Building Family Caregiver Skills Using a Simulation-Based Intervention for Care of Patients with Cancer

项目概要/摘要： 头颈癌、肺癌、食道癌、直肠癌和肛门癌患者通常接受严格的、强烈的、 联合治疗（放疗、手术和/或化疗）并经历高症状负担， 功能障碍和复杂的社会心理问题。积极的治疗结果和避免 并发症在很大程度上取决于家庭成员提供的适当护理。然而，家庭 照顾者（CG）报告说，他们对承担多种复杂的照顾任务感到措手不及，包括 在气管切开护理、管饲、伤口和结肠造口术护理、疼痛管理方面提供切实的帮助， 持续的情感支持。尽管是肿瘤医疗保健团队的重要延伸， 管理症状，处理与护理对象的沟通问题，并照顾自己的身体 和情绪健康，并没有融入临床实践。这项研究将衡量一个 心理教育和技能培训干预，包括结构化模拟或体验式 学习改善CG，患者和医疗保健利用结果。模拟在训练中是有效的 医疗保健专业人员，但很少有人知道它在培训家庭CG的有效性。述干预 设计用于积极癌症治疗期间和立即过渡到治疗后生存期， 这是CG和患者最脆弱的时候。本2组前瞻性随机化研究的具体目的是 对照试验的目的是：（1）评价CG干预与对照组相比对CG的影响 主要（焦虑）和次要（抑郁、健康相关生活质量[HRQOL]和疲劳）结局;（2） 测量干预对患者结局的影响（HRQOL和中断的疗程），以及 医疗保健利用结果（计划外入院、计划外急诊室就诊和 （3）确定CG自我效能是否介导了干预对以下方面的影响： CG焦虑;（4）确定患者疾病因素、护理需求以及患者和CG人口统计学因素 调节干预和CG结果之间的关系;（5）比较医疗保健费用 干预组和对照组之间的利用率。我们将从大学医院招募180名CG 凯斯综合癌症中心的塞德曼癌症中心。干预涉及三个人， 在放射治疗期间进行一对一治疗，然后在治疗后2周进行电话联系。数据 将在基线、放射治疗结束时以及放射治疗后4周和20周收集。 分析将包括线性混合模型重复测量，中介和适度测试， Poisson回归方法拟议的项目涉及国家癌症研究所的癌症部门 控制和人口科学的使命是改善对个人和家庭成员的护理 受到癌症的影响研究结果将为翻译心理教育和 模拟方法用于其他CG人群和临床环境的干预。

Project Summary/Abstract: Patients with head and neck, lung, esophageal, rectal, and anal cancers typically undergo rigorous, intense, combined-modality treatment (radiation, surgery, and/or chemotherapy) and experience high symptom burden, functional impairment, and complex psychosocial issues. Positive treatment outcomes and avoidance of complications are dependent largely on the adequacy of care provided by family members. However, family caregivers (CGs) report feeling unprepared to assume the multiple, complex tasks of caregiving, including tangible help with tracheostomy care, tube feedings, wound and colostomy care, pain management, and ongoing emotional support. Despite being a critical extension of the oncology healthcare team, training of CGs to manage symptoms, deal with communication issues with care recipients, and take care of their own physical and emotional health, is not integrated into clinical practice. This study will measure the effect of a psychoeducational and skills training intervention that incorporates structured simulation or experiential learning to improve CG, patient, and healthcare utilization outcomes. Simulation is effective in training healthcare professionals, but little is known about its effectiveness in training family CGs. The intervention is designed for the period of active cancer treatment and the immediate transition to posttreatment survivorship, a time when the CG and patient are most vulnerable. The specific aims of this 2-group, prospective, randomized controlled trial are to: (1) evaluate the effect of a CG intervention, as compared to a control group, on CG primary (anxiety) and secondary (depression, health-related quality of life [HRQOL], and fatigue) outcomes; (2) measure the effect of the intervention on patient outcomes (HRQOL and interrupted treatment course) and healthcare utilization outcomes (unplanned hospital admission, unplanned emergency room visits, and unplanned use of intravenous fluids); (3) determine if CG self-efficacy mediates the effect of the intervention on CG anxiety; (4) determine if patient illness factors, care demands, and patient and CG demographic factors moderate the relationship between the intervention and CG outcomes; and (5) compare the costs of healthcare utilization between the intervention and control groups. We will recruit 180 CGs from University Hospitals Seidman Cancer Center at the Case Comprehensive Cancer Center. The intervention involves three in-person, one-on-one sessions during radiation treatments, followed by a telephone contact 2 weeks posttreatment. Data will be collected at baseline, at the end of radiation treatment, and 4 and 20 weeks postradiation treatment. The analysis will consist of linear mixed model repeated measures, mediation and moderation tests, and Poisson regression methods. The proposed project addresses National Cancer Institute's Division of Cancer Control and Population Sciences mission of improving the delivery of care to individuals and family members affected by cancer. The study findings will provide crucial information for translating the psychoeducational and simulation methods used in this intervention to other CG populations and clinical settings.