients with locally advanced rectal cancer feel more confident and informed as they start their treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital (other) |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT05914766 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility and acceptability of a psychoeducational intervention designed to enhance self-efficacy in patients with locally advanced rectal cancer who are starting multimodality treatment. It consists of two phases, with the first phase testing the intervention on a small group of participants. The second phase will expand the participant pool to assess the refined intervention's effectiveness compared to standard care. Participants in the intervention group will receive coaching sessions focused on treatment-related information and support.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are newly diagnosed with locally advanced rectal cancer and are within 8 weeks of deciding to pursue multimodality therapy.
Not a fit: Patients with comorbid health conditions that interfere with study participation or those who have previously been treated for colorectal cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve patients' self-efficacy and quality of life during their treatment for rectal cancer.
How similar studies have performed: Other studies have shown promise in using psychoeducational interventions to support cancer patients, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Boston, Massachusetts and 1 other locations
- Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Kelsey Lau-Min, MD, MSCE — Massachusetts General Hospital
- Study coordinator: Kelsey Lau-Min, MD, MSCE
- Email: klau-min@mgh.harvard.edu
- Phone: 617-724-4000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Rectal Cancer, Self Efficacy, total neoadjuvant therapy, locally advanced rectal cancer, self efficacy, psychoeducational, multimodality treatment