COllaborative Care to Preserve PErformance in Cancer (COPE) Trial

保持癌症表现的协作护理 (COPE) 试验

基本信息

批准号：
8434848
负责人：
Andrea Lynne Cheville
金额：
$ 57.21万
依托单位：
MAYO CLINIC ROCHESTER
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-03-01 至 2017-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8434848
关键词：
Address Affect Cancer Etiology Cancer Patient Caregiver Burden Caregivers Caring Characteristics Clinical Communities Costs and Benefits Data Dependency Diagnostic Neoplasm Staging Effectiveness Future Goals Guidelines Health Health Care Costs Hospitalization Impairment Instruction Intervention Knowledge Malignant Neoplasms Mediating Medical Modeling Monitor Nature Nurses Outcome Pain Pain management Participant Patients Performance Persons Physical activity Physical therapy Policies Population Progressive Disease Quality of life Randomized Records Recurrence Rehabilitation therapy Relative (related person)Specialist Staging Supportive care System Target Populations Work abstracting administrative database arm base cancer care care delivery collaborative care comparative comparative effectiveness conditioning cost cost effective cost effectiveness disability effectiveness trial evidence base functional loss functional status health care service utilization improved insight novel physical conditioning prevent primary outcome programs rehabilitation service secondary outcome treatment as usual

项目摘要

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.

描述（由申请人提供）：大约 40% 的癌症晚期患者会出现残疾，严重影响他们的生活质量 (QoL)，并大幅增加医疗费用。数据强烈表明，积极治疗癌症相关残疾的原因；身体损伤、疼痛和相关的不活动，可以显着延长患者的功能独立性，提高他们的生活质量，并避免不必要的昂贵和长期住院治疗。目前的康复服务提供模式本质上是反应性的，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。三成分模型（TCM）是一种经过经验验证的疼痛护理协作方法，可优化重要的临床结果，并可能提供一个理想的框架来克服将康复服务及时整合到癌症护理中的障碍。然而，鉴于中医的药物治疗重点，不能直接应用于康复及其对面对面互动的需求。因此，我们开发了一种新颖的中医延伸方案，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，从而针对残疾问题。初步工作表明，这一延伸服务（TCM-RS）非常有效，受到患者和当地治疗师的好评。我们建议在“协作护理以保持癌症表现”(COPE) 试验中，在 495 名晚期癌症患者中严格检查其有效性和成本。由于疼痛与癌症相关的残疾密切相关，优化的疼痛控制可以最大限度地发挥 TCM-RS 的益处。因此，除了以下两个方面之外，COPE 还将包括： 1) 加强常规护理，2) 通过第三臂 TCM-RS 针对身体损伤和行动不便的康复服务； 3) TCM-RS加传统中医疼痛治疗TCM-RS+Pain。参与者将接受为期 4 周的初始干预期，然后进行为期 6 个月的随访，其中试验的主要结果（功能状态）和两个次要结果（疼痛和健康效用）每月通过自动电话监控系统进行评估。额外的成果；将在基线、3 个月和 6 个月时评估生活质量、体力活动和护理人员负担。费用将从临床记录和管理数据库中提取。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，以尽量减少慢性病人群的功能丧失。