Breast CancerBRAINNCT04816006
Breast Cancer, Reasoning, and Activity Intervention
A study testing Aerobic Exercise Training and Health Education (Active comparator) in people with Breast Cancer and Breast Neoplasms, run by Mayo Clinic at 1 site in United States.
Trial summary
This phase II trial tests whether an exercise intervention works to improve cognitive function in breast cancer survivors. Many breast cancer survivors report cancer-related cognitive impairment, which this has recently become a priority in clinical research due to its dramatic impact on daily functioning, quality of… Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Neoplasms, Anatomic Stage I Breast Cancer AJCC v8
- What is being tested?
- Aerobic Exercise Training and Health Education (Active comparator)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2024to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PRE-REGISTRATION: Age ≥50 years at time of pre-registration visit according to participant report and/or clinical determination
- PRE-REGISTRATION: First, primary diagnosis of stage I-IIIa breast cancer according to participant report and/or clinical determination
- PRE-REGISTRATION: Post-surgery and completed primary treatment (i.e., surgery, chemotherapy, and/or radiation therapy) 3-60 months prior to registration according to participant report and/or clinical determination
- PRE-REGISTRATION: Sedentary except for casual lifestyle recreation defined as self-reporting no more than 90 minutes per week of moderate-intensity aerobic exercise within the last 6 months
- PRE-REGISTRATION: Self-reported ability to complete assessments by themselves or with assistance
- REGISTRATION: Age ≥50 years as confirmed via clinical determination
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- REGISTRATION: Able to provide medical record release to confirm eligibility
- REGISTRATION: First, primary diagnosis of stage I-IIIa breast cancer as confirmed via clinical determination
- REGISTRATION: Post-surgery and completed primary treatment (i.e., surgery, chemotherapy, and/or radiation therapy) 3-60 months prior to pre-registration as confirmed via clinical determination
- REGISTRATION: No evidence of possible cognitive impairment as assessed using the Telephone Interview of Cognitive status (13-item modified version) (TICS-M; score > 21) NOTE: Only individuals who pass the TICS-M during pre-registration will be invited to participate in the urine substudy
- REGISTRATION: Receive physician's clearance to participate in an exercise program
- NOTE: Individuals with conditions/diagnoses deemed important by the primary investigator will be required to provide clearance for exercise from their cardiologist. Example conditions include:
- History of major multiple myocardial infarctions (MI)
- Recent electrocardiogram (ECG) changes or recent MI
- Resting or unstable angina
- Significant multivessel coronary occlusion (≥ 70%) on angiography
- Uncontrolled and/or serious arrhythmias
- 3rd degree heart block
- Acute congestive heart failure or ejection fraction < 30%
- REGISTRATION: Ability to complete assessments by themselves or with assistance
Who cannot join
- PRE-REGISTRATION: Stage 0 breast cancer diagnosis OR metastatic disease
- PRE-REGISTRATION: Currently receiving or < 3 months since receiving chemotherapy or radiation therapy for cancer, or greater than 60 months post primary treatment
- PRE-REGISTRATION: Planned surgery during the intervention period
- PRE-REGISTRATION: Second cancer diagnosis (excluding non-invasive skin cancers or carcinoma-in-situ for any cancer)
- PRE-REGISTRATION: Unable to travel regularly to the study locations for intervention sessions and data collection
- PRE-REGISTRATION: Unwilling to return to enrolling institution for follow-up
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- PRE-REGISTRATION: Self-reported inability to walk without assistance or devices
- REGISTRATION: History of stroke, transient ischemic attack, other neurological disorders, or brain surgery involving tissue removal as confirmed via clinical determination
- REGISTRATION: Clinically significant TICS-M score (< 21) during baseline procedures
- REGISTRATION: Not able to provide physician re-clearance for exercise if required based upon clinically significant baseline exercise test (as determined by ECG and blood pressure monitoring)
- REGISTRATION: Contraindications to functional magnetic resonance imaging (fMRI) in accordance with the Mayo Clinic Department of Radiology safety protocols
