Women's Healthy Eating and Living Study
OBJECTIVES: I. Determine whether a diet rich in vegetables, fruit, and fiber and low in fat
is associated with a longer breast cancer event-free interval in breast cancer survivors.
II. Motivate an intervention group of breast cancer survivors to adopt and maintain a
dietary pattern that is rich in vegetables, fruit, and fiber and low in fat. III.
Demonstrate that the intervention can produce significant changes in circulating carotenoid
and estrogen biomarkers compared to a healthy control diet. IV. Test whether the probability
of a secondary cancer event is associated with change in self-reported dietary intake,
circulating carotenoid concentrations, and circulating estrogen concentrations.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age
(under 55 vs 55 and over at time of diagnosis), stage of tumor (stage I and at least 1 cm vs
stage II/IIIA), and clinical site. Patients are randomized to one of two healthy dietary
regimens: Arm I: Patients are taught to follow a dietary pattern that will produce
significant changes in circulating carotenoid and estrogen biomarkers. Arm II: Patients are
assigned to follow dietary guidelines established by the National Cancer Institute and the
USDA. All patients participate in 24 hour dietary recalls, cooking classes, as well as
complete several questionnaires, at baseline and then at 12, 24 or 36, 48, and 72 months; a
randomly selected 50% sample participate in recall at 6 months. Patients are followed by
telephone every 6 months for an average of 6 years.
PROJECTED ACCRUAL: A total of 3,000 women will be accrued for this study within 5 years.
Allocation: Randomized, Primary Purpose: Prevention
John P. Pierce, PhD
University of California, San Diego
United States: Federal Government
|Arizona Cancer Center||Tucson, Arizona 85724|
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|
|University of California San Diego Cancer Center||La Jolla, California 92093-0658|
|Permanente Medical Group (060)||Oakland, California 94611-5400|
|University of California Davis School of Medicine||Sacramento, California 95616|
|Northern California Cancer Center||Union City, California 94587|
|Center for Health Research - Portland||Portland, Oregon 97227-1110|