N/A
N=284
Optimizing Functional Recovery of Breast Cancer Survivors
Breast Cancer Female
Bottom Line
View on ClinicalTrials.gov: NCT03915548 ↗Enrolled (actual)
284
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Participation Satisfaction in Social Roles and Activities: PROMIS — 45.75; 46; 48.09; 47.61 T-score — p=.54
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- The Behavioral Activation/ Problem Solving Intervention (Behavioral); Attention Control Condition (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- MGH Institute of Health Professions
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participation Satisfaction in Social Roles and Activities: PROMIS |
45.75; 46; 48.09; 47.61; 50.47; 49.81 | .54 |
| PRIMARY Participation Ability in Social Roles and Activities |
43.55; 43.48; 45.55; 44.95; 47.27; 46.44 | .09 |
| PRIMARY Productivity |
1.32; 1.15; 1.03; .91; 1.22; .87 | .55 |
| PRIMARY Work Productivity |
34.7; 34.15; 27.87; 25.35; 25.13; 23.57 | .99 |
| SECONDARY Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G) |
69.66; 69.45; 73.44; 73.36; 76.25; 76.49 | 0.99 |
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.
Eligibility Criteria
Inclusion Criteria
- Age of 18 years or older.
- Experiencing reduced participation (i.e., a score greater than or equal to 10 on the Work and Social Adjustment Scale).
- 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
- Non-English speaking.
- Non-correctable hearing loss.
- Moderate-severe cognitive impairment indicated by a score < 3 on a 6-item cognitive screener.
- 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.
Data sourced from ClinicalTrials.gov (NCT03915548). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.