Breast Cancer Clinical Trial

Optimizing Functional Recovery of Breast Cancer Survivors

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.

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Full 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.

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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.

Study is for people with:

Breast Cancer

Estimated Enrollment:

300

Study ID:

NCT03915548

Recruitment Status:

Active, not recruiting

Sponsor:

MGH Institute of Health Professions

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There is 1 Location for this study

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Dartmouth Hitchcock Medical Center
Lebanon New Hampshire, 03756, United States

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Study is for people with:

Breast Cancer

Estimated Enrollment:

300

Study ID:

NCT03915548

Recruitment Status:

Active, not recruiting

Sponsor:


MGH Institute of Health Professions

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