Nursing's Impact on QOL Outcomes in Ovarian Cancer

描述（由申请人提供）：患有卵巢癌的妇女通常在诊断时已经患有晚期疾病，这些妇女在其疾病轨迹中长期存在身体问题和持续心理困扰的风险很高。本研究的具体目的是：1)测试标准化护理干预方案（SNIP）对新诊断为卵巢癌的成年女性在住院后1、3和6个月的生活质量（QOL）结局（焦虑、抑郁症状、总体生活质量和不确定性）的影响，并与接受常规注意控制护理的新诊断为卵巢癌的成年女性进行比较；2)测试SNIP对医疗成本的影响，包括卫生服务资源的使用；3)探讨SNIP对症状窘迫模式、症状数量、生活质量维度、并发症数量、资源利用（包括再住院）和生存的差异影响。该设计是一项单盲、随机临床试验研究，旨在测试SNIP对225名卵巢癌患者在住院后1、3和6个月的影响。干预由一名肿瘤学高级执业护士与一名精神病学咨询联络护士共同提供，为期5个月，包括术后护理和化疗的开始。干预的效果将在治疗前、住院后1、3和6个月使用自我报告问卷进行评估。与不接受干预的患者所产生的费用相比，干预将被证明具有成本效益。成本数据将从耶鲁-纽黑文医院的资源信息管理系统获得，以直接衡量所需的资源。其他中介或结果变量包括：症状窘迫的模式、生活质量的维度、并发症的数量、资源利用（包括再住院）和生存率。数据分析包括：平均差异分析、个体差异分析和结果分析。主要分析将是重复测量的多变量协方差分析。

DESCRIPTION (provided by applicant): Women who develop ovarian cancer usually present with advanced disease at diagnosis and these women are at high risk for prolonged physical problems and sustained psychological distress over their illness trajectory. The specific aims of the study are to: 1) test the effects of a standardized nursing intervention protocol (SNIP) on quality of life (QOL) outcomes (anxiety, depressive symptoms, overall QOL, and uncertainty) for adult women newly diagnosed with ovarian cancer at 1, 3, and 6 months post-hospitalization as compared to adult women newly diagnosed with ovarian cancer who receive usual attention control care plus; 2) test the effects of SNIP on costs of care, including health services resource use; and 3) explore the differential effects of SNIP on patterns of symptom distress, number of symptoms, dimensions of QOL, number of complications, resource utilization including rehospitalizations, and survival. The design is a single blind, randomized clinical trial study to test the effects of a SNIP in 225 patients with ovarian cancer at 1,3, and 6 months post-hospitalization. The intervention is provided by an oncology advanced practice nurse working in consultation with a psychiatric consultation-liaison nurse over a 5-month period including post-surgical care and the initiation of chemotherapy. The effects of the intervention will be evaluated using self-report questionnaires administered at pre-treatment, 1, 3, and 6 months post-hospitalization. The intervention will be demonstrated to be cost effective when compared to costs incurred by patients who do not receive it. Cost data will be obtained from the Resource Information Management System at Yale-New Haven Hospital to measure directly required resources. Additional mediating or outcome variables include: patterns of symptom distress, dimensions of QOL, number of complications, resource utilization including rehospitalizations, and survival. Data analysis will include: mean difference analyses, individual difference analyses, and outcome analyses. The primary analysis will be a multivariate analysis of covariance with repeated measures.