Symptom Management Trial in Cancer Survivors

癌症幸存者的症状管理试验

• 批准号: 7683015
• 负责人: WILLIAM F PIRL
• 金额: $ 14.13万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-05-01 至 2011-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7683015
• 关键词: Address; Advanced Malignant Neoplasm; Adverse effects; Antidepressive Agents; Award; Behavioral Medicine; Cancer Center; Cancer Survivor; Clinical Research; Clinical Trials; Clinical Trials Design; Consultations; Dana-Farber Cancer Institute; Development Plans; Enrollment; Environment; Escitalopram; General Hospitals; Goals; Hospital Departments; Individual; Lead; Major Depressive Disorder; Malignant Neoplasms; Massachusetts; Medical; Medicine; Memorial Sloan-Kettering Cancer Center; Mentorship; Methods; Non-Small-Cell Lung Carcinoma; Patients; Placebos; Population; Psychiatry; Public Health Schools; Research; Research Methodology; Research Project Grants; Research Training; Resources; Science; Services; Shapes; Symptoms; Training; Training Programs; Upper arm; career development; clinical practice; comparative efficacy; depression; depressive symptoms; design; oncology; placebo controlled study; programs; psychologic; psychosocial; randomized placebo controlled trial; skills; social; statistics; survivorship; symptom management; treatment response

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.

概述和背景：此修订的K-23申请侧重于发展临床专业知识 癌症相关症状的试验。一个普遍的癌症相关症状，抑郁症， 在整个疾病过程中，直到生存。虽然抗抑郁药治疗很常见， 在我们目前的科学状态中存在重大差距，并且存在很少的研究来支持这些临床实践。 这个奖项将解决这样一个差距，证据的有效性抗抑郁药的抑郁症 通过在肿瘤人群中完成安慰剂对照试验，现在是个体 晚期非小细胞肺癌（NSCLC）患者，作为临床试验严格培训计划的一部分 和心理社会肿瘤学研究方法 环境：本研究将在马萨诸塞州总医院（MGH）癌症中心进行， 合并精神病学的MGH部门的资源，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;丹娜法伯/合作伙伴癌症护理;和哈佛公共卫生学院（HSPH）。 职业发展计划：培训将强调设计，执行和分析所需的技能 癌症相关症状的临床试验。奖励期开始时， 强调课程，咨询和研究项目的进一步塑造，以及过去两年的 该奖项将用于开发R01应用程序，以继续相关研究。密集课程， 统计和定量方法在HSPH将导致一个MPH。在MGH，指导和研究 培训将通过DCRP（Fava和Nierenberg博士），MGH精神病学分部和 医学（Drs. Eschione和Greenberg），MGH癌症中心（Drs. Chabner和Lynch）和专家 生物统计分析和临床试验设计（Safren和Schoenfeld博士）。在MGH之外，培训 将包括来自纪念斯隆-凯特琳的专家的心理社会肿瘤学研究咨询 癌症中心（Breitbart和Roth博士）和达纳法伯癌症研究所（Kornblith博士）。 研究计划：本研究是一项充分把握度的8周随机、安慰剂对照试验， 抗抑郁药艾司西酞普兰治疗晚期NSCLC患者的重度抑郁症。二次 目标包括评估耐受性和调查治疗反应的调节因素。