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

Phase 3
Open (Enrolling)

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Trial Information

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

Inclusion Criteria:

- breast cancer survivor

- overweight or obese (BMI of 25 or greater)

- must have breast cancer related lymphedema

- at least 2 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 or upper 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

Clinical lymphedema exacerbation rate

Outcome Description:

Lymphedema outcomes include: incident events requiring medical care for lymphedema (e.g. flare-ups or cellulitic infections), arm swelling in the affected limb (Interlimb volume differences), and pain & lymphedema symptoms (number and severity)

Outcome Time Frame:

Baseline, 6, and 12 months

Safety Issue:


Principal Investigator

Kathryn H. Schmitz, MPH,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pennsylvania


United States: Institutional Review Board

Study ID:

U54-CA 155850



Start Date:

January 2012

Completion Date:

June 2016

Related Keywords:

  • Lymphedema
  • Lymphedema
  • Strength training intervention
  • Weight loss intervention
  • Breast cancer recurrence
  • Cost Effectiveness
  • Lymphedema



The University of Pennsylvania TREC Survivorship Center/ Perelman School of MedicinePhiladelphia, Pennsylvania  19104