Strategic recruitment of an ethnically diverse cohort of overweight survivors of breast cancer with lymphedema.

BACKGROUND: Black women are more likely to experience adverse effects from cancer treatment such as lymphedema. Thus, black women may particularly benefit from research regarding interventions to improve lymphedema. Herein, the authors report the challenges and strategies related to the recruitment of minority survivors of breast cancer and to the recruitment of survivors of breast cancer with lymphedema into the Women In Steady Exercise Research (WISER) Survivor Clinical Trial. METHODS: Subjects for this community-based trial were recruited from the Philadelphia area through active (mailings) and passive (printed materials and Web site) recruitment strategies. In addition, education sessions coordinated through partner hospitals in communities with a predominantly minority population were conducted to increase awareness of lymphedema in survivors of breast cancer. Women who were interested in the study were screened for lymphedema via telephone questionnaire and invited to see a study-related certified lymphedema therapist to confirm the presence of lymphedema. RESULTS: Screening was conducted among 2295 women: 628 were eligible, 450 consented, and 351 were randomized. Minority women comprised 38% of the study population. Letters to women on state and hospital registries resulted in a 0.4% randomization rate; education sessions yielded a 10% randomization rate. The authors observed that approximately 23.6% of the study sample had no previous diagnosis of lymphedema. CONCLUSIONS: The WISER Survivor Clinical Trial faced multiple recruitment challenges and used unique strategies to successfully enroll minority survivors of breast cancer into a lifestyle intervention. Cancer 2018;124:95-104. © 2017 American Cancer Society.

The women in steady exercise research (WISER) survivor trial: The innovative transdisciplinary design of a randomized controlled trial of exercise and weight-loss interventions among breast cancer survivors with lymphedema.

INTRODUCTION: Breast cancer survivors face dual challenges: long term sequelae of treatment, and risk of recurrent disease. Obesity and a sedentary lifestyle complicate both challenges. The WISER Survivor trial assessed the effects of exercise and/or weight-loss on lymphedema, biomarkers of breast cancer recurrence, and quality of life. We report on the innovative transdisciplinary design of this trial and report attrition rates. METHODS: This one year trial randomized breast cancer survivors who had a BMI of ≥25kg/m2, were sedentary and had breast-cancer-related-lymphedema to 1) exercise (weight training and aerobic exercise) 2) weight-loss 3) exercise and weight-loss 4) or control group. Innovative aspects included: adaptation of a community-based weight training program to a largely home-based program; use of a commercial meal replacement system as part of the lifestyle modification weight-loss program; inclusion of measures of cost-effectiveness to enable economic evaluations; and alignment with a parallel mouse model for breast cancer recurrence to enable transdisciplinary research. In this model, mice bearing dormant residual tumor cells, which spontaneously relapse, were placed on a high-fat diet. Overweight animals were randomly assigned to exercise, calorie restriction, both, or control group and followed for cancer recurrence. The animal model will guide mechanistic biomarkers to be tested in the human trial. RESULTS & DISCUSSION: 351 participants were randomized; 13 experienced breast cancer recurrence during the trial. Of the 338 participants without recurrence, 83% completed the trial. The WISER Survivor trial will show the effects of exercise and weight-loss on lymphedema outcomes, biomarkers of recurrence and quality of life. NCT ClinicalTrials.gov registration #: NCT01515124.