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

早期乳腺癌辅助治疗的生活方式干预研究 (LISA)

• 批准号: 8174504
• 负责人: ROWAN A CHLEBOWSKI
• 金额: $ 0.83万
• 依托单位: LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-12-01 至 2010-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8174504
• 关键词: Adjuvant; Biological Markers; Blood; Blood specimen; Body Weight; Breast Cancer Treatment; Canada; Clinical; Clinical Oncology; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Dietary Fats; Disease-Free Survival; Distant; Early treatment; Educational Intervention; Fasting; Funding; Grant; Height; Institution; Intake; Intervention; Intervention Studies; Letrozole; Mails; Medical; Obesity; Oncology Group; Ontario; Operative Surgical Procedures; Outcome; Phase; Physical activity; Play; Population; Postmenopause; Randomized; Research; Research Design; Research Personnel; Resources; Role; Site; Source; Staging; Telephone; Testing; Time; Tumor Tissue; United States; United States National Institutes of Health; Visit; Weight; Woman; arm; base; follow-up; improved; intervention program; lifestyle factors; lifestyle intervention; malignant breast neoplasm

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 biomarkers 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.

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。将评估无病生存期(DFS)、远距离无病生存期、体重和其他医学终点。空腹血液生物标记物和肿瘤组织将在试验期间进行测试。 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小组)预计将有大约2150名妇女参与这项研究。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：绝经后妇女(体重指数24至40公斤/平方米)，接受来曲唑(Femara)辅助治疗早期乳腺癌。 研究设计：对于每个受试者，将有2年的核心阶段干预(基于邮件的教育干预)，以及估计额外4-6年的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。