DIETARY INTERVENTION PROTOCOL -- NSABP

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The proposed study will examine the effects of a 20% fat diet on disease free survival and survival in women with stage II breast cancer who are currently entered on one of three ongoing National Surgical Adjuvant Project for Breast & Bowel Cancers (NSABP) adjuvant therapy protocols at the University of Pittsburgh. Patients who have completed at least 12 months of protocol adjuvant therapy and agree to enter this study, will be randomly assigned to a low fat diet group or a control group with no dietary intervention. The Nutrition Research Group of the Nutrition Division of the Department of Epidemiology in the Graduate School of Public Health at the University of Pittsburgh will perform at Initial Nutritional Assessment on all patients. This will include biochemical measures of nutritional parameters, anthropometric measures and a dietary assessment. A two-month period of active intervention will then be conducted on those randomized to the low fat group. This will include two home and two group sessions to provide knowledge and necessary skills to develop and maintain a low fat eating pattern. Follow-up will be conducted every four months at home or in clinic visits. Compliance will be monitored by FRR scores and measures of lipids or lipoproteins. All patients will have yearly 24-hour food recalls. Nutritional adequacy will be monitored and if necessary an active intervention to correct significant deficiencies will occur. Follow-up examinations and testing for recurrences of breast cancer or additional primary cancers, will follow the requirements of the NSABP.