Breast Cancer, Reasoning, and Activity Intervention

Not Applicable

Recruiting

• 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
• Interventions: Other: Health Education (Active comparator); Behavioral: Aerobic Exercise Training

• Registration Number: NCT04816006
• Lead Sponsor: Mayo Clinic

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 in weeks 1-2, 2 sessions each week in weeks 3-4, 1 session each week in weeks 5-8, biweekly sessions across weeks 9-16, and monthly sessions 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 12 months.

Study Timeline

• Study First Submitted: 2021-02-26
• Study First Submitted QC: 2021-03-22
• Study First Posted: 2021-03-25
• Study Start: 2024-02-22
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-25
• Last Update Posted: 2024-10-29
• Primary Completion: 2027-04-30
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 160

Inclusion Criteria

Not provided

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Exclusion Criteria

• PRE-REGISTRATION: Individual who was pre- or peri-menopausal at the time of diagnosis with breast cancer
• 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 24 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm II (Health Education)	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.
Arm I (Aerobic Exercise)	Aerobic Exercise Training	Patients attend 3 weekly exercise sessions in weeks 1-2, 2 sessions each week in weeks 3-4, 1 session each week in weeks 5-8, biweekly sessions across weeks 9-16, and monthly sessions 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.

Primary Outcome Measures

Name	Time	Method
Adoption	post-intervention (month 6)	Sociodemographics questionnaire to describe demographics characteristics and experience among personal trainers
Maintenance	follow up (month 12)	The number of participants who withdraw during the follow-up period.
Change in executive function processing	baseline (Month 0), post-intervention (month 6), follow up (month 12)	Change in reaction time on Shifting Attention task, with lower values indicating greater cognitive flexibility
Change in short-term memory	baseline (Month 0), post-intervention (month 6), follow up (month 12)	Change in accuracy on Visual Memory task, with higher accuracy indicating greater short-term memory
Change in brain volume	baseline (Month 0), post-intervention (month 6)	Change in mean cortical thickness of brain regions of interest as measured by an anatomic MRI brain scan
Change in attention	baseline (Month 0), post-intervention (month 6), follow up (month 12)	Change in choice reaction time on Continuous Performance task, with lower values indicating greater sustained attention
Change in cognitive flexibility	baseline (Month 0), post-intervention (month 6), follow up (month 12)	Change in accuracy on Shifting Attention task, with higher values indicating greater cognitive flexibility
Change in working memory	baseline (Month 0), post-intervention (month 6), follow up (month 12)	Change in reaction time the 4-part Continuous Performance task, with lower values indicating greater working memory
Change in resting state functional connectivity	baseline (Month 0), post-intervention (month 6)	Change in within-network pairwise correlation estimates as measured using a multiband echo planar imaging (mb-EPI) functional MRI sequence
Implementation	post-intervention (month 6)	Percent of session checklist items completed as intended
Change in verbal memory	baseline (Month 0), post-intervention (month 6), follow up (month 12)	Change in number recalled on Hopkins Verbal Learning task, with higher values indicating greater verbal memory
Change in self-reported cognitive function	baseline (Month 0), post-intervention (month 6), follow up (month 12)	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.
Reach	baseline (Month 0)	Participation rate among eligible individuals contacted about the study.
Change in Cardiorespiratory Fitness	baseline (Month 0), post-intervention (month 6), follow up (month 12)	Change in Peak VO2 as measured by a modified Balke treadmill graded exercise test protocol.
Change in processing speed	baseline (Month 0), post-intervention (month 6), follow up (month 12)	Change in reaction time on Symbol Digit Coding task, with lower values indicating greater processing speed
Change in inhibitory control	baseline (Month 0), post-intervention (month 6), follow up (month 12)	Change in interference score on Stroop task, with positive values indicating greater inhibitory control.
Change in white matter integrity	baseline (Month 0), post-intervention (month 6)	Change in fractional anisotropy as measured by diffusion MRI.
Change in Cancer-related Fatigue	baseline (Month 0), post-intervention (month 6), follow up (month 12)	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.

Trial Locations

Locations (1)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States