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A Phase III, Randomized, Single Blind, Attention Controlled, Multi-center Study of the Effects of a Rehabilitation Intervention on Participation Restrictions of Female Breast Cancer Survivors
This study is a randomized controlled trial (RCT) to test the efficacy of a Behavioral Activation and Problem Solving (BA/PS) approach to improving activity participation over time as compared to an attention control condition within a sample of 300 breast cancer survivors reporting reduced activity participation after completing cancer treatment.
Assessments will be administered via telephone by a research assistant blind to group assignment. Participants will complete outcome assessments upon enrollment (T1) and at 8 weeks (T2), 20 weeks (T3) and 44 weeks (T4) later. The T2 assessment captures the short-term outcomes of the most intensive part of the intervention (i.e., after six weekly sessions). The T3 assessment will capture the short-term outcomes at the end of the full intervention. The T4 assessment explores the sustained effect of BA/PS (six months after BA/PS ends). The study aim is to test whether the BA/PS intervention affects the "slope" of functional recovery over time. With the longitudinal data, the investigators will also be able to explore the pace of improvement and whether the two groups differ at these clinically relevant time points.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
University of Alabama at Birmingham
Birmingham, Alabama, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Start Date
August 28, 2019
Primary Completion Date
April 30, 2023
Completion Date
March 31, 2024
Last Updated
May 3, 2024
303
ACTUAL participants
The Behavioral Activation/ Problem Solving Intervention
BEHAVIORAL
Attention Control Condition
BEHAVIORAL
Lead Sponsor
MGH Institute of Health Professions
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05116449