LOW FAT DIET AND BREAST CANCER RECURRENCE--OUTCOME TRIAL

妇女干预营养研究（WINS）是一项正在进行的随机多中心临床试验，该试验的假设是，减少饮食脂肪摄入量作为标准乳腺癌治疗的辅助手段，将减少疾病复发，提高局限性乳腺癌妇女的生存率。这一假设是基于临床前研究、流行病学观察和合理的介导作用机制。目前，2096名女性（目标是达到2500名最终应计目标）在诊断后的一年内被随机分配到减少脂肪摄入干预组或对照组。饮食干预以社会认知理论为基础，包括接受过动机性访谈培训的营养学家的个性化咨询，包括目标评估、量身定制的信息、自我监控和认知重组。通过连续、不事先通知的电话召回评估，饮食依从性维持了三年，干预参与者的饮食脂肪摄入量显著（P<0.0008）减少。因此，WINS已被证明有能力积累所需的乳腺癌患者人数，并在干预组中保持足够的饮食依从性，以充分解决研究假设。患者继续随访无病生存期（作为主要研究终点）和总生存期。制定的长期坚持策略包含一个激励行动计划（MAP），其中包括个性化的需求评估和加强会议。集中式保留协议（包括与参与者的“伙伴关系”）和通讯完全可操作。研究组织包括一个行政单位、一个外部咨询委员会、一个营养协调单位、一个临床主任办公室、一个统计协调单位、两个区域营养中心和超过34个临床站点，并结合了既定的质量保证程序。这项研究的完成将为膳食脂肪摄入对乳腺癌患者预后的影响提供明确的评估。本建议要求支持继续积极饮食干预临床随访和终点确定，以充分评估所有研究假设。

The Women's Intervention Nutrition Study (WINS) is an ongoing randomized multicenter clinical trial testing the hypothesis that dietary fat intake reduction as an adjuvant to standard breast cancer therapy will reduce disease recurrence and increase survival for women with localized breast cancer. The hypothesis is based on preclinical studies, epidemiological observations and plausible mediating mechanisms of action. Currently, 2096 women (on target to meet the 2,500 final accrual objective) have been randomized within one year of diagnosis to a fat intake reduction Intervention or a Control group. The dietary intervention, based on social cognitive theory, involves individualized counseling by nutritionists trained in motivational interviewing and includes goal assessment, tailored messages, self-monitoring and cognitive restructuring. Dietary adherence, assessed with serial, unannounced telephone recalls has been maintained through three years with demonstrated significant (P<0.0008) reduction in dietary fat intake in intervention participants. Thus, WINS has a demonstrated capability to both accrue the required population of breast cancer patients and maintain sufficient dietary adherence in the Intervention group to fully address the study hypotheses. Patients continue to be followed for disease-free survival (as primary study endpoint) and overall survival. Developed long-term adherence strategies contain a Motivational Action Plan (MAP) that includes an individualized assessment of needs with booster sessions. Centralized retention protocols including "partnering" with participants, and newsletters are fully operational. Study organization includes an Administrative Unit, an External Advisory Committee, a Nutrition Coordinating Unit, a Clinical Director's Office, a Statistical Coordinating Unit, two Regional Nutrition Centers and over thirty-four Clinical Sites, and incorporates established quality assurance 'procedures. Completion of this study will provide definitive evaluation of the effect of dietary fat intake on breast cancer patient outcome. This proposal requests support needed to continue the active dietary intervention clinical follow-up and endpoint determinations needed to fully assess all study hypotheses.