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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

PATHWAYS Trial 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.Check my eligibility
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.See study design
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.

PATHWAYS Trial 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

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

PATHWAYS 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
2,935 Previous Clinical Trials
13,198,521 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the ultimate goal of this investigation?

"During the first four weeks of this clinical trial (Phase I), its primary measure will be Self-Efficacy in Cancer Patients (CASE-Cancer). Secondary measurements include Self-Efficacy as determined by Patient Reported Outcomes Measurement Information System (PROMIS); Coping Capacity evaluated utilizing Brief Cope; and Resilience quantified via a Brief Resilience Scale. Respective scores range from 8 to 40, 28 to 112, and 6 to 30 respectively with higher numbers indicating an increased ability in each category."

Answered by AI

Is participation in this clinical trial available to those seeking its potential benefits?

"The data hosted on clinicaltrials.gov attests that this trial is no longer enrolling patients, as the last time it was updated was June 22nd 2023. Luckily for those in search of a suitable medical study, there are presently 388 other registered trials actively recruiting participants."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
An Informational and Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer
Kelsey S. Lau-Min, MD 2023. "An Informational and Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05914766.
~80 spots leftby Sep 2026
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