Study on Physical Activity's Relationship With Cancer and Cognition (SPARCC)

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Breast Neoplasm Female
• Intervention / Treatment: Behavioral: Walking

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68198-8440
      • University of Nebraska Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Walking Intervention; Walking participants will engage in the 3-times weekly walking program for 12 weeks.	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.; Other Names: Aerobic Exercise Training
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Executive Function	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.	Baseline, Week 12
Change in Working Memory	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.	Baseline, Week 12
Change in Processing Speed	A comprehensive neurocognitive battery will be administered to measure processing speed as defined by a latent factor of manifest indicators of processing speed tasks.	Baseline, Week 12

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Nebraska
• Investigators: Principal Investigator: Diane K Ehlers, PhD, University of Nebraska

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2019
• Primary Completion (Actual): July 15, 2021
• Study Completion (Actual): July 15, 2021

Study Registration Dates

• First Submitted: May 28, 2019
• First Submitted That Met QC Criteria: June 7, 2019
• First Posted (Actual): June 10, 2019

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: physical activity; breast cancer; exercise; cognition; brain health
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 0091-19-FB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data will be available upon request as required by journal publishers during dissemination phase of the study.
• IPD Sharing Time Frame: When summary data are published.
• IPD Sharing Access Criteria: IPD will be provided as required by journals in which summary data are published.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No