Breast Cancer Clinical Trial

Study on Physical Activity’s Relationship With Cancer and Cognition

Summary

Aim 1: This pilot study tests the effects of aerobic exercise training on cognitive function in breast cancer survivors (BCS). To test aim 1, the investigators will randomize up to forty post-menopausal BCS (3-24 months post-treatment) to a 12-week walking intervention (n=20) or usual care (n=20). Walking participants will attend small group (n=3-5 BCS) sessions led by an exercise specialist 3 times weekly. Usual care participants will complete baseline and post-testing and be offered two sessions with an exercise specialist after all data have been collected. Aim 1 measures include accelerometry, neurocognitive testing, and patient-reported outcomes at baseline and post-intervention.

Aim 2: The investigators will generate preliminary data on clinical and biological correlates of exercise and cognition, including treatment protocol, cardiorespiratory fitness, brain structure and function, and cancer-related fatigue. To test aim 2, all participants will complete a fitness test, electrophysiology, and patient-reported outcomes at baseline and post-intervention. A subset of participants will also be invited to undergo magnetic resonance imaging (MRI).

Data will be analyzed using descriptive statistics and analysis of covariance, and effect sizes expressed as standard mean difference will be calculated.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Female
Post-menopausal at time of diagnosis
First, primary diagnosis of Stage I-IIIa breast cancer
Completed treatment 3-24 months prior to study start
Available to attend exercise sessions 3 times weekly for 12 weeks
No scheduled travel >7 consecutive days during the intervention
Agree to be randomized
Willingness to wear, charge, and sync Fitbit
English reading and speaking
Physician's clearance to exercise
Provide written informed consent

Exclusion Criteria:

Males
Pre- or peri-menopausal at the time of diagnosis
Stage 0 or metastatic disease
Currently receiving chemotherapy or radiation therapy
More than 24 months post-treatment
Scheduled to receive breast surgery
Second cancer diagnosis (excluding non-invasive skin cancers)
Self-report an average of ≥60 minutes of MVPA per week for the previous 6 months
Not cleared to exercise by a physician
Not available to attend 3 times weekly exercise sessions for 12 weeks
Out of town travel scheduled for >1 week during the intervention
Unwilling to complete baseline assessments
Unwilling to be randomized to the exercise or control group
Unwilling to wear, charge, and sync the Fitbit during the study period
Unable to read and speak in English
Unwilling to provide written informed consent to participate
Cognitive impairment prior to baseline assessment
History of stroke, transient ischemic attack, other neurological disorders, or brain surgery involving tissue removal

Study is for people with:

Breast Cancer

Estimated Enrollment:

30

Study ID:

NCT03980626

Recruitment Status:

Completed

Sponsor:

University of Nebraska

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

University of Nebraska Medical Center
Omaha Nebraska, 68198, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

30

Study ID:

NCT03980626

Recruitment Status:

Completed

Sponsor:


University of Nebraska

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider