NCT04816006 · Mayo Clinic
Breast Cancer, Reasoning, and Activity Intervention
(BRAIN)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Aerobic Exercise Training
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).
OTHER
Health Education (Active comparator)
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.
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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) 3-36 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
- 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) 3-36 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
Exclusion criteria
- 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 36 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
- 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
Where
- Phoenix, Arizona
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 12, 2026 · Source of record for eligibility and locations