Optimizing Functional Recovery of Breast Cancer Survivors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Breast Cancer - Female
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: The investigators will recruit 300 women over the age of 18 reporting participation restrictions after completing curative treatment for Stage 1-3 breast cancer within the past year. Half of the participants will be randomized to the 4-month BA/PS intervention which consists of 6 weekly telephone calls followed by 3 monthly telephone calls. BA/PS is designed to teach problem-solving and action planning to promote functional recovery. The other half of participants will be assigned to an attention control condition providing education about survivorship topics. This control condition will allow us to account for the effect of time and history, and the non-specific effects of attentionMasking: Single (Outcomes Assessor)Masking Description: Assessments will be administered via telephone by a research assistant blind to group assignment.Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
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 p...
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.
Tracking Information
- NCT #
- NCT03915548
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Kathleen Lyons, ScD, OTR Dartmouth-Hitchcock Medical Center
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