Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Behaviors and Mental Disorders

Breast Neoplasms

Cognitive Dysfunction

Breast Diseases

Skin Diseases

Cognition Disorders

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Patients attend 3 weekly exercise sessions in weeks 1-2, 2 sessions each week in weeks 3-4, 1 session each week in weeks 5-8, biweekly sessions across weeks 9-16, and monthly sessions in weeks 17-24 for a total of 20 supervised sessions. Patients undergo MRI and wear an accelerometer throughout the study.

Patients participate in up to 9 monthly classes/webinars. Patients also receive informational pdfs, videos, and/or podcasts, and a one-year subscription to the Mayo Clinic Health Letter. Patients undergo a gait assessment and MRI, as well as wear an accelerometer throughout the study.

Breast cancer survivors in the intervention group will participate in a 24-week moderate intensity exercise program led by community-based fitness center personal trainers. Individually-tailored exercise prescriptions will be developed based upon each participant's baseline maximal graded exercise test (heart rate corresponding with %VO2 peak) and symptom limitation. Sessions will be progressive in nature such that the volume of exercise increases across weeks. Treadmill walking is the primary mode of exercise. However, participants will be permitted to use other cardiovascular equipment (e.g., elliptical machines, stationary bicycles) as prescribed by their exercise trainer. The trainer will supervise three weekly exercise sessions in Weeks 1-2, two in Weeks 3-4, one in Weeks 5-8, biweekly across weeks 9-16, and monthly in Weeks 17-24 (N=20 supervised sessions).

Aerobic Exercise Training

Breast cancer survivors in the Health Education group will participate in education sessions with a health educator and receive monthly newsletters/webinars (N=20 total contacts) across 24 weeks. The program will include cancer support and discussion of cancer-related wellness topics (e.g., stress management, coping). Control group participants will be offered a 6-month fitness center membership upon study completion.

Health Education (Active comparator)

Magnetic Resonance Imaging

Medical Device Usage and Evaluation

Gait Assessment

Gabriella Hickman, MS

Clinical Trials Referral Office

Diane K. Ehlers, Ph.D.

This phase II trial tests whether an exercise intervention works to improve cognitive function in breast cancer survivors. Many breast cancer survivors report cancer-related cognitive impairment, which this has recently become a priority in clinical research due to its dramatic impact on daily functioning, quality of life, and long-term health. Aerobic exercise has the potential to improve cognitive function and brain health in older adults and is recommended as a safe, tolerable, and accessible complementary therapy for breast cancer survivors. This study aims to understand the effects of physical activity compared with health education on memory, attention, and brain health in women with breast cancer. Study findings may help researchers design more programs that can improve memory, attention, and brain health in other women with breast cancer.

PRIMARY OBJECTIVES:

I. Examine the effectiveness of a 6-month, community-based aerobic exercise intervention on multiple indicators of cognitive function in post-menopausal breast cancer survivors.

II. Gather information on the intervention's potential for scalability using the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework.

EXPLORATORY OBJECTIVE:

I. Explore potential moderators and mediators of the effects of aerobic exercise training on cognitive function.

II. Investigate the feasibility of urinary metabolites as biomarkers of overall diet patterns.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients attend 3 weekly exercise sessions in weeks 1-2, 2 sessions each week in weeks 3-4, 1 session each week in weeks 5-8, biweekly sessions across weeks 9-16, and monthly sessions in weeks 17-24 for a total of 20 supervised sessions. Patients undergo a gait assessment and magnetic resonance imaging (MRI), as well as wear an accelerometer throughout the study.

ARM II: Patients participate in up to 9 monthly classes/webinars. Patients also receive informational portable document format (pdfs), videos, and/or podcasts, and a one-year subscription to the Mayo Clinic Health Letter. Patients undergo a gait assessment and MRI, as well as wear an accelerometer throughout the study.

After completion of study intervention, patients are followed up with at 12 months.

Breast Cancer, Reasoning, and Activity Intervention

Enhancing Cognitive Function in Breast Cancer Survivors Through Community-based Exercise Training

Although the final dataset will not include identifying information, there is still a possibility of deductive disclosure of identity. Therefore, data will not be shared via an NIH or approved public repository; however, we will share de-identified data as required for publication in scientific journals and with outside collaborators and scientists upon request.

Change in interference score on Stroop task, with negative values indicating lower inhibitory control.

Change in reaction time on Task-switch task, with higher values indicating lower cognitive flexibility

Change in completion time on Trails B task, with higher values indicating lower executive function.

Change in reaction time on spatial working memory task, with faster reaction times indicating better spatial working memory

Change in accuracy on N-Back task, with higher accuracy indicating better short-term memory

Change in number recalled on Auditory Verbal Learning task, with greater number of items recalled indicating better verbal memory

change in response time, with shorter response time associated with faster relational memory processes

Change in accuracy on Flanker task, with greater accuracy indicating better working memory

change in mean cortical thickness of brain regions of interest as measured by an anatomic MRI brain scan

change in fractional anisotropy as measured by diffusion MRI.

change in within-network pairwise correlation estimates as measured using a multiband echo planar imaging (mb-EPI) functional MRI sequence

The perceived cognitive impairments subscale of the Functional Assessment in Cancer Therapy - Cognition (FACT-Cog) will be used to measure self-reported cognition. Scores range from 0-72, with higher scores indicating better cognitive function.

