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诊断时表现为晚期疾病，这些女性在其疾病轨迹上存在长期身体问题和持续心理困扰的高风险。本研究的具体目的是：1）测试标准化护理干预方案（SNIP）对生活质量（QOL）结果的影响（焦虑，抑郁症状，总体生活质量和不确定性）的成年女性新诊断为卵巢癌在住院后1，3，和6个月相比，成年女性新诊断为卵巢癌谁接受常规的注意力控制护理加; 2）测试SNIP对护理成本的影响，包括卫生服务资源的使用; 3）探索SNIP对症状困扰模式、症状数量、QOL维度、并发症数量、资源利用（包括再住院）和生存率的不同影响。该设计是一项单盲、随机临床试验研究，旨在测试SNIP在225例卵巢癌患者住院后1、3和6个月的效果。干预由一名肿瘤学高级实践护士提供，与一名精神科咨询联络护士协商，为期5个月，包括手术后护理和化疗的开始。将使用治疗前、住院后1、3和6个月的自我报告问卷评价干预的效果。将从耶鲁-纽黑文医院的资源信息管理系统中获得成本数据，以直接衡量所需的资源。其他中介或结果变量包括：症状困扰模式、QOL维度、并发症数量、资源利用（包括再住院）和生存率。数据分析将包括：平均差异分析、个体差异分析和结局分析。主要分析将是重复测量的协方差多变量分析。

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.