Breast Cancer Clinical Trial
Breast Cancer, Reasoning, and Activity Intervention
The objective of the proposed study is to test the effectiveness of aerobic exercise training, delivered in a community-based setting, for improving cognitive function in post-menopausal Breast Cancer Survivors (BCS).
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.
Able to provide medical record release to confirm eligibility
First, primary diagnosis of Stage I-IIIa breast cancer
Post-menopausal at the time of diagnosis
Post-surgery and completed primary treatment (i.e., surgery, chemotherapy, and/or radiation therapy) 3-24 months prior to enrollment
No evidence of possible cognitive impairment as assessed using the Telephone Interview of Cognitive status (TICS-M)
Self-report 20+ minutes of exercise on 2 or fewer days per week within the previous six months
Receive physician's clearance to participate in an exercise program
Ability to complete assessments by themselves or with assistance
Pre- or peri-menopausal at the time of diagnosis with breast cancer
Stage 0 breast cancer diagnosis OR metastatic disease
Currently receiving or <3 months since receiving chemotherapy or radiation therapy for cancer, or greater than 24 months post primary treatment
Planned surgery during the intervention period
Second cancer diagnosis (excluding non-invasive skin cancers; including breast cancer recurrence)
History of stroke, transient ischemic attack, other neurological disorders, or brain surgery involving tissue removal as confirmed via clinical determination
Clinically significant TICS-M score
Not able to provide physician re-clearance for exercise if required based upon clinically significant baseline exercise test
Contraindications to functional magnetic resonance imaging (fMRI) in accordance with the Mayo Clinic Department of Radiology safety protocols
Clinically significant MRI scan as determined by physician review in which the following is advised via radiologist overread: remarkable/abnormal limited diagnostic brain image with recommended medical follow-up
Enrolled in another physical activity program
Unable to walk without assistance or devices
Unwilling to complete study requirements
Unwilling to be randomized to the exercise group or health education group
Unable or unwilling to continuously wear and regularly sync/charge an activity tracker during the study period
Unable to travel regularly to the study locations for intervention sessions and data collection
Unwilling to return to enrolling institution for follow-up
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There is 1 Location for this study
Scottsdale Arizona, 85259, United States More Info
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