The Women In Steady Exercise Research (WISER) Survivor Trial

The Women In Steady Exercise Research (WISER) Survivor Trial & Cost of Illness and Cost Effectiveness of Alternative Management Strategies

WISER Survivor is a one year weight loss and exercise study for sedentary breast cancer survivors who are overweight or obese with breast cancer related lymphedema. There will be four groups in this trial: exercise only, weight loss only, exercise and weight-loss combined, and a control group. The primary purpose of this study is to test the effects of these interventions on clinical lymphedema outcomes. Secondary outcomes include weight loss, breast cancer related biomarkers, and quality of life. To the extent that funding will be available, participants will be followed long term to examine effects on recurrence and mortality.

Inclusion Criteria:

• breast cancer survivor
• overweight or obese (BMI of 25 or greater)
• must have breast cancer related lymphedema
• at least 6 months post-treatment (e.g. surgery, chemotherapy, or radiotherapy) but there will be no upper limit on time elapsed from diagnosis
• the eligible age range will have no lower limit.
• currently free of cancer

Exclusion Criteria:

• medical conditions or medications that would prohibit participation in an exercise program or would negatively impact our ability to test our primary aims
• inability to walk for 6 minutes unaided
• extremely obese (body mass index greater or equal to 50 kg/m2)
• plans for additional (e.g. curative or reconstructive) surgery during the study period
• self-report of weight-lifting within the past year
• already engaging in 3 or more times weekly aerobic activity of moderate intensity
• planning to move away from the area over the next year
• current use of weight loss medication (OTC or prescription)
• self-report of alcohol or substance abuse within the past 12 months, including at-risk drinking (current consumption of more than 14 alcoholic drinks per week)
• weight loss of greater than 10 % in the past 3 months
• history of bariatric surgery
• women who are pregnant