- REGISTRATION: Clinically significant MRI scan as determined by physician review in which the following is advised via radiologist overread: remarkable/abnormal limited diagnostic brain image with recommended medical follow-up
- REGISTRATION: Enrolled in another physical activity program
- REGISTRATION: Unable to walk without assistance or devices
- REGISTRATION: Unwilling to complete study requirements
- REGISTRATION: Unwilling to be randomized to the exercise group or health education group
- REGISTRATION: Unable or unwilling to continuously wear and regularly sync/charge an activity tracker during the study period
- REGISTRATION: Unable to travel regularly to the study locations for intervention sessions and data collection
- REGISTRATION: Unwilling to return to enrolling institution for follow-up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Arizona
Phoenix, Arizona, 85054
Melissa Cole, MS, 480-574-4052, cole.melissa@mayo.edu
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
About this study
Official title: Enhancing Cognitive Function in Breast Cancer Survivors Through Community-based Exercise Training
This phase II trial tests whether an exercise intervention works to improve cognitive function in breast cancer survivors. Many breast cancer survivors report cancer-related cognitive impairment, which this has recently become a priority in clinical research due to its dramatic impact on daily functioning, quality of life, and long-term health. Aerobic exercise has the potential to improve cognitive function and brain health in older adults and is recommended as a safe, tolerable, and accessible complementary therapy for breast cancer survivors. This study aims to understand the effects of physical activity compared with health education on memory, attention, and brain health in women with breast cancer. Study findings may help researchers design more programs that can improve memory, attention, and brain health in other women with breast cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- Examine the effectiveness of a 6-month, community-based aerobic exercise intervention on multiple indicators of cognitive function in breast cancer survivors (BCS) aged 50 and older (N=160).
II. Gather information on the intervention's potential for scalability using the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework.
EXPLORATORY OBJECTIVES:
- Explore potential moderators and mediators of the effects of aerobic exercise training on cognitive function.
II. Investigate the feasibility of urinary metabolites as biomarkers of overall diet patterns.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients attend 3 weekly exercise sessions over 60-75 minutes per week in weeks 1-2, 2 sessions over 70-70 each week in weeks 3-4, 1 session over 90-120 minutes each week in weeks 5-8, biweekly sessions over 120-150 per week across weeks 9-16, and monthly sessions over at least 150 minutes per week in weeks 17-24 for a total of 20 supervised sessions. Patients undergo a gait assessment and magnetic resonance imaging (MRI), as well as wear an accelerometer throughout the study.
ARM II: Patients participate in up to 9 monthly classes/webinars. Patients also receive informational portable document format (pdfs), videos, and/or podcasts, and a one-year subscription to the Mayo Clinic Health Letter. Patients undergo a gait assessment and MRI, as well as wear an accelerometer throughout the study.
After completion of study intervention, patients are followed up with at 6 months.
- Conditions
- Breast Cancer, Breast Neoplasms, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Cancer-related Cognitive Dysfunction
- Being tested
- Aerobic Exercise Training, Health Education (Active comparator)
- 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.
Aerobic Exercise TrainingBehavioural
Breast cancer survivors in the intervention group will participate in a 24-week moderate intensity exercise program led by community-based fitness center personal trainers. Individually-tailored exercise prescriptions will be developed based upon each participant's baseline maximal graded exercise test (heart rate corresponding with %VO2 peak) and symptom limitation. Sessions will be progressive in nature such that the volume of exercise increases across weeks. Treadmill walking is the primary mode of exercise. However, participants will be permitted to use other cardiovascular equipment (e.g., elliptical machines, stationary bicycles) as prescribed by their exercise trainer. The trainer will supervise three weekly exercise sessions in Weeks 1-2, two in Weeks 3-4, one in Weeks 5-8, biweekly across weeks 9-16, and monthly in Weeks 17-24 (N=20 supervised sessions).
