Study on Physical Activity’s Relationship With Cancer and Cognition

Overview

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.

Full Title of Study: “Study on Physical Activity’s Relationship With Cancer and Cognition: A Pilot Randomized Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 30, 2020

Interventions

  • Behavioral: Walking
    • 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.

Arms, Groups and Cohorts

  • Experimental: Walking Intervention
    • Walking participants will engage in the 3-times weekly walking program for 12 weeks.
  • No Intervention: Usual Care
    • Usual care participants will be offered two personalized exercise sessions with a trained exercise specialist after all post-intervention data have been collected.

Clinical Trial Outcome Measures

Primary Measures

  • Change in Executive Function
    • Time Frame: 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 Working Memory
    • Time Frame: 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.
  • Change in Processing Speed
    • Time Frame: 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.

Secondary Measures

  • Regional brain volume
    • Time Frame: Baseline, Week 12
    • Magnetic Resonance Imaging (MRI) will be used to measure regional volume.
  • White matter structural integrity
    • Time Frame: Baseline, Week 12
    • Diffusion tensor imaging (DTI) will be used to measure white matter structural integrity (fractional anisotropy, diffusivity).
  • Resting state functional connectivity
    • Time Frame: 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).
  • N2pc Amplitude
    • Time Frame: 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
    • Time Frame: 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.
  • Cancer-related Fatigue
    • Time Frame: 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.
  • Objective Activity Behavior
    • Time Frame: Baseline, Week 12
    • Objective activity behavior (average minutes per day) will be measured using actigraphy.

Participating in This Clinical Trial

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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 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

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Nebraska
  • Provider of Information About this Clinical Study
    • Principal Investigator: Diane Ehlers, Assistant Professor – University of Nebraska
  • Overall Official(s)
    • Diane K Ehlers, PhD, Principal Investigator, University of Nebraska
  • Overall Contact(s)
    • Lindsey L Hanson, MS, 402-559-6870, lindsey.hanson@unmc.edu

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