Breast Cancer, Reasoning, and Activity Intervention

Overview

About this study

The purpose of this study is to test the effectiveness of aerobic exercise training, delivered in a community-based setting, for improving cognitive function in post-menopausal Breast Cancer Survivors (BCS).

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

- Able to provide medical record release to confirm eligibility

- First, primary diagnosis of Stage I-IIIa breast cancer

- Post-menopausal at the time of diagnosis

- Post-surgery and completed primary treatment (i.e., surgery, chemotherapy, and/or
radiation therapy) 3-24 months prior to enrollment

- No evidence of possible cognitive impairment as assessed using the Telephone Interview
of Cognitive status (TICS-M)

- Self-report 20+ minutes of exercise on 2 or fewer days per week within the previous
six months

- Receive physician's clearance to participate in an exercise program

- Ability to complete assessments by themselves or with assistance

Exclusion Criteria:

- Pre- or peri-menopausal at the time of diagnosis with breast cancer

- Stage 0 breast cancer diagnosis OR metastatic disease

- Currently receiving or <3 months since receiving chemotherapy or radiation therapy for
cancer, or greater than 24 months post primary treatment

- Planned surgery during the intervention period

- Second cancer diagnosis (excluding non-invasive skin cancers; including breast cancer
recurrence)

- 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

- Not able to provide physician re-clearance for exercise if required based upon
clinically significant baseline exercise test

- 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 or unwilling to continuously wear and regularly sync/charge an activity tracker
during the study period

- Unable to travel regularly to the study locations for intervention sessions and data
collection

- Unwilling to return to enrolling institution for follow-up

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 5/25/23. 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.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
.
CLS-20558432

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