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

Primary Purpose

Breast Cancer, Breast Neoplasm Female

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Walking

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring physical activity, exercise, cognition, brain health, breast cancer

Eligibility Criteria

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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

Sites / Locations

University of Nebraska Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Walking Intervention

Usual Care

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

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.

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.

Secondary Outcome Measures

Regional brain volume

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

White matter structural integrity

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

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).

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).

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.

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.

Objective Activity Behavior

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

Full Information

NCT ID

NCT03980626

First Posted

May 28, 2019

Last Updated

September 27, 2023

Sponsor

University of Nebraska

1. Study Identification

Unique Protocol Identification Number

NCT03980626

Brief Title

Study on Physical Activity's Relationship With Cancer and Cognition

Acronym

SPARCC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

September 30, 2019 (Actual)

Primary Completion Date

July 15, 2021 (Actual)

Study Completion Date

July 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Nebraska

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Breast Neoplasm Female

Keywords

physical activity, exercise, cognition, brain health, breast cancer

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Walking Intervention

Arm Type

Experimental

Arm Description

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

Arm Title

Usual Care

Arm Type

No Intervention

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Walking

Other Intervention Name(s)

Aerobic Exercise Training

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Executive Function

Description

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.

Time Frame

Baseline, Week 12

Title

Change in Working Memory

Description

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.

Time Frame

Baseline, Week 12

Title

Change in Processing Speed

Description

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

Time Frame

Baseline, Week 12

Secondary Outcome Measure Information:

Title

Regional brain volume

Description

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

Time Frame

Baseline, Week 12

Title

White matter structural integrity

Description

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

Time Frame

Baseline, Week 12

Title

Resting state functional connectivity

Description

Time Frame

Baseline, Week 12

Title

N2pc Amplitude

Description

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).

Time Frame

Baseline, Week 12

Title

Cardiorespiratory Fitness

Description

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.

Time Frame

Baseline, Week 12

Title

Cancer-related Fatigue

Description

Time Frame

Baseline, Week 12

Title

Objective Activity Behavior

Description

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

Time Frame

Baseline, Week 12

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Diane K Ehlers, PhD

Organizational Affiliation

University of Nebraska

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Nebraska Medical Center

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68198-8440

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

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Study on Physical Activity's Relationship With Cancer and Cognition

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