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Exercise and Reasoning for Breast Cancer Survivors

This study is looking at whether a 24-week exercise program can improve thinking skills (like memory and attention) in women aged 50 and older who have survived breast cancer. Many survivors experience "chemo brain" or other cognitive (thinking) issues, which can affect daily life. This trial compares an Aerobic Exercise Training program, led by personal trainers, to a Health Education program with discussions and newsletters. Researchers want to see if exercise helps with cognitive flexibility, inhibitory control (the ability to control impulses), and executive function (higher-level thinking skills). The study aims to enroll 160 women who have completed their primary treatment for stage I-IIIa breast cancer.

Study design
This is an interventional study with 160 participants, comparing an exercise program to a health education program.
What's involved
If you join, you would participate in either a 24-week exercise program with supervised sessions or a 24-week health education program with classes/webinars. You would have assessments at the start, after 6 months, and again at 12 months.
Compensation
Not stated in the trial record.
Follow-up
Your cognitive function will be measured at 6 months (post-intervention) and again at 12 months (follow-up) after starting the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04816006

Breast Cancer, Reasoning, and Activity Intervention

Recruiting
NAAges 50+InterventionalSupportive care
Mayo Clinic
~160 participants
Updated 2026-07-31 on ClinicalTrials.gov
What's tested:Aerobic Exercise TrainingHealth Education (Active comparator)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in inhibitory control
Measured over baseline (Month 0), post-intervention (month 6), follow up (month 12)
+17 more outcomes measured

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

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
Arizona1

Study leadership

  • Diane K. Ehlers, Ph.D. · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Melissa Cole, MS
[email protected]
480-574-4052
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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
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
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

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
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

What this trial measures

  • Change in inhibitory controlbaseline (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 flexibilitybaseline (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 processingbaseline (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 memorybaseline (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 memorybaseline (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 memorybaseline (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 volumebaseline (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 integritybaseline (Month 0), post-intervention (month 6)

    Change in fractional anisotropy as measured by diffusion MRI.

  • Change in resting state functional connectivitybaseline (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 functionbaseline (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.

  • Reachbaseline (Month 0)

    Participation rate among eligible individuals contacted about the study.

  • Adoptionpost-intervention (month 6)

    Sociodemographics questionnaire to describe demographics characteristics and experience among personal trainers

  • Change in Cardiorespiratory Fitnessbaseline (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 Fatiguebaseline (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.

  • Implementationpost-intervention (month 6)

    Percent of session checklist items completed as intended

  • Maintenancefollow up (month 12)

    The number of participants who withdraw during the follow-up period.

  • Change in processing speedbaseline (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 attentionbaseline (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