Health Education (Active comparator)Other
Also called Control Group
Breast cancer survivors in the Health Education group will participate in education sessions with a health educator and receive monthly newsletters/webinars (N=20 total contacts) across 24 weeks. The program will include cancer support and discussion of cancer-related wellness topics (e.g., stress management, coping). Control group participants will be offered a 6-month fitness center membership upon study completion.
| Study group | Role | What they receive |
|---|---|---|
| Arm I (Aerobic Exercise) | Experimental | Patients attend 3 weekly exercise sessions over 60-75 minutes per week in weeks 1-2, 2 sessions over 70-70 each week in weeks 3-4, 1 session over 90-120 minutes each week in weeks 5-8, biweekly sessions over 120-150 per week across weeks 9-16, and monthly sessions over at least 150 minutes per week in weeks 17-24 for a total of 20 supervised sessions. Patients undergo MRI and wear an accelerometer throughout the study. Receives: Behavioral: Aerobic Exercise Training |
| Arm II (Health Education) | Active comparator | Patients participate in up to 9 monthly classes/webinars. Patients also receive informational pdfs, videos, and/or podcasts, and a one-year subscription to the Mayo Clinic Health Letter. Patients undergo a gait assessment and MRI, as well as wear an accelerometer throughout the study. Receives: Other: Health Education (Active comparator) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in inhibitory control
Change in interference score on Stroop task, with positive values indicating greater inhibitory control.
Measured: baseline (Month 0), post-intervention (month 6), follow up (month 12)
Change in cognitive flexibility
Change in accuracy on Shifting Attention task, with higher values indicating greater cognitive flexibility
Measured: baseline (Month 0), post-intervention (month 6), follow up (month 12)
Change in executive function processing
Change in reaction time on Shifting Attention task, with lower values indicating greater cognitive flexibility
Measured: baseline (Month 0), post-intervention (month 6), follow up (month 12)
Change in short-term memory
Change in accuracy on Visual Memory task, with higher accuracy indicating greater short-term memory
Measured: baseline (Month 0), post-intervention (month 6), follow up (month 12)
Change in verbal memory
Change in number recalled on Hopkins Verbal Learning task, with higher values indicating greater verbal memory
Measured: baseline (Month 0), post-intervention (month 6), follow up (month 12)
Change in working memory
Change in reaction time the 4-part Continuous Performance task, with lower values indicating greater working memory
Measured: baseline (Month 0), post-intervention (month 6), follow up (month 12)
Change in brain volume
Change in mean cortical thickness of brain regions of interest as measured by an anatomic MRI brain scan
Measured: baseline (Month 0), post-intervention (month 6)
Change in white matter integrity
Change in fractional anisotropy as measured by diffusion MRI.
Measured: baseline (Month 0), post-intervention (month 6)
Change in resting state functional connectivity
Change in within-network pairwise correlation estimates as measured using a multiband echo planar imaging (mb-EPI) functional MRI sequence
Measured: baseline (Month 0), post-intervention (month 6)
Change in self-reported cognitive function
The perceived cognitive impairments subscale of the Functional Assessment in Cancer Therapy - Cognition (FACT-Cog) will be used to measure self-reported cognition. Scores range from 0-72, with higher scores indicating better cognitive function.
Measured: baseline (Month 0), post-intervention (month 6), follow up (month 12)
Reach
Participation rate among eligible individuals contacted about the study.
Measured: baseline (Month 0)
Adoption
Sociodemographics questionnaire to describe demographics characteristics and experience among personal trainers
Measured: post-intervention (month 6)
Change in Cardiorespiratory Fitness
Change in Peak VO2 as measured by a modified Balke treadmill graded exercise test protocol.
Measured: baseline (Month 0), post-intervention (month 6), follow up (month 12)
Change in 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 (Month 0), post-intervention (month 6), follow up (month 12)
Implementation
Percent of session checklist items completed as intended
Measured: post-intervention (month 6)
Maintenance
The number of participants who withdraw during the follow-up period.
