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Supportive Care for Rectal Cancer (PATHWAYS Trial)

N/A
Recruiting
Led By Kelsey Lau-Min, MD, MSCE
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks (study phase i only)
Awards & highlights

Summary

This trial studies how to help people with rectal cancer feel more confident before starting treatments.

Who is the study for?
This trial is for adults over 18 with newly diagnosed stage II or III locally advanced rectal cancer, who are starting combined treatments. Participants must be able to complete study tasks in English or with an interpreter's help.
What is being tested?
The trial tests a brief psychoeducational program called PATHWAYS against enhanced usual care to see if it can boost patients' confidence in managing their rectal cancer treatment and its effects.
What are the potential side effects?
Since the intervention is informational and supportive rather than medical, there may not be direct side effects like those from drugs; however, emotional distress or anxiety could potentially arise from discussing cancer-related topics.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks (study phase i only)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks (study phase i only) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of participants retained in the intervention (feasibility)
Self-Efficacy (CASE-Cancer)
Secondary study objectives
Coping
Decisional Regret
Proportion of participants reporting acceptability of the intervention (acceptability)
+6 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Study Phase II: PATHWAYS InterventionExperimental Treatment1 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 II: Study Phase I: PATHWAYS InterventionExperimental Treatment1 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 III: Study Phase I: Enhanced Usual CareActive Control1 Intervention
Participants assigned to the enhanced usual care will receive: 1) an information resource guide for navigating information online.
Group IV: Study Phase II: Enhanced Usual CareActive Control1 Intervention
Participants assigned to the enhanced usual care will receive: 1) an information resource guide for navigating information online.

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,993 Previous Clinical Trials
13,230,601 Total Patients Enrolled
Kelsey Lau-Min, MD, MSCEPrincipal InvestigatorMassachusetts General Hospital

Media Library

Study Phase I: PATHWAYS Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05914766 — N/A
Colorectal Cancer Research Study Groups: Study Phase I: PATHWAYS Intervention, Study Phase I: Enhanced Usual Care, Study Phase II: PATHWAYS Intervention, Study Phase II: Enhanced Usual Care
Colorectal Cancer Clinical Trial 2023: Study Phase I: PATHWAYS Intervention Highlights & Side Effects. Trial Name: NCT05914766 — N/A
Study Phase I: PATHWAYS Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05914766 — N/A
~79 spots leftby Sep 2026
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