LIFESTYLE INTERVENTION STUDY IN ADJUVANT TREATMENT OF EARLY BREAST CANCER (LISA)

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 生活方式因素似乎在乳腺癌预后中扮演着重要的临床角色。肥胖、低体力活动水平和高膳食脂肪摄入量都表明LISA是一项多中心、随机对照的双臂临床试验。这项研究的目的是评估以体重管理为重点的电话和邮件个性化干预计划是否可以改善患有早期乳腺癌的绝经后妇女的预后。无病生存期、远距离无病生存期、体重和其他医学终点将被评估。在这项试验中，将对空腹血液、生物标志物和肿瘤组织进行测试。 这项试验将在加拿大和美国选定的三个中心进行。赞助商安大略省临床肿瘤学集团预计将有大约2150名女性参与这项研究。我们预计将有50名受试者参加我们研究网站上的这项研究。 研究对象：40名绝经后妇女；体重指数24至40公斤/平方米；接受来曲唑40；女性早期乳腺癌治疗的辅助剂。 研究设计：对于每个受试者，将有两年的核心阶段干预；一项基于邮件的教育干预；以及估计4-6年对DFS和其他结果的随访。在为期2年的核心干预阶段，将在临床访问时评估体重和身高，并在随机前和12个月访问时采集血液样本以检测生物标志物。可以在手术时采集肿瘤组织进行检测。 这是一项低风险的研究。抽血的效果可能会导致针头插入部位疼痛、出血或瘀伤。 为了进行这项试验，我们需要GCRC服务来测量体重和身高，并抽取血液作为生物标志物。 在招募访问中，我们将就主要研究和组织、血液采集和银行分项研究获得个人知情同意。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Lifestyle factors appear to play a clinically important role in breast cancer outcome. Obesity, low levels of physical activity and high dietary fat intake have all been implicated LISA is a multicenter randomized controlled 2 arm clinical trial. The objective of the study is to evaluate if a telephone and mail-based individualized intervention program focusing on weight management can improve outcomes in postmenopausal women with early stage breast cancer. The disease-free survival (DFS), distant disease-free survival, body weight and other medical endpoints will be evaluated. Fasting blood biomakers and tumor tissue will be tested during this trial. This trial will be conducted in Canada and three selected centers in the United States. The sponsor (Ontario Clinical Oncology Group) expect that approximately 2150 women will take part in this study. We expect 50 subjects will take part in the study in our study site. Subject population: postmenopausal women (BMI 24 to 40 kg/m2) receiving adjuvant Letrozole (Femara) for early stage breast cancer treatment. Study design: for each subject, there will be a 2 years core phase intervention ( a mail-based educational intervention ) and an estimated 4-6 additional years follow-up for DFS and other outcomes. During the 2 years core intervention phase, body weight and height will be evaluated at their clinical visit and blood sample for biomarker will be collected at pre-randomization and 12 month visits. Tumor tissue may be collected for testing at the time of surgery. This is a low risk study. The effect of drawing blood may cause pain, bleeding or bruise where the needle is inserted. To conducting this trial we need GCRC service for measuring body weight and height, and drawing blood for biomarkers. At recruitment visit, we will be obtaining individual informed consent for both the main study and the tissue and blood collection and banking sub-study.