Measured: follow up (month 12)
Change in processing speed
Change in reaction time on Symbol Digit Coding task, with lower values indicating greater processing speed
Measured: baseline (Month 0), post-intervention (month 6), follow up (month 12)
Change in attention
Change in choice reaction time on Continuous Performance task, with lower values indicating greater sustained attention
Measured: baseline (Month 0), post-intervention (month 6), follow up (month 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start22 Feb 2024
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
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 Mayo ClinicThe 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Diane K. Ehlers, Ph.D., Mayo Clinic
- Investigators
- Diane K. Ehlers, Ph.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04816006
- Sponsor's protocol ID
- MC231001
- Other IDs
- 23-000020, 852-20-FB, R37CA252060
- Acronym
- BRAIN
- Status last verified
- Sep 2026
- First submitted
- 26 Feb 2021
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Although the final dataset will not include identifying information, there is still a possibility of deductive disclosure of identity. Therefore, data will not be shared via an NIH or approved public repository; however, we will share de-identified data as required for publication in scientific journals and with outside collaborators and scientists upon request.
Publications
Ehlers DK, Austin JD, Ernst B, Page LL, Ofori E, Porter GC, Fanning J, Hickman G, McKim P, Cole M, Donaldson M, Braden BB, Kunze KL, Butterfield RJ, Baxter LC, Ahles TA, Estabrooks P. Enhancing cognitive function in breast cancer survivors through community-based aerobic exercise training: protocol for a Hybrid Type I effectiveness-implementation study employing a randomised controlled design. BMJ Open. 2025 Jul 13;15(7):e104378. doi: 10.1136/bmjopen-2025-104378.
PubMed 40659404
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Cognitive Function in Breast Cancer Survivors Through Community-based Exercise Training
- ClinicalTrials.gov ID
- NCT04816006
- Acronym / sponsor ID
- BRAIN / MC231001
- Conditions
- Breast Cancer, Breast Neoplasms, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Cancer-related Cognitive Dysfunction
- Keywords
- physical activity, exercise, cognition, brain health, breast cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 22 Feb 2024 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 25 Mar 2021 (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 phase II trial tests whether an exercise intervention works to improve cognitive function in breast cancer survivors. Many breast cancer survivors report cancer-related cognitive impairment, which this has recently become a priority in clinical research due to its dramatic impact on daily functioning, quality of life, and long-term health. Aerobic exercise has the potential to improve cognitive function and brain health in older adults and is recommended as a safe, tolerable, and accessible complementary therapy for breast cancer survivors. This study aims to understand the effects of physical activity compared with health education on memory, attention, and brain health in women with breast cancer. Study findings may help researchers design more programs that can improve memory, attention, and brain health in other women with breast cancer.
Detailed description
PRIMARY OBJECTIVES:
- Examine the effectiveness of a 6-month, community-based aerobic exercise intervention on multiple indicators of cognitive function in breast cancer survivors (BCS) aged 50 and older (N=160).
II. Gather information on the intervention's potential for scalability using the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework.
EXPLORATORY OBJECTIVES:
- Explore potential moderators and mediators of the effects of aerobic exercise training on cognitive function.
II. Investigate the feasibility of urinary metabolites as biomarkers of overall diet patterns.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients attend 3 weekly exercise sessions over 60-75 minutes per week in weeks 1-2, 2 sessions over 70-70 each week in weeks 3-4, 1 session over 90-120 minutes each week in weeks 5-8, biweekly sessions over 120-150 per week across weeks 9-16, and monthly sessions over at least 150 minutes per week in weeks 17-24 for a total of 20 supervised sessions. Patients undergo a gait assessment and magnetic resonance imaging (MRI), as well as wear an accelerometer throughout the study.
ARM II: Patients participate in up to 9 monthly classes/webinars. Patients also receive informational portable document format (pdfs), videos, and/or podcasts, and a one-year subscription to the Mayo Clinic Health Letter. Patients undergo a gait assessment and MRI, as well as wear an accelerometer throughout the study.
