Study on Physical Activity's Relationship With Cancer and Cognition
- Conditions
- Breast CancerBreast Neoplasm Female
- Interventions
- Behavioral: Walking
- Registration Number
- NCT03980626
- Lead Sponsor
- University of Nebraska
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 31
- Female
- Post-menopausal at time of diagnosis
- First, primary diagnosis of Stage I-IIIa breast cancer
- Completed treatment 3-24 months prior to study start
- Available to attend exercise sessions 3 times weekly for 12 weeks
- No scheduled travel >7 consecutive days during the intervention
- Agree to be randomized
- Willingness to wear, charge, and sync Fitbit
- English reading and speaking
- Physician's clearance to exercise
- Provide written informed consent
- Males
- Pre- or peri-menopausal at the time of diagnosis
- Stage 0 or metastatic disease
- Currently receiving chemotherapy or radiation therapy
- More than 24 months post-treatment
- Scheduled to receive breast surgery
- Second cancer diagnosis (excluding non-invasive skin cancers)
- Self-report an average of ≥60 minutes of moderate to vigorous physical activities (MVPA) per week for the previous 6 months
- Not cleared to exercise by a physician
- Not available to attend 3 times weekly exercise sessions for 12 weeks
- Out of town travel scheduled for >1 week during the intervention
- Unwilling to complete baseline assessments
- Unwilling to be randomized to the exercise or control group
- Unwilling to wear, charge, and sync the Fitbit during the study period
- Unable to read and speak in English
- Unwilling to provide written informed consent to participate
- Cognitive impairment prior to baseline assessment
- History of stroke, transient ischemic attack, other neurological disorders, or brain surgery involving tissue removal
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Walking Intervention Walking Walking participants will engage in the 3-times weekly walking program for 12 weeks.
- Primary Outcome Measures
Name Time Method Change in Executive Function Baseline, Week 12 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.
Change in Processing Speed Baseline, Week 12 A comprehensive neurocognitive battery will be administered to measure processing speed as defined by a latent factor of manifest indicators of processing speed tasks.
Change in Working Memory Baseline, Week 12 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.
- Secondary Outcome Measures
Name Time Method Resting state functional connectivity Baseline, Week 12 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).
White matter structural integrity Baseline, Week 12 Diffusion tensor imaging (DTI) will be used to measure white matter structural integrity (fractional anisotropy, diffusivity).
Cancer-related Fatigue Baseline, Week 12 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.
N2pc Amplitude Baseline, Week 12 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).
Cardiorespiratory Fitness Baseline, Week 12 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 Baseline, Week 12 Objective activity behavior (average minutes per day) will be measured using actigraphy.
Regional brain volume Baseline, Week 12 Magnetic Resonance Imaging (MRI) will be used to measure regional volume.
Trial Locations
- Locations (1)
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States