This pilot trial studies how well exercise intervention after cancer treatment works in improving physical activity in stage II-III breast cancer survivors. An exercise intervention may promote regular physical activity.
PRIMARY OBJECTIVES: I. Estimate the adherence rate of the experimental exercise program, and deem as feasible if at least 80% of participants complete 80% or more of a 12-week, 180 minute aerobic+resistance training program that combines structured, individualized onsite exercise at the Fred Hutch Prevention Center with at-home exercise. II. Identify up to 5 circulating micro ribonucleic acid (c-miRNA) biomarkers that show the largest differential change from baseline when comparing levels in the exercise program to those in the Fitbit-activity control condition. SECONDARY OBJECTIVES: I. Explore associations between changes in miRNAs and serum biomarkers (IL-6, lipids, adiponectin and leptin, C-reactive protein \[CRP\]) and physiological outcomes (resting heart rate, blood pressure, 1 repetition max, 6 minute walk, timed up and go test) of the exercise program. II. Explore changes in the patient-reported outcomes (PRO) in response to the exercise intervention relative to the control group, and finalize measures to use in the design of the phase III clinical trial based on descriptive changes from baseline to follow-ups in the intervention versus (vs.) control groups. OUTLINE: Participants are randomized into 1 of 2 arms. ARM 0: Participants wear Fitbit and receive written information on healthy exercise and diet recommendations. ARM 1: Participants complete exercise program including aerobic and resistance exercises over 60 minutes 3 times per week for 12 weeks. Exercise is supervised all 3 times during weeks 1-2. During weeks 3-12, exercise is supervised 2 times a week, with home-based coaching for an additional 60 minutes a week.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
20
Complete exercise program
Receive written information on healthy exercise and diet recommendations
Blood tests
Wear Fitbit
Ancillary studies
Performance of physical tests
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Adherence
Will assess the percent of expected onsite sessions attended by participants as determined by Prevention Center attendance log.
Time frame: Up to 26 weeks
Differential micro ribonucleic acid expression
Will compare between arms. Descriptive statistics will be provided. Will calculate the log-fold change between baseline measure and post-baseline measure, and the difference in the log-fold change will be calculated between the two arms.
Time frame: At baseline, 13, and 26 weeks
Percent of expected home exercise sessions completed as determined by the home exercise logs for those choosing to not come in for a third weekly session
Time frame: Up to 26 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.