After completion of study intervention, patients are followed up with at 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (Aerobic Exercise) | Experimental | Behavioral: Aerobic Exercise TrainingPatients attend 3 weekly exercise sessions over 60-75 minutes per week in weeks 1-2, 2 sessions over 70-70 each week in weeks 3-4, 1 session over 90-120 minutes each week in weeks 5-8, biweekly sessions over 120-150 per week across weeks 9-16, and monthly sessions over at least 150 minutes per week in weeks 17-24 for a total of 20 supervised sessions. Patients undergo MRI and wear an accelerometer throughout the study. |
| Arm II (Health Education) | Active comparator | Other: Health Education (Active comparator)Patients participate in up to 9 monthly classes/webinars. Patients also receive informational pdfs, videos, and/or podcasts, and a one-year subscription to the Mayo Clinic Health Letter. Patients undergo a gait assessment and MRI, as well as wear an accelerometer throughout the study. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- PRE-REGISTRATION: Age ≥50 years at time of pre-registration visit according to participant report and/or clinical determination
- PRE-REGISTRATION: First, primary diagnosis of stage I-IIIa breast cancer according to participant report and/or clinical determination
- PRE-REGISTRATION: Post-surgery and completed primary treatment (i.e., surgery, chemotherapy, and/or radiation therapy) 3-60 months prior to registration according to participant report and/or clinical determination
- PRE-REGISTRATION: Sedentary except for casual lifestyle recreation defined as self-reporting no more than 90 minutes per week of moderate-intensity aerobic exercise within the last 6 months
- PRE-REGISTRATION: Self-reported ability to complete assessments by themselves or with assistance
Key exclusion criteria (19 listed)
- PRE-REGISTRATION: Stage 0 breast cancer diagnosis OR metastatic disease
- PRE-REGISTRATION: Currently receiving or < 3 months since receiving chemotherapy or radiation therapy for cancer, or greater than 60 months post primary treatment
- PRE-REGISTRATION: Planned surgery during the intervention period
- PRE-REGISTRATION: Second cancer diagnosis (excluding non-invasive skin cancers or carcinoma-in-situ for any cancer)
- PRE-REGISTRATION: Unable to travel regularly to the study locations for intervention sessions and data collection
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 |
|---|---|---|
| Aerobic Exercise TrainingBreast cancer survivors in the intervention group will participate in a 24-week moderate intensity exercise program led by community-based fitness center personal trainers. Individually-tailored exercise prescriptions will be developed based upon each participant's baseline maximal graded exercise test (heart rate corresponding with %VO2 peak) and symptom limitation. Sessions will be progressive in nature such that the volume of exercise increases across weeks. Treadmill walking is the primary mode of exercise. However, participants will be permitted to use other cardiovascular equipment (e.g., elliptical machines, stationary bicycles) as prescribed by their exercise trainer. The trainer will supervise three weekly exercise sessions in Weeks 1-2, two in Weeks 3-4, one in Weeks 5-8, biweekly across weeks 9-16, and monthly in Weeks 17-24 (N=20 supervised sessions). | Behavioural | Arm I (Aerobic Exercise) |
| Health Education (Active comparator)Also: Control GroupBreast cancer survivors in the Health Education group will participate in education sessions with a health educator and receive monthly newsletters/webinars (N=20 total contacts) across 24 weeks. The program will include cancer support and discussion of cancer-related wellness topics (e.g., stress management, coping). Control group participants will be offered a 6-month fitness center membership upon study completion. | Other | Arm II (Health Education) |
Primary outcome
Change in inhibitory control
Time frame: baseline (Month 0), post-intervention (month 6), follow up (month 12)
Change in interference score on Stroop task, with positive values indicating greater inhibitory control.
