Clinical trial NCT04816006: Breast Cancer, Reasoning, and Activity Intervention
Official title: Enhancing Cognitive Function in Breast Cancer Survivors Through Community-based Exercise Training
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-03-25
Enrollment: 160
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: PRIMARY OBJECTIVES:

I. Examine the effectiveness of a 6-month, community-based aerobic exercise intervention on multiple indicators of cognitive function in post-menopausal breast cancer survivors.

II. Gather information on the intervention's potential for scalability using the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework.

EXPLORATORY OBJECTIVE:

I. Explore potential moderators and mediators of the effects of aerobic exercise training on cognitive function.

II. Investigate the feasibility of urinary metabolites as biomarkers of overall diet patterns.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: 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 a gait assessment and magnetic resonance imaging (MRI), as well as wear an accelerometer throughout the study.

ARM II: Patients participate in up to 9 monthly classes/webinars. Patients also receive informational portable document format (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.

After completion of study intervention, patients are followed up with at 6 months.

Eligibility criteria: Inclusion Criteria

* 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
* 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 Criteria:

* 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
* 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

Primary outcomes:
measure: Change in inhibitory control
timeFrame: baseline (Month 0), post-intervention (month 6), follow up (month 12)
measure: Change in cognitive flexibility
timeFrame: baseline (Month 0), post-intervention (month 6), follow up (month 12)
measure: Change in executive function processing
timeFrame: baseline (Month 0), post-intervention (month 6), follow up (month 12)
measure: Change in short-term memory
timeFrame: baseline (Month 0), post-intervention (month 6), follow up (month 12)
measure: Change in verbal memory
timeFrame: baseline (Month 0), post-intervention (month 6), follow up (month 12)
measure: Change in working memory
timeFrame: baseline (Month 0), post-intervention (month 6), follow up (month 12)
measure: Change in brain volume
timeFrame: baseline (Month 0), post-intervention (month 6)
measure: Change in white matter integrity
timeFrame: baseline (Month 0), post-intervention (month 6)
measure: Change in resting state functional connectivity
timeFrame: baseline (Month 0), post-intervention (month 6)
measure: Change in self-reported cognitive function
timeFrame: baseline (Month 0), post-intervention (month 6), follow up (month 12)
measure: Reach
timeFrame: baseline (Month 0)
measure: Adoption
timeFrame: post-intervention (month 6)
measure: Change in Cardiorespiratory Fitness
timeFrame: baseline (Month 0), post-intervention (month 6), follow up (month 12)
measure: Change in Cancer-related Fatigue
timeFrame: baseline (Month 0), post-intervention (month 6), follow up (month 12)
measure: Implementation
timeFrame: post-intervention (month 6)
measure: Maintenance
timeFrame: follow up (month 12)
measure: Change in processing speed
timeFrame: baseline (Month 0), post-intervention (month 6), follow up (month 12)
measure: Change in attention
timeFrame: baseline (Month 0), post-intervention (month 6), follow up (month 12)
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Diane K. Ehlers, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: