Integration of Palliative Care for Cancer Patients on Phase I Trials

描述（由申请人提供）：1期临床试验患者通常是最“健康”的晚期癌症患者，但具有显著的症状负担。除了基线症状负担外，已知I期临床试验会增加潜在症状，恶化患者体能状态，并产生大量毒性，导致多次门诊和家人时间。在I期试验中接受治疗的患者可能会受益于跨学科的姑息治疗（PC），支持症状缓解，心理社会支持以及更好地了解其疾病目标和治疗方案的希望，同时接受疾病导向治疗。本提案的总体目的是测试同时接受姑息治疗干预（PCI）的实体瘤患者的疗效。 1期临床试验中的疾病导向治疗。具体目标包括测试PCI对患者生活质量（QOL）、心理困扰、症状强度和日常活动干扰、医院和PC资源利用、总生存率、干预结局的中介和患者对干预的满意度的疗效。这个合作项目 包括来自City of Hope和约翰霍普金斯医学研究所的Sidney Kimmel综合癌症中心的研究人员，并利用国家共识项目的质量姑息治疗临床实践指南来指导研究设计。本研究将采用随机设计，入组研究的患者将随机接受早期PC或延迟PC，并对患者进行24周随访。这是一项高度创新的RCT，其应用了根据PI当前肺癌项目（P01）改编的综合PCI。该研究将这种创新干预应用于PC的一个新领域，该领域适用于1期试验患者，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.