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Optimizing Functional Recovery of Breast Cancer Survivors

Breast Cancer Female Clinical Trial

Official title:
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

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03915548
Study type Interventional
Source MGH Institute of Health Professions
Contact
Status Completed
Phase N/A
Start date August 28, 2019
Completion date March 31, 2024
View Details
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