A Study Of Movement And Memory After Breast Cancer
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 25-007121
Sponsor Protocol Number: 25-007121
About this study
The purpose of this study is to identify disparities in the effectiveness of a 6-month, community-based aerobic exercise intervention for improving neurocognitive function in Hispanic BCS (N=40) when compared with non-Hispanic White BCS in the partner trial.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria: Pre-Registration
Age ≥ 50 years at time of pre-registration visit according to participant report and/or clinical determination.
Self-identifies as Hispanic (any race)
First time, primary diagnosis of Stage I-IIIa breast cancer according to participant report and/or clinical determination.
Post-surgery and completed primary adjuvant treatment (i.e., surgery, chemotherapy, and/or radiation therapy) 3-36 months prior to pre-registration according to participant report and/or clinical determination.
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.
Self-reported ability to complete assessments by themselves or with assistance.
Exclusion Criteria: Pre-Registration
Stage 0 breast cancer diagnosis OR metastatic disease.
Currently receiving or <3 months since receiving chemotherapy or radiation therapy for cancer, or greater than 36 months post primary treatment.
Planned surgery during the intervention period.
Secondary cancer diagnosis (excluding non-invasive skin cancers, carcinoma-in-situ for any cancer)
Unable to regularly attend the study locations for intervention sessions and data collection.
Unwilling to return to enrolling institution for follow-up.
Self-reported inability to walk without assistance or devices.
Registration – Inclusion Criteria:
Age ≥ 50 years or older as confirmed via clinical determination.
Self-identifies as Hispanic (any race)
Able to provide medical record release to confirm eligibility.
First time, primary diagnosis of Stage I-IIIa breast cancer as confirmed via clinical determination.
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
No evidence of possible cognitive impairment as assessed using the Telephone Interview of Cognitive status [13-item modified version] (TICS-M; score >21)
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 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%
Ability to complete assessments by themselves or with assistance.
Agree to be randomized
Registration – Exclusion Criteria:
History of stroke, transient ischemic attack, other neurological disorders, or brain surgery involving tissue removal as confirmed via clinical determination
Clinically significant TICS-M score (<21) during baseline procedures
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)
Contraindications to functional magnetic resonance imaging (fMRI) in accordance with the Mayo Clinic Department of Radiology safety protocols.
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.
Enrolled in another physical activity program.
Unable to walk without assistance or devices.
Unwilling to complete study requirements.
Unwilling to be randomized to the exercise group or health education group.
Unable to regularly attend study locations for intervention sessions and data collection.
Unwilling to return to enrolling institution for follow-up.
Unable to complete the study in English or Spanish.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 6/25/2025. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Diane Ehlers, Ph.D. |
Contact us for the latest status |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available