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

这个子项目是许多利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 生活方式因素似乎在乳腺癌预后中起着重要的临床作用。肥胖、低水平的体力活动和高膳食脂肪摄入都与LISA有关，LISA是一项多中心随机对照2组临床试验。这项研究的目的是评估以电话和邮件为基础的个体化干预计划，重点是体重管理，是否可以改善绝经后早期乳腺癌妇女的预后。 将评估无病生存期&40;DFS &41;、无远处转移生存期、体重等医学终点。本试验期间将检测空腹血液生物标志物和肿瘤组织。 本试验将在加拿大和美国的三个选定中心进行。主办者安大略临床肿瘤学小组41预计大约有2150名妇女参加这项研究.我们预计将有50例受试者在我们的研究中心参加研究。 受试者群体：绝经后妇女&40;BMI 24至40 kg/m2 &41;接受辅助来曲唑&40;Femara &41;用于早期乳腺癌治疗。 研究设计：对于每个受试者，将有一个2年的核心阶段干预和40;一个基于邮件的教育干预和41;和估计4-6年的DFS和其他结果的随访。在2年核心干预阶段，将在临床访视时评价体重和身高，并在随机化前和12个月访视时采集生物标志物血样。肿瘤组织可以在手术时收集用于测试。 这是一项低风险研究。抽血的效果可能会导致疼痛、出血或针头插入处的瘀伤。 为了进行这项试验，我们需要GCRC服务来测量体重和身高，并抽取血液进行生物标志物检测。 在招募访视时，我们将获得主研究以及组织和血液采集和建库子研究的个体知情同意书。

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.