Breast Cancer, Reasoning, and Activity Intervention
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Breast Cancer
- Breast Neoplasms
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Investigator, Outcomes Assessor)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 19 years and 125 years
- Gender
- Only males
Description
Aim 1: This study will compare changes in cognitive function and brain health in post-menopausal breast cancer survivors (BCS) randomized to either: 1) a community-based aerobic exercise program; or 2) a health education program (control group). Aim 2: Gather information on the intervention's potent...
Aim 1: This study will compare changes in cognitive function and brain health in post-menopausal breast cancer survivors (BCS) randomized to either: 1) a community-based aerobic exercise program; or 2) a health education program (control group). Aim 2: Gather information on the intervention's potential for scalability using the RE-AIM framework. Eligible BCS (N=160) will be randomized to one of the following 6-month programs: Aerobic Exercise Training (n=80; progressive moderate-intensity exercise delivered by community fitness center personal trainers) or Health Education (n=80; attention control receiving cancer support and education). To assess Aim 1, participants will complete measures at baseline (Month 0), post-intervention (Month 6), and follow-up (Month 12; i.e., 6 months after post-intervention). Aim 1 measures include: neurocognitive tasks, functional magnetic resonance imaging (fMRI; M0 and M6 only), graded exercise testing, physical activity monitoring (i.e., accelerometry), and questionnaires. To assess Aim 2, outcomes defined by the RE-AIM framework (a dissemination and implementation framework) will be measured, including: study reach(e.g., participation rate), intervention effectiveness (i.e., Aim 1), intervention adoption (e.g.,number of community sites invited that participate), implementation (e.g., fidelity of intervention delivery, participant satisfaction), and maintenance (e.g., Aim 1 maintenance of effects, participant retention). Findings of this study will lay the groundwork toward our long-term goal of disseminating an evidence-based program for managing cognitive impairment in individuals diagnosed with cancer.
Tracking Information
- NCT #
- NCT04816006
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Diane K Ehlers, PhD University of Nebraska