Exercise Intervention After Cancer Treatment for Improving Health in Stage II-III Breast Cancer Survivors
Condition: Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage IIA Breast Cancer AJCC v8; Anatomic Stage IIB Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Anatomic Stage IIIB Breast Cancer AJCC v8; Anatomic Stage IIIC Breast Cancer AJCC v8; Cancer Survivor; Estrogen Receptor Positive; HER2/Neu Negative; Progesterone Receptor Positive; Prognostic Stage II Breast Cancer AJCC v8; Prognostic Stage IIA Breast Cancer AJCC v8; Prognostic Stage IIB Breast Cancer AJCC v8; Prognostic Stage III Breast Cancer AJCC v8; Prognostic Stage IIIA Breast Cancer AJCC v8; Prognostic Stage IIIB Breast Cancer AJCC v8; Prognostic Stage IIIC Breast Cancer AJCC v8; Sedentary Lifestyle
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Exercise Intervention; Informational Intervention; Laboratory Biomarker Analysis; Monitoring Device; Questionnaire Administration; Physical Performance Testing
Intervention type(s): Behavioral; Other; Other; Device; Other; Other
Intervention description(s): Complete exercise program; Receive written information on healthy exercise and diet recommendations; Blood tests; Wear Fitbit; Ancillary studies; Performance of physical tests
Other intervention name(s): Monitor; Physical Function Testing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care