The purpose of this study is to assess the feasibility of a 4-week intervention combining exercise and transcranial alternating current stimulation (Ex+tACS) in breast cancer survivors who report experiencing cancer-related cognitive impairment. Feasibility will be assessed by measuring participant retention, adherence, satisfaction with the intervention, and safety. The researchers will also examine pre-to-post intervention changes in attention, executive function, working memory, perceived cognitive function, and physical function before, after, and four weeks post intervention completion in the Ex+tACS group compared to a control group who will receive exercise and a placebo tACS condition (CON).
Diagnosed non-metastatic breast cancer (stages 0-3)
Completed primary breast cancer treatment (surgery, chemotherapy, radiation) for at least 3 months
Self-reported cognitive impairment after cancer treatment
Current participation in aerobic exercise for ≥60 min/wk
Contraindication or impairment that precludes the potential participant from exercise as defined by the American College of Sports Medicine
The presence of serious medical illnesses, metal implants, previous brain trauma, epilepsy or history of seizures, previous surgery to the head or spinal cord, or skin problems at the forehead area where the tACS electrodes will be applied
Uncontrolled cardiovascular disease
Parallel
Exercise + transcranial alternating current stimulation (Ex+tACS)
BehavioralThe Ex+tACS group will complete a four-week intervention consisting of 3 days/week of 30 minutes of aerobic exercise on a treadmill at a sustained moderate intensity, immediately followed by 15 min of tACS while completing the AX Continuous Performance Test (AX-CPT).
Control
BehavioralThe Control (CON) group will complete 30 minutes of aerobic exercise on the treadmill followed by the Sustained Attention-Continuous Performance Task (AX-CPT) with a sham tACS condition. After each session, both the EX+tACS and control participants will complete a questionnaire regarding experience with tACS.
Adherence
Adherence will be calculated based on the percentage of prescribed sessions attended and percentage of participants who complete the prescribed exercise and tACS sessions.
Retention
Retention will be determined by the number of enrolled breast cancer survivors who participate in the four-week intervention and complete post assessments.
Acceptability
Acceptability will be determined by the percentage of participants who report satisfaction with the intervention.
Safety (Adverse Events)
Safety (\<5% of serious adverse events) will be determined by the percentage of participants experiencing a serious adverse event related to the program.
Sustained attention
Researchers will assess pre- to post-intervention changes in sustained attention, measured by performance on the AX-Continuous Performance Test (AX-CPT).
Executive function
Researchers will assess pre- to post-intervention changes in executive function, measured by performance (time) on the Trail Making Test Part A (TMT-A) and Part B (TMT-B).
Inhibitory control
Researchers will assess pre- to post-intervention changes in inhibitory control, measured by performance on the Flanker Compatibility Task.
Working Memory
Researchers will assess pre- to post-intervention changes in working memory, measured by performance on the N-back and Backwards Counting tasks.
Body fat percentage
Researchers will assess pre- to post-intervention changes in body fat percentage measured via bioelectrical impedance analysis using the BIA-ACC (BioTekna) device.
Learning and Memory
Researchers will assess pre- to post-intervention changes in learning and memory, assessed by the California Verbal Learning Test.
Quality of Life (FACT-B)
Researchers will assess pre- to post-intervention changes in quality of life, measured by the Functional Assessment of Cancer Therapy - Breast. Scores range from 0-148, with higher scores indicating better quality of life.
Fatigue (FACIT-F)
Researchers will assess pre- to post-intervention changes in fatigue, measured by the Functional Assessment of Chronic Illness Therapy-Fatigue. Scores range from 0-52, with higher scores indicating less fatigue.
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Florida Atlantic University
Lead sponsor
Memorial Sloan Kettering Cancer Center
Collaborator
Florida Department of Health
Collaborator
