Breast CancerSPARCCNCT03980626
Study on Physical Activity's Relationship With Cancer and Cognition
A study testing Walking in people with Breast Cancer and Breast Neoplasm Female, run by University of Nebraska at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer, Breast Neoplasm Female
- What is being tested?
- Walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2019to 15 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- Agree to be randomized
- Willingness to wear, charge, and sync Fitbit
- English reading and speaking
- Physician's clearance to exercise
- Provide written informed consent
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198-8440
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer, Breast Neoplasm Female
- Being tested
- Walking
- Keywords
- physical activity, exercise, cognition, brain health, breast cancer
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WalkingBehavioural
Also called Aerobic Exercise Training
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.
| Study group | Role | What they receive |
|---|---|---|
| Walking Intervention | Experimental | Walking participants will engage in the 3-times weekly walking program for 12 weeks. Receives: Behavioral: Walking |
| Usual Care | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 12
Secondary outcomes (7)
Regional brain volume
Magnetic Resonance Imaging (MRI) will be used to measure regional volume.
Measured: Baseline, Week 12
White matter structural integrity
Diffusion tensor imaging (DTI) will be used to measure white matter structural integrity (fractional anisotropy, diffusivity).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline, Week 12
Objective Activity Behavior
Objective activity behavior (average minutes per day) will be measured using actigraphy.
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start30 Sep 2019
- Primary completion15 Jul 2021
- Study completion15 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diane K Ehlers, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03980626
- Sponsor's protocol ID
- 0091-19-FB
- Acronym
- SPARCC
- Status last verified
- Aug 2024
- First submitted
- 28 May 2019
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be available upon request as required by journal publishers during dissemination phase of the study.
Publications
Page LL, Fanning J, Phipps C, Berger A, Reed E, Ehlers D. Heart Rate Monitoring Among Breast Cancer Survivors: Quantitative Study of Device Agreement in a Community-Based Exercise Program. JMIR Cancer. 2024 Jun 20;10:e51210. doi: 10.2196/51210.
PubMed 38900505
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Physical Activity's Relationship With Cancer and Cognition: A Pilot Randomized Trial
- ClinicalTrials.gov ID
- NCT03980626
- Acronym / sponsor ID
- SPARCC / 0091-19-FB
- Conditions
- Breast Cancer, Breast Neoplasm Female
- Keywords
- physical activity, exercise, cognition, brain health, breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 10 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Walking Intervention | Experimental | Behavioral: WalkingWalking participants will engage in the 3-times weekly walking program for 12 weeks. |
| Usual Care | No intervention | –Usual care participants will be offered two personalized exercise sessions with a trained exercise specialist after all post-intervention data have been collected. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WalkingAlso: Aerobic Exercise TrainingThe 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. | Behavioural | Walking Intervention |
Primary outcome
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.
7 secondary outcomes
Regional brain volume
Time frame: Baseline, Week 12
White matter structural integrity
Time frame: Baseline, Week 12
Resting state functional connectivity
Time frame: Baseline, Week 12
N2pc Amplitude
Time frame: Baseline, Week 12
Cardiorespiratory Fitness
Time frame: Baseline, Week 12
Cancer-related Fatigue
Time frame: Baseline, Week 12
Objective Activity Behavior
Time frame: Baseline, Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Derived from this study: PubMed 38900505Page LL, Fanning J, Phipps C, Berger A, Reed E, Ehlers D. Heart Rate Monitoring Among Breast Cancer Survivors: Quantitative Study of Device Agreement in a Community-Based Exercise Program. JMIR Cancer. 2024 Jun 20;10:e51210. doi: 10.2196/51210.
- Individual participant dataSharing planned: Yes. De-identified data will be available upon request as required by journal publishers during dissemination phase of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diane K Ehlers, PhD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking in people with Breast Cancer and Breast Neoplasm Female, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Executive Function (time frame: Baseline, Week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03980626, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2024.