Symptom Management Trial in Cancer Survivors

概述和背景：这份修改后的K-23申请侧重于培养临床专业知识 癌症相关症状的试验。一种与癌症相关的普遍症状--抑郁--可能会出现 在疾病的整个过程中一直存活下来。尽管使用抗抑郁药物治疗很常见， 我们目前的科学状况存在重大差距，支持这些临床实践的研究很少。 这一奖项将解决一个这样的空白，即抗抑郁药物对重度抑郁症有效的证据。 与癌症并存，在肿瘤学人群中完成了一项安慰剂对照试验，现在是个人 晚期非小细胞肺癌(NSCLC)，作为临床试验严格培训计划的一部分 和心理社会肿瘤学的研究方法。 环境：这项研究将在马萨诸塞州总医院(MGH)癌症中心进行， 合并包括抑郁症临床在内的MGH精神病科的资源 和研究计划(DCRP)，精神病学和医学部，以及行为医学 Dana-Farber/Partners CancerCare和哈佛大学公共卫生学院(HSPH)。 职业发展计划：培训将强调设计、执行和分析所需的技能 治疗癌症相关症状的临床试验。授权期开始时， 强调课程工作、咨询和进一步形成研究项目，以及最近两年 该奖项将用于开发R01应用程序，以继续相关研究。密集的课程作业 HSPH的统计和定量方法将导致公共卫生小时数。在麻省理工学院，指导和研究 培训将通过DCRP(Fava和Nierenberg博士)、MGH精神病学和 医学(Fricchione和Greenberg博士)、MGH癌症中心(Chabner和Lynch博士)和专家 生物统计分析和临床试验设计(萨夫伦和舍恩菲尔德博士)。在MGH之外，培训 将包括斯隆-凯特林纪念医院专家在心理社会肿瘤学研究方面的咨询 癌症中心(Breitbart和Roth博士)和Dana-Farber癌症研究所(Kornblith博士)。 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， 抗抑郁药艾司匹兰，用于晚期非小细胞肺癌患者的主要抑郁障碍。次要的 目标包括评估耐受性和调查治疗反应的调节因素。

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.