COllaborative Care to Preserve PErformance in Cancer (COPE) Trial

描述（由申请人提供）：残疾影响约40%的癌症晚期患者，影响他们的生活质量（QoL），并从根本上增加医疗费用。数据强烈表明，积极治疗癌症相关残疾的原因;身体损伤、疼痛和相关的行动不便，可以显著延长患者的功能独立性，改善他们的生活质量，避免不必要的昂贵和延长的住院治疗。目前的康复服务提供模式本质上是被动的，往往侧重于灾难性残疾，这些特征使其不适合检测或解决癌症或任何弱势患者群体的早期残疾。一个经验验证的协作方法疼痛护理，三个组件模型（TCM），优化重要的临床结果，并可能提供一个理想的框架，以克服障碍，及时整合康复服务到癌症护理。然而，中医，鉴于其药学重点不能直接应用于康复和其需要的人的互动。因此，我们发展了一种新的中医延伸，通过聘请当地物理治疗师来解决患者的身体损伤和相关的行动不便问题，以针对残疾。初步工作表明，这一推广（中医康复服务）非常有效，深受病人和当地治疗师的欢迎。我们建议在495例晚期癌症患者中严格检查其有效性和成本，以保持癌症患者的生殖健康（科普）试验。由于疼痛与癌症相关的残疾密切相关，因此优化的疼痛控制可以最大限度地提高TCM-RS的益处。因此，除了以下两个方面外，科普还将包括：1）加强常规护理，2）通过TCM-RS针对身体损伤和行动不便的康复服务，第三个方面; 3）TCM-RS+传统中医疼痛管理TCM-RS+疼痛。参与者将接受为期4周的初始干预期，然后随访6个月，通过自动电话监测系统每月评估试验的主要结局（功能状态）和两个次要结局（疼痛和健康效用）。将在基线、3个月和6个月时评估其他结局; QoL、体力活动和护理人员负担。将从临床记录和管理数据库中提取费用。我们的目标是评估TCM-RS和TCM-RS +Pain的有效性以及成本效益和效用影响，以便为未来的研究和政策提供信息，以最大限度地减少慢性疾病人群的功能丧失。

DESCRIPTION (provided by applicant): Disablement affects about 40% of patients in the late stages of cancer, devastates their quality of life (QoL), and radically increases healthcare costs. Data strongly suggest that proactively treating the causes of cancer- related disablement; physical impairments, pain, and related immobility, can significantly prolong patients' functional independence, improve their QoL and avoid unneeded expensive and extended hospitalizations. Current rehabilitation service delivery models are reactive in nature and tend to focus on catastrophic disability, characteristics that render them ill suited to detect or address early disablement in cancer or any vulnerable patient group. An empirically validated collaborative approach to pain care, the three component model (TCM), optimizes important clinical outcomes and may provide an ideal framework to overcome barriers to the timely integration of rehabilitation services into cancer care. However, the TCM, given its pharmacotherapeutic focus cannot be directly applied to rehabilitation and its need for in-person interaction. We have, therefore, developed a novel extension of the TCM that targets disablement by engaging local physical therapists to address patients' physical impairments and related immobility. Preliminary work shows that this extension (TCM-Rehabilitation Services (TCM-RS)) is highly effective and well received by patients and local therapists. We propose to rigorously examine its effectiveness and costs among 495 patients with late stage cancer in the COllaborative Care to Preserve PErformance in Cancer (COPE) Trial. Since pain is strongly implicated in cancer-related disablement, optimized pain control may maximize the TCM-RS' benefit. COPE will therefore include, in addition to the two arms of; 1) enhanced usual care, and 2) rehabilitation services targeting physical impairments and immobility via the TCM-RS, a third arm; 3) TCM-RS plus conventional TCM pain management TCM-RS+Pain. Participants will undergo an initial 4-week intervention period and then be followed for a total of 6 months with the trial's primary outcome, functional status, and two secondary outcomes, pain and health utilities, being assessed monthly via an automated, telephonic monitoring system. Additional outcomes; QoL, physical activity, and caregiver burden, will be assessed at baseline, 3, and 6 months. Costs will be abstracted from clinical records and administrative databases. Our objective is to estimate the effectiveness, as well as the cost-benefit and -utility implications of the TCM-RS and TCM- RS+Pain in order to inform future research and policy in the means to minimize functional loss in chronically diseased populations.