Optimizing Functional Recovery of Breast Cancer Survivors

Not Applicable

Completed

• Conditions: Breast Cancer Female

• Registration Number: NCT03915548
• Lead Sponsor: MGH Institute of Health Professions

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2019-04-03
• Study First Submitted QC: 2019-04-15
• Study First Posted: 2019-04-16
• Study Start: 2019-08-28
• Primary Completion: 2023-04-30
• Results First Submitted: 2024-03-01
• Study Completion: 2024-03-31
• Status Verified: 2024-05
• Results First Submitted QC: 2024-05-02
• Last Update Submitted: 2024-05-02
• Results First Posted: 2024-05-03
• Last Update Posted: 2024-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 303

Inclusion Criteria

1. Age of 18 years or older.
2. Experiencing reduced participation (i.e., a score greater than or equal to 10 on the Work and Social Adjustment Scale).
3. Females diagnosed with Stage 1-3 breast cancer and within one year of completion of locoregional treatment and/or chemotherapy with curative intent and absence of disease recurrence

Exclusion Criteria

1. Non-English speaking.
2. Non-correctable hearing loss.
3. Moderate-severe cognitive impairment indicated by a score < 3 on a 6-item cognitive screener.
4. History of severe mental illness (i.e., schizophrenia, bipolar disorder), current major depressive disorder, active suicidal ideation, or active substance misuse documented within the medical record.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Participation Ability in Social Roles and Activities	The overall treatment effect will be computed as between-group differences at weeks 8, 20, 44 (adjusted for baseline), estimated with a linear contrast.	The Patient Reported Outcomes Measurement Information System (PROMIS): Ability to Participate in Social Roles and Activities Short Form 8a measures participation with daily routines and activities. Raw scores (ranging 8-40) were converted to T-scores (mean = 50, SD = 10) with higher scores indicating better outcomes (i.e., greater ability to participate in daily routines and activities).
Productivity	The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline) estimated with a linear contrast.	Instrument name: Disability Days section of the Medical Expenditure Panel Survey (MEPS).; Range: 0- 30 days. Subscales: N/A. Interpretation: Higher values indicate lower productivity.
Work Productivity	The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline), estimated with a linear contrast.	The Work Limitations Questionnaire-Short Form (WLQ-SF) assesses productivity with an overall score indicating the percentage decrement in productivity in the previous two weeks. Scores range 0-100% with higher scores indicating greater decrement in productivity.
Participation Satisfaction in Social Roles and Activities: PROMIS	The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline) estimated with a linear contrast.	The Patient Reported Outcomes Measurement Information System (PROMIS): Satisfaction with Social Roles and Activities measures satisfaction with daily routines and activities. Raw scores (ranging 8-40) were converted to T-scores (mean = 50, SD = 10) with higher scores indicating better outcomes (i.e., greater satisfaction with daily routines and activities).

Secondary Outcome Measures

Name	Time	Method
Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G)	The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline), estimated with a linear contrast.	The Functional Assessment of Cancer Treatment (FACT) - General measures quality of life. The physical, social, and functional subscale scores can range 0-28 and the emotional subscale score can range 0-24; higher scores indicate better well-being. Overall score was calculated by summing the four subscales; overall scores can range from 0-108 with higher scores indicating better quality of life.

Trial Locations

Locations (2)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Dartmouth Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States