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Trial Title:
An Informational and Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer
NCT ID:
NCT05914766
Condition:
Rectal Cancer
Self Efficacy
Conditions: Official terms:
Rectal Neoplasms
Conditions: Keywords:
total neoadjuvant therapy
locally advanced rectal cancer
self efficacy
psychoeducational
multimodality treatment
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
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)
Intervention:
Intervention type:
Behavioral
Intervention name:
PATHWAYS
Description:
The PATHWAYS intervention is a psychoeducational intervention comprised of three
components.
Arm group label:
Study Phase I: PATHWAYS Intervention
Arm group label:
Study Phase II: PATHWAYS Intervention
Intervention type:
Other
Intervention name:
Enhanced usual care
Description:
The enhanced usual care condition consists of an information resource guide.
Arm group label:
Study Phase I: Enhanced Usual Care
Arm group label:
Study Phase II: Enhanced Usual Care
Summary:
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).
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. 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:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kelsey Lau-Min, MD, MSCE
Phone:
617-724-4000
Email:
klau-min@mgh.harvard.edu
Investigator:
Last name:
Kelsey Lau-Min, MD, MSCE
Email:
Principal Investigator
Start date:
September 21, 2023
Completion date:
September 2026
Lead sponsor:
Agency:
Massachusetts General Hospital
Agency class:
Other
Source:
Massachusetts General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05914766
