Family Home Care for Cancer-Community Based Model

描述(由申请人提供)：这份修订后的竞争续签申请旨在确定在接受化疗疗程并报告在过去7天内既有疼痛又有疲劳的家庭照料者和晚期(III或IV期)疾病患者中，与具有相同纳入标准但暴露于注意力控制干预的家庭照顾者和患者相比，为期8周、6次接触的问题解决、自我护理管理干预对症状数量、身体角色影响、社会功能和情绪困扰的影响。患者症状和支持管理干预(PIMSS)帮助患者和他们的照顾者解决和管理三个问题领域：症状、功能(身体角色影响和社会功能)和情绪困扰。每个领域的问题通过4个干预主题来解决：自我照顾行为、与家人和提供者的沟通、信息教学以及咨询和支持。循证干预策略和NCCN指南是从计算机辅助文档中选择的，它允许护士个体化实施策略，并增强患者的自我效能，以便在干预后保留策略。患者被指示与其家庭照顾者沟通，以协助他们在家中实施干预措施并对援助请求作出回应。试验的两个分支的患者和照顾者都得到了相同数量的面对面和电话联系。这两组人都收到了工具包。注意力控制干预和工具包不提供与症状、功能或痛苦相关的内容。因此，实验臂中提供的内容的效果可以单独与注意力分开。这项研究将从三个癌症入院患者中收集350名患者，磨损率为30%，以保留最终分析所需的244例患者(每臂122例)。计算能量的主要结果是9周时的症状数量。这项研究谨慎地建立在现有RCT证据的基础上，该证据支持化疗、分期以及疼痛和疲劳的存在对不良结果风险的影响。如果更短、更强烈的干预可以改善高危患者的结果，这就提供了基于理论的证据，证明行为干预对改善对患者和家庭重要的结果具有“增值”作用。这将使此类干预措施成为临床实践中令人信服的补充。

DESCRIPTION (provided by applicant): This revised competitive renewal application seeks to determine among family caregivers and patients with advanced (stages III or IV) disease who are undergoing a course of chemotherapy and who report both pain and fatigue during the past 7 days, the effect of an 8-week, 6-contact problem-solving, self care management intervention upon the number of symptoms, physical role impact, social function and emotional distress when compared with family caregivers and patients with identical inclusion criteria but who are exposed to an attention control intervention. The Patient Intervention for Management of Symptoms and Support (PIMSS) assists patients and their caregivers to address and manage three problem domains; symptoms, function (physical role impact and social function), and emotional distress. Problems in each domain are addressed through 4 intervention themes; self-care behaviors, communication with family and providers, information-teaching, and counseling and support. Evidenced-based intervention strategies and NCCN guidelines are selected from computer assisted documentation that allows nurses to individualize strategies for implementation and to enhance patient self-efficacy so that strategies are retained following the intervention. Patients are directed to communicate with their family caregivers to assist them to implement interventions at home and to respond to requests for assistance. Patients and caregivers in both arms of the trial receive the same number of in-person and telephone contacts. Both groups receive toolkits. The attention control intervention and toolkit provides no content related to symptoms, function or distress. Thus the effect of content provided in the experimental arm may be separated from attention alone. This research will accrue 350 patients from three cancer enters with an attrition rate of 30% to retain the needed 244 cases (122 per arm) for the final analyses. The primary outcome on which power is calculated is the number of symptoms at 9 weeks. This research builds carefully upon evidence from a current RCT which supports the impact of chemotherapy, stage, and presence of pain and fatigue upon the risk of poor outcomes. If a shorter, more intense intervention can improve the outcomes of patients at high risk, this provides theoretically based evidence of the "value added" contribution of behavioral interventions towards improving outcomes important to patients and families. That would make such interventions compelling additions to clinical practice.