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

Sponsor

University of Nebraska (Other)

Overall Status

Completed

CT.gov ID

NCT03980626

Collaborator

(none)

Enrollment

Location

Arms

21.5

Actual Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Breast Neoplasm Female	Behavioral: Walking	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Sep 30, 2019

Actual Primary Completion Date :

Jul 15, 2021

Actual Study Completion Date :

Jul 15, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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 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.
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.

Secondary Outcome Measures

Regional brain volume [Baseline, Week 12]
Magnetic Resonance Imaging (MRI) will be used to measure regional volume.
White matter structural integrity [Baseline, Week 12]
Diffusion tensor imaging (DTI) will be used to measure white matter structural integrity (fractional anisotropy, diffusivity).
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).
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.
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.
Objective Activity Behavior [Baseline, Week 12]
Objective activity behavior (average minutes per day) will be measured using actigraphy.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Nebraska Medical Center	Omaha	Nebraska	United States	68198-8440

Sponsors and Collaborators

University of Nebraska

Investigators

Principal Investigator: Diane K Ehlers, PhD, University of Nebraska

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Diane Ehlers, Assistant Professor, University of Nebraska

ClinicalTrials.gov Identifier:

NCT03980626

Other Study ID Numbers:

091-19

First Posted:

Jun 10, 2019

Last Update Posted:

Nov 3, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Diane Ehlers, Assistant Professor, University of Nebraska

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Nov 3, 2021