CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 303 enrolled
Drug / intervention
The Behavioral Activation/ Problem Solving Intervention +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03915548
NCT03915548N/ACompleted

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

MGH Institute of Health Professions·interventional·Posted Apr 16, 2019·Updated May 3, 2024

In Brief

A clinical study evaluating The Behavioral Activation/ Problem Solving Intervention and Attention Control Condition for Breast Cancer Female. Completed, enrolled 303 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedApr 16, 2019
Enrollment StartAug 28, 2019
Primary CompletionApr 30, 2023
Study CompletionMar 31, 2024
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 7.2 years ago

Interventions

The Behavioral Activation/ Problem Solving Interventionbehavioral

The interventionist presents the rationale for BA/PS, promotes a positive problem orientation, and educates about the framework for problem-solving and action planning. The interventionist then administers the Canadian Occupational Performance Measure to elicit participant priorities, motivation, and long-term goals. The interventionist then guides the participant in using the BA/PS framework to set a goal, brainstorm solutions to challenges, and create a detailed action plan for the coming week.

Attention Control Conditionbehavioral

The interventionist provides education regarding nine cancer survivorship topics (i.e., healthy diets, physical activity, lymphedema management, smoking cessation, stress management, communication with providers, body image and sexuality, communication with social supports, work accommodations) during the control telephone contacts.