Change in cognitive flexibility
Time frame: baseline (Month 0), post-intervention (month 6), follow up (month 12)
Change in accuracy on Shifting Attention task, with higher values indicating greater cognitive flexibility
Change in executive function processing
Time frame: baseline (Month 0), post-intervention (month 6), follow up (month 12)
Change in reaction time on Shifting Attention task, with lower values indicating greater cognitive flexibility
Change in short-term memory
Time frame: baseline (Month 0), post-intervention (month 6), follow up (month 12)
Change in accuracy on Visual Memory task, with higher accuracy indicating greater short-term memory
Change in verbal memory
Time frame: baseline (Month 0), post-intervention (month 6), follow up (month 12)
Change in number recalled on Hopkins Verbal Learning task, with higher values indicating greater verbal memory
Change in working memory
Time frame: baseline (Month 0), post-intervention (month 6), follow up (month 12)
Change in reaction time the 4-part Continuous Performance task, with lower values indicating greater working memory
Change in brain volume
Time frame: baseline (Month 0), post-intervention (month 6)
Change in mean cortical thickness of brain regions of interest as measured by an anatomic MRI brain scan
Change in white matter integrity
Time frame: baseline (Month 0), post-intervention (month 6)
Change in fractional anisotropy as measured by diffusion MRI.
Change in resting state functional connectivity
Time frame: baseline (Month 0), post-intervention (month 6)
Change in within-network pairwise correlation estimates as measured using a multiband echo planar imaging (mb-EPI) functional MRI sequence
Change in self-reported cognitive function
Time frame: baseline (Month 0), post-intervention (month 6), follow up (month 12)
The perceived cognitive impairments subscale of the Functional Assessment in Cancer Therapy - Cognition (FACT-Cog) will be used to measure self-reported cognition. Scores range from 0-72, with higher scores indicating better cognitive function.
Reach
Time frame: baseline (Month 0)
Participation rate among eligible individuals contacted about the study.
Adoption
Time frame: post-intervention (month 6)
Sociodemographics questionnaire to describe demographics characteristics and experience among personal trainers
Change in Cardiorespiratory Fitness
Time frame: baseline (Month 0), post-intervention (month 6), follow up (month 12)
Change in Peak VO2 as measured by a modified Balke treadmill graded exercise test protocol.
Change in Cancer-related Fatigue
Time frame: baseline (Month 0), post-intervention (month 6), follow up (month 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.
Implementation
Time frame: post-intervention (month 6)
Percent of session checklist items completed as intended
Maintenance
Time frame: follow up (month 12)
The number of participants who withdraw during the follow-up period.
Change in processing speed
Time frame: baseline (Month 0), post-intervention (month 6), follow up (month 12)
Change in reaction time on Symbol Digit Coding task, with lower values indicating greater processing speed
Change in attention
Time frame: baseline (Month 0), post-intervention (month 6), follow up (month 12)
Change in choice reaction time on Continuous Performance task, with lower values indicating greater sustained attention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Background: PubMed 40659404Ehlers DK, Austin JD, Ernst B, Page LL, Ofori E, Porter GC, Fanning J, Hickman G, McKim P, Cole M, Donaldson M, Braden BB, Kunze KL, Butterfield RJ, Baxter LC, Ahles TA, Estabrooks P. Enhancing cognitive function in breast cancer survivors through community-based aerobic exercise training: protocol for a Hybrid Type I effectiveness-implementation study employing a randomised controlled design. BMJ Open. 2025 Jul 13;15(7):e104378. doi: 10.1136/bmjopen-2025-104378.
- Mayo Clinic Clinical Trials: Breast Cancer, Reasoning, and Activity InterventionLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Although the final dataset will not include identifying information, there is still a possibility of deductive disclosure of identity. Therefore, data will not be shared via an NIH or approved public repository; however, we will share de-identified data as required for publication in scientific journals and with outside collaborators and scientists upon request.
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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.
Diane K. Ehlers, Ph.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise Training and Health Education (Active comparator) in people with Breast Cancer and Breast Neoplasms, run by Mayo Clinic 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 20 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 8 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melissa Cole, MS (480-574-4052, cole.melissa@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in inhibitory control (time frame: baseline (Month 0), post-intervention (month 6), follow up (month 12)). The study lists 18 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 NCT04816006, 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 8 Sep 2026.