Nursing's Impact on QOL Outcomes in Ovarian Cancer

描述(由申请人提供)：患有卵巢癌的女性通常在确诊时患有晚期疾病，这些女性长期存在身体问题和持续的心理痛苦的风险很高。这项研究的具体目的是：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)结果(焦虑、抑郁症状、总体QOL和不确定性)的影响，并与接受常规注意控制护理的新诊断卵巢癌成年女性进行比较；2)测试SNIP对包括卫生服务资源使用在内的护理成本的影响；3)探讨SNIP在症状苦恼类型、症状个数、生活质量维度、并发症个数、包括再住院在内的资源利用、生存时间等方面的差异。这项设计是一项单盲、随机的临床试验研究，旨在测试225名卵巢癌患者在入院后1、3和6个月行夹扎的效果。干预由一名肿瘤学高级执业护士与一名精神科咨询-联络护士进行协商，为期5个月，包括手术后护理和开始化疗。干预的效果将通过在治疗前、住院后1、3和6个月进行的自我报告问卷进行评估。与没有接受干预的患者产生的费用相比，这种干预措施将被证明是具有成本效益的。成本数据将从耶鲁-纽黑文医院的资源信息管理系统中获得，以直接衡量所需的资源。其他中介或结果变量包括：症状苦恼的模式、生活质量的维度、并发症的数量、包括再住院在内的资源利用和存活率。数据分析将包括：均值差异分析、个体差异分析和结果分析。主要分析将是具有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.