Optimizing Functional Recovery of Breast Cancer Survivors

  • STATUS
    Recruiting
  • End date
    Jan 26, 2023
  • participants needed
    300
  • sponsor
    Dartmouth-Hitchcock Medical Center
Updated on 26 March 2022
cancer
breast cancer

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.

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.

Details
Condition Breast Cancer Female
Treatment Attention Control Condition, The Behavioral Activation/ Problem Solving Intervention
Clinical Study IdentifierNCT03915548
SponsorDartmouth-Hitchcock Medical Center
Last Modified on26 March 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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