LOW FAT DIET-WOMEN AT INCREASED RISK FOR BREAST CANCER

这项建议建议在国家预防中心设立和运作一个临床单位 低脂饮食疗效的多中心随机临床试验 脂肪(卡路里的20%)在预防乳腺癌中的作用 增加患乳腺癌的风险。该试验的主要目标是 确定低脂饮食是否可以降低乳腺癌的发病率。 这项申请建议该单位参与所有三个阶段的 合作协议审判机制的发展 两个月的议定书，十个月的可行性试验，以及 为期48个月的全面试验。贝勒临床单位将由以下人员组成 贝勒血脂研究诊所分包合作 与圣约瑟夫医院乳腺癌检测中心合作。对于 在可行性和全面试验方面，该股将研究200-240人的队列 从乳腺癌检测中心招募的患者根据 协议标准。该单位将与试验的其他单位合作 临床单位、营养协调单位、统计协调单位、 和国家情报局。贝勒单位的主要目标包括：1)运营 利用微型计算机辅助的经济、准确的临床单元 监测和管理诊所的运作和质量控制 数据。2)为了在这个功效试验中获得最大的饮食依从性，使用 标准技术和创新技术的结合，包括选择 通过依从性筛查具有高依从性的受试者 考试和淘汰标准，由训练有素的个人咨询 开发了经过咨询技术培训的营养师/依从性顾问 由贝勒血脂研究诊所协助的即时分析 微机化营养分析记录患者7天的饮食记录 通过食品模型、烹饪演示、 幻灯片磁带、时事通讯和公告栏。坚持心理咨询是 基于依从性的识别、诊断和管理 使用行为技术和频繁咨询患者的问题 联系。3)评价饮食记录、24小时饮食回忆、 1-7天饮食自我记录，以及饮食依从性的客观措施 体重、皮肤皱纹厚度、血浆总胆固醇和高密度脂蛋白 胆固醇，以及亚油酸在血浆胆固醇中的比例 酯类化合物。临床试运行的最佳方法--坚持 管理和监督，从可行性试验开始，将应用于 全面的试验。该项目的意义是潜在的 制定预防高危妇女癌症的饮食方法 乳腺癌的风险。

This proposes to establish and operate a Clinical Unit in the NCI's Multicenter randominized clinical trial of the efficacy of a diet low in fat (20% of calories) in the prevention of breast cancer in women with increased risk for breast cancer. The trial's primary objective is to determine if the low-fat diet can decrease the incidence of breast cancer. This application proposes the unit's participation in all three phases of the Trial by the cooperative agreement mechanism: development of the protocol in two months, the feasibility trial of ten months, and the full-scale trial of 48 months. The Baylor Clinical Unit will consist of the Baylor Lipid Research Clinic working in collaboration by subcontract with the Breast Cancer Detection Center of St. Joseph's Hospital. For the feasibility and full scale trials, the Unit will study a cohort of 200-240 patients recruited from the Breast Cancer Detection Center according to the protocols criteria. The unit will collaborate with the Trial's other Clinical Units, Nutrition Coordinating Unit, Statistical Coordinating Unit, and the NCI. The Baylor Unit's major aims include: 1) To operate the Clinic Unit with economy and accuracy using a micro-computer assisted surveillance and management of clinic operations and quality control of data. 2) To gain maximum dietary adherence for this efficacy trial using a combination of standard and innovative techniques, including selection of subjects with high potential for adherence by an adherence screening examination and washout criteria, individual counseling by trained Dietitian/Adherence Counselors trained in counseling techniques developed by the Baylor Lipid Research Clinic aided by immediate analysis of the patient's 7-day food record by the micro-computer based Nutrient Analysis System and multimedia instruction by food models, cooking demonstrations, slide tapes, newsletters, and bulletin boards. Adherence counseling is based upon the identification, diagnosis of and management of adherence problems using behavioral techniques and frequent counselor-patient contact. 3) To evaluate methods of diet recording, 24-hour diet recall, 1-7 day diet self-recording, and objective measures of diet adherence as body weight, skin fold thickness, plasma total cholesterol, and HDL cholesterol, and the proportion of linoleic acid in the plasma cholesteryl esters. The optimum methods of clinical trial operation, adherence management and surveillance, from the feasibility trial will be applied to the full-scale trial. The project's significance is a potential for developing a dietary method for prevention of cancer in women at high-risk of breast cancer.