Symptom Management Trial in Cancer Survivors

描述(由申请人提供)：概述和背景：这份修改后的K-23申请侧重于发展癌症相关症状临床试验的专业知识。一种与癌症相关的普遍症状--抑郁，可能会在整个病程中出现并存活下来。虽然使用抗抑郁药物治疗很常见，但在我们目前的科学状态中存在着重大差距，几乎没有研究支持这些临床实践。该奖项将通过完成在肿瘤学人群(现在患有晚期非小细胞肺癌(NSCLC)的个人)中进行的安慰剂对照试验，作为临床试验和心理社会肿瘤学研究方法严格培训计划的一部分，来解决这样一个空白，即抗抑郁药物对与癌症共存的严重抑郁症的有效性的证据。环境：这项研究将在马萨诸塞州总医院(MGH)癌症中心进行，合并MGH精神病学系的资源，其中包括抑郁症临床和研究计划(DCRP)、精神病学和医学部以及行为医学服务；Dana-Farber/Partners癌症护理；以及哈佛大学公共卫生学院(HSPH)。职业发展计划：培训将强调设计、实施和分析管理癌症相关症状的临床试验所需的技能。获奖期的开始将强调课程工作、咨询和研究项目的进一步形成，获奖的最后两年将用于开发R01应用程序，以继续相关研究。HSPH在统计学和定量方法方面的密集课程将导致公共卫生小时。在MGH，指导和研究培训将通过DCRP(Fava和Nierenberg博士)、MGH精神病学和医学部(Fricchione和Greenberg博士)、MGH癌症中心(Chabner和Lynch博士)以及生物统计分析和临床试验设计专家(Safren和Schoenfeld博士)进行。在麻省理工学院之外，培训将包括来自纪念斯隆-凯特琳癌症中心(布莱巴特和罗斯博士)和达纳-法伯癌症研究所(康布利斯博士)的专家在心理社会肿瘤学研究方面的咨询。研究计划：这项研究是一项为期八周的随机、安慰剂对照试验，用于治疗晚期非小细胞肺癌患者的主要抑郁障碍。次要目标包括评估耐受性和调查治疗反应的调节因素。

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.