Cancer Prevention Program

Women’s Health Initiative Clinical Coordinating Center Extension, 2011-2015

PI: Garnet Anderson, PhD
Co-Investigators: Charles Kooperberg, PhD, Andrea Z. LaCroix, PhD, Ross L. Prentice, PhD

Fred Hutchinson's Public Health Sciences Division houses the Clinical Coordinating Center for the Women's Health Initiative, or WHI, one of the largest National Institutes of Health-funded studies ever conducted in women. This 15-year, multimillion-dollar study, established in 1991, involves more than 160,000 women nationwide, including some 3,500 in Washington.

The Clinical Coordinating Center coordinates the statistical, epidemiologic, nutritional and clinical aspects of the WHI and is responsible for data collection, management and analysis. The Clinical Coordinating Center also plays a key role in clinical, nutritional, laboratory and data quality-assurance activities. Half of the Clinical Coordinating Center resides in the division's Program in Biostatistics, while half resides in the division's Cancer Prevention Research Program.

The WHI had two components: a clinical trial and an observational study. The clinical-trial component, which involved 67,000 postmenopausal women ages 50-79, rigorously compared the benefits and risks of interventions that might help prevent the diseases responsible for most of the mortality and morbidity in older women: cardiovascular disease, breast and colorectal cancers, and fractures. These interventions are hormone-replacement therapy, both estrogen alone and combined estrogen and progestin (to prevent cardiovascular disease/fractures); a low-fat diet (to prevent breast and colorectal cancers); and calcium and vitamin D supplementation (to prevent fractures). The observational-study component of the WHI, which involves 93,000 postmenopausal women ages 50-79, is designed to identify predictors of disease and to minimize disease occurrence. After the conclusion of the clinical trials, all women who agreed to continue in follow-up have been followed for health outcomes in the two extensions of the WHI.

The current WHI extension is conducted through 11 clinical sites nationwide, including a study clinic in Seattle that is run by Fred Hutchinson. Each month, about 9,000 are contacted by phone or mail. These contacts monitor the health outcomes of the study participants.

For more information about the Women's Health Initiative, see: www.whi.org