Recruitment

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