Breast Cancer, Reasoning, and Activity Intervention

NCT04816006 | Recruiting

• 5 other identifiers: MC23100123-000020852-20-FBR37CA252060NCI-2021-09939
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

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

Keywords

physical activity; exercise; cognition; brain health; breast cancer

Outcome Measures

Primary Outcomes (18)

• Change in inhibitory control

  Change in interference score on Stroop task, with positive values indicating greater inhibitory control.

  baseline (Month 0), post-intervention (month 6), follow up (month 12)

• Change in cognitive flexibility

  Change in accuracy on Shifting Attention task, with higher values indicating greater cognitive flexibility

  baseline (Month 0), post-intervention (month 6), follow up (month 12)

• Change in executive function processing

  Change in reaction time on Shifting Attention task, with lower values indicating greater cognitive flexibility

  baseline (Month 0), post-intervention (month 6), follow up (month 12)

• Change in short-term memory

  Change in accuracy on Visual Memory task, with higher accuracy indicating greater short-term memory

  baseline (Month 0), post-intervention (month 6), follow up (month 12)

• Change in verbal memory

  Change in number recalled on Hopkins Verbal Learning task, with higher values indicating greater verbal memory

  baseline (Month 0), post-intervention (month 6), follow up (month 12)

• Change in working memory

  Change in reaction time the 4-part Continuous Performance task, with lower values indicating greater working memory

  baseline (Month 0), post-intervention (month 6), follow up (month 12)

• Change in brain volume

  Change in mean cortical thickness of brain regions of interest as measured by an anatomic MRI brain scan

  baseline (Month 0), post-intervention (month 6)

• Change in white matter integrity

  Change in fractional anisotropy as measured by diffusion MRI.

  baseline (Month 0), post-intervention (month 6)

• Change in resting state functional connectivity

  Change in within-network pairwise correlation estimates as measured using a multiband echo planar imaging (mb-EPI) functional MRI sequence

  baseline (Month 0), post-intervention (month 6)

• Change in self-reported cognitive function

  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.

  baseline (Month 0), post-intervention (month 6), follow up (month 12)

• Reach

  Participation rate among eligible individuals contacted about the study.

  baseline (Month 0)

• Adoption

  Sociodemographics questionnaire to describe demographics characteristics and experience among personal trainers

  post-intervention (month 6)

• Change in Cardiorespiratory Fitness

  Change in Peak VO2 as measured by a modified Balke treadmill graded exercise test protocol.

  baseline (Month 0), post-intervention (month 6), follow up (month 12)

• Change in Cancer-related Fatigue

  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.

  baseline (Month 0), post-intervention (month 6), follow up (month 12)

• Implementation

  Percent of session checklist items completed as intended

  post-intervention (month 6)

• Maintenance

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

  follow up (month 12)

• Change in processing speed

  Change in reaction time on Symbol Digit Coding task, with lower values indicating greater processing speed

  baseline (Month 0), post-intervention (month 6), follow up (month 12)

• Change in attention

  Change in choice reaction time on Continuous Performance task, with lower values indicating greater sustained attention

  baseline (Month 0), post-intervention (month 6), follow up (month 12)

Study Arms (2)

Arm I (Aerobic Exercise)

EXPERIMENTAL

Patients attend 3 weekly exercise sessions over 60-75 minutes per week in weeks 1-2, 2 sessions over 70-70 each week in weeks 3-4, 1 session over 90-120 minutes each week in weeks 5-8, biweekly sessions over 120-150 per week across weeks 9-16, and monthly sessions over at least 150 minutes per week in weeks 17-24 for a total of 20 supervised sessions. Patients undergo MRI and wear an accelerometer throughout the study.

Behavioral: Aerobic Exercise Training

Arm II (Health Education)

ACTIVE COMPARATOR

Patients participate in up to 9 monthly classes/webinars. Patients also receive informational pdfs, videos, and/or podcasts, and a one-year subscription to the Mayo Clinic Health Letter. Patients undergo a gait assessment and MRI, as well as wear an accelerometer throughout the study.

Other: Health Education (Active comparator)

Interventions

Aerobic Exercise Training BEHAVIORAL

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).

Arm I (Aerobic Exercise)

Health Education (Active comparator) OTHER

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.

Also known as: Control Group

Arm II (Health Education)

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic in Arizona

Phoenix, Arizona, 85054, United States

RECRUITING

Related Publications (1)

• Ehlers DK, Austin JD, Ernst B, Page LL, Ofori E, Porter GC, Fanning J, Hickman G, McKim P, Cole M, Donaldson M, Braden BB, Kunze KL, Butterfield RJ, Baxter LC, Ahles TA, Estabrooks P. Enhancing cognitive function in breast cancer survivors through community-based aerobic exercise training: protocol for a Hybrid Type I effectiveness-implementation study employing a randomised controlled design. BMJ Open. 2025 Jul 13;15(7):e104378. doi: 10.1136/bmjopen-2025-104378.

  PMID: 40659404 DERIVED

Related Links

• Mayo Clinic Clinical Trials: Breast Cancer, Reasoning, and Activity Intervention

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Diane K. Ehlers, Ph.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa Cole, MS

CONTACT

480-574-4052; cole.melissa@mayo.edu

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: March 25, 2021
• Study Start: February 22, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be shared via scientific journals at the time of publication and with outside collaborators before publication.
• Access Criteria: We will make data available to researchers who agree to use the data only for research purposes, protect the data using secure computer technologies, and destroy the data after relevant analyses are completed and manuscripts published.

Locations

US (1)