Integration of Palliative Care for Cancer Patients on Phase I Trials

描述(申请人提供)：第一阶段临床试验患者通常是最“健康”的晚期癌症患者，但有显著的症状负担。除了基线症状负担外，已知1期临床试验还会增加潜在症状，恶化患者表现状况，并产生大量毒性，导致多次就诊和家人的时间。在第一阶段试验中接受治疗的患者可能受益于跨学科姑息治疗(PC)，这种治疗支持症状缓解、心理社会支持的希望，并在同时接受疾病导向治疗的同时更好地了解他们的疾病目标和治疗方案。这项建议的总体目的是测试并行姑息护理干预(PCI)对接受实体肿瘤治疗的患者的疗效。 第一阶段临床试验中的疾病导向治疗。具体目的包括测试经皮冠状动脉介入治疗对患者生活质量(QOL)、心理困扰、症状强度和对日常活动的干扰、医院和个人电脑资源利用、总体生存、干预结果的中介以及患者对干预的满意度的有效性。此协作项目 来自希望之城和约翰霍普金斯医学院西德尼·基梅尔综合癌症中心的研究人员参与了这项研究，并利用国家共识项目的优质姑息治疗临床实践指南来指导研究设计。这项研究将采用随机设计，将登记参加研究的患者随机分为早期PC组或延迟PC组，并对患者进行24周的随访。这是一种高度创新的随机对照试验，它应用了一种综合的经皮冠状动脉介入治疗，改编自PI的当前计划项目(P01)，用于肺癌。这项研究将这种创新的干预措施应用于PC的一个新领域，适用于第一阶段试验患者，这是最脆弱的患者群体之一。

DESCRIPTION (provided by applicant): Phase 1 clinical trial patients are generally among the most "well" of advanced disease cancer patients but have a significant symptom burden. In addition to a baseline symptom burden, Phase 1 clinical trials are known to increase potential symptoms, worsen patient performance status, and confer substantial toxicities that result in multiple clinic visits and time from family. Patients treated on Phase 1 trials may benefit from interdisciplinary palliative care (PC) that supports hopes for symptom relief, psychosocial support, and better understanding of their illness goals and treatment options while concurrently receiving disease-directed therapies. The overall purpose of this proposal is to test the efficacy of a concurrent palliative care intervention (PCI) for patients with solid tumors who are receiving disease-directed treatments in Phase 1 clinical trials. Specific aims include testing the efficacy of the PCI on patients' quality of life (QOL), psychological distress, symptom intensity and interference with daily activities, hospital and PC resource utilization, overall survival, mediatos of intervention outcome, and patient satisfaction with the intervention. This collaborative project involves investigators from the City of Hope and the Sidney Kimmel Comprehensive Cancer Center of the Johns Hopkins Medical Institutes, and utilizes the National Consensus Project's Clinical Practice Guidelines for Quality Palliative Care to guide study design. The study will utilize a randomized design, where patients enrolled in the study will be randomized to either receiving early PC or delayed PC, and patients will be followed for 24 weeks. This is a highly innovative RCT which applies a comprehensive PCI adapted from the PI's current Program Project (P01) in lung cancer. The study applies this innovative intervention to a novel area of PC applied to Phase 1 trial patients, one of the most vulnerable patient groups.