Symptom Management Trial in Cancer Survivors

概述和背景：该修订后的K-23申请侧重于开发癌症相关症状临床试验的专业知识。一种普遍的癌症相关症状，抑郁，可以发生在整个病程和生存期。虽然用抗抑郁药治疗是常见的，但在我们目前的科学状况中存在重大差距，而且很少有研究支持这些临床实践。该奖项将通过在肿瘤人群（现在是晚期非小细胞肺癌（NSCLC）患者）中完成一项安慰剂对照试验，作为临床试验和心理社会肿瘤学研究方法学严格培训计划的一部分，来解决其中一个空白，即抗抑郁药对重度抑郁症合并癌症疗效的证据。环境：该研究将在马萨诸塞州总医院（MGH）癌症中心进行，合并MGH精神病学部门的资源，包括抑郁症临床和研究项目（DCRP）、精神病学和医学部以及行为医学服务；dana - farber /合作伙伴CancerCare;以及哈佛公共卫生学院（HSPH）。职业发展规划：培训将强调设计、实施和分析癌症相关症状管理临床试验所需的技能。奖励期的开始将强调课程作业、咨询和进一步塑造研究项目，奖励的最后两年将用于开发R01应用程序，以继续相关研究。在HSPH密集的统计学和定量方法课程将导致MPH。在MGH，指导和研究培训将通过DCRP(博士。Fava和Nierenberg)， MGH精神病学和医学部(dr。frichione和Greenberg)， MGH癌症中心(dr。Chabner和Lynch)，以及生物统计分析和临床试验设计方面的专家(dr。Safren和Schoenfeld)。在MGH之外，培训将包括由纪念斯隆-凯特琳癌症中心（Memorial Sloan-Kettering Cancer Center）的专家提供的心理社会肿瘤学研究咨询。和丹娜-法伯癌症研究所（科恩布利斯博士）。研究计划：该研究是一项为期8周的随机、安慰剂对照试验，研究对象是抗抑郁药艾司西酞普兰，用于晚期非小细胞肺癌患者的重度抑郁症。次要目标包括评估耐受性和研究治疗反应的调节因子。

DESCRIPTION (provided by applicant): Overview and Background: This amended K-23 application focuses on developing an expertise in clinical trials for cancer-related symptoms. One prevalent cancer-related symptom, depression, can occur throughout the course of illness and into survivorship. Although treatment with antidepressants is common, major gaps exist in our current state of the science and few studies exist to support these clinical practices. This award will address one such gap, evidence for the efficacy of antidepressants for major depression comorbid with cancer, by completing a placebo-controlled trial in an oncology population, now individuals with advanced non-small cell lung cancer (NSCLC), as part of rigorous program of training in clinical trials and psychosocial oncology research methodology. Environment: The study will take place at the Massachusetts General Hospital (MGH) Cancer Center, merging the resources of the MGH Department of Psychiatry, which encompasses the Depression Clinical and Research Program (DCRP), the Division of Psychiatry and Medicine, and the Behavioral Medicine Service; Dana-Farber/Partners CancerCare; and the Harvard School of Public Health (HSPH). Career Development Plan: Training will emphasize skills necessary for designing, conducting, and analyzing clinical trials for the management of cancer-related symptoms. The beginning of the award period will emphasize coursework, consultation and further shaping of the research project, and the last two years of the award will be used to develop an R01 application to continue related research. Intensive coursework in statistics and quantitative methods at the HSPH will lead to an MPH. At MGH, mentorship and research training will obtained through the DCRP (Drs. Fava and Nierenberg), the MGH Division of Psychiatry and Medicine (Drs. Fricchione and Greenberg), the MGH Cancer Center (Drs. Chabner and Lynch), and experts in biostatistical analysis and clinical trial design (Drs. Safren and Schoenfeld). External to MGH, the training will include consultations in psychosocial oncology research from experts at Memorial Sloan-Kettering Cancer Center (Drs. Breitbart and Roth) and the Dana-Farber Cancer Institute (Dr. Kornblith). Research Plan: The study is an adequately powered eight-week randomized, placebo-controlled trial of an antidepressant, escitalopram, for major depressive disorder in people with advanced NSCLC. Secondary goals include evaluating tolerability and investigating moderators of treatment response.