Participation rate among eligible individuals contacted about the study.

sociodemographics questionnaire to describe demographics characteristics and experience among personal trainers

Change in Peak VO2 as measured by a modified Balke treadmill graded exercise test protocol.

The Functional Assessment in Chronic Illness Therapy (FACIT) - Fatigue Scale will be used to measure cancer-related fatigue. Scores range from 0-52, with higher scores indicating less cancer-related fatigue.

percent of session checklist items completed as intended

The number of participants who withdraw during the follow-up period.

National Cancer Institute (NCI)

Mayo Clinic

Principal Investigator

Walking participants will engage in the 3-times weekly walking program for 12 weeks.

Usual care participants will be offered two personalized exercise sessions with a trained exercise specialist after all post-intervention data have been collected.

The exercise intervention is designed to improve cardiorespiratory fitness, a known correlate of cognition and brain health, and follows the American College of Sports Medicine exercise guidelines for cancer survivors. Participants will engage in small group, moderate-to-vigorous intensity walking sessions three times weekly. Sessions will begin with a warm-up and end with a cool down and be progressive in nature. Volume of exercise will increase across weeks such that participants will progress from 15-20 minutes of walking to 40-45 minutes by week 8, and from 40-55% of their estimated heart rate reserve (HRR) to 65% of their HRR by week 9. All sessions will be led by trained exercise specialists to ensure close monitoring of participant safety. Participants will wear heart rate monitors and be asked to rate their perceived exertion to ensure they are exercising within the prescribed range. Modifications to each participant's exercise prescription will be made as needed.

Walking

Diane K Ehlers, PhD

This pilot study tests the effects of aerobic exercise training on cognitive function in breast cancer survivors (BCS). Participants will be randomized to a 12-week walking intervention or usual care. Walking participants will attend small group sessions led by an exercise specialist 3 times weekly. Usual care participants will complete baseline and post-testing and be offered two sessions with an exercise specialist. All participants will complete a fitness test, electrophysiology, and patient-reported outcomes at baseline and post-intervention. A subset of participants will also be invited to undergo magnetic resonance imaging (MRI). The investigators will generate preliminary data on clinical and biological correlates of exercise and cognition, including treatment protocol, cardiorespiratory fitness, brain structure and function, and cancer-related fatigue.

Aim 1: This pilot study tests the effects of aerobic exercise training on cognitive function in breast cancer survivors (BCS). To test aim 1, the investigators will randomize up to forty post-menopausal BCS (3-24 months post-treatment) to a 12-week walking intervention (n=20) or usual care (n=20). Walking participants will attend small group (n=3-5 BCS) sessions led by an exercise specialist 3 times weekly. Usual care participants will complete baseline and post-testing and be offered two sessions with an exercise specialist after all data have been collected. Aim 1 measures include accelerometry, neurocognitive testing, and patient-reported outcomes at baseline and post-intervention.

Aim 2: The investigators will generate preliminary data on clinical and biological correlates of exercise and cognition, including treatment protocol, cardiorespiratory fitness, brain structure and function, and cancer-related fatigue. To test aim 2, all participants will complete a fitness test, electrophysiology, and patient-reported outcomes at baseline and post-intervention. A subset of participants will also be invited to undergo magnetic resonance imaging (MRI).

Data will be analyzed using descriptive statistics and analysis of covariance, and effect sizes expressed as standard mean difference will be calculated.

Study on Physical Activity's Relationship With Cancer and Cognition

Study on Physical Activity's Relationship With Cancer and Cognition: A Pilot Randomized Trial

De-identified data will be available upon request as required by journal publishers during dissemination phase of the study.

A comprehensive neurocognitive battery will be administered to measure executive function as defined by a latent factor of manifest indicators of performance on executive function tasks.

A comprehensive neurocognitive battery will be administered to measure working memory as defined by a latent factor of manifest indicators of performance on working memory tasks.

A comprehensive neurocognitive battery will be administered to measure processing speed as defined by a latent factor of manifest indicators of processing speed tasks.

Magnetic Resonance Imaging (MRI) will be used to measure regional volume.

Diffusion tensor imaging (DTI) will be used to measure white matter structural integrity (fractional anisotropy, diffusivity).

Resting state function MRI will be used to measure resting state functional connectivity (patterns of blood oxygen level dependent (BOLD) activity within seed regions of interest compared to whole brain activity).

N2pc amplitude is a neural measure of spacial attention during the Visual Search Task (measured in microvolts) to be measured with electroencephalography (Visual Search Task, Change Detections Task).

Fitness will be measured with a submaximal exercise test. The Naughton Protocol for submaximal graded exercise tests will be used to examine change in cardiovascular fitness.

Objective activity behavior (average minutes per day) will be measured using actigraphy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Breast Cancer, Reasoning, and Activity Intervention	NCT04816006	Breast Cancer Breast Neoplasm... Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Cancer-related ...	Aerobic Exercis... Health Educatio... Magnetic Resona... Medical Device ... Gait Assessment	18 Years -	Mayo Clinic
Breast Cancer, Reasoning, and Activity Intervention	NCT04816006	Breast Cancer Breast Neoplasm... Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Cancer-related ...	Aerobic Exercis... Health Educatio... Magnetic Resona... Medical Device ... Gait Assessment	18 Years -	Mayo Clinic
Study on Physical Activity's Relationship With Cancer and Cognition	NCT03980626	Breast Cancer Breast Neoplasm...	Walking	-	University of Nebraska

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