Web-Based Ovarian Cancer Symptom Control: Nurse-Guided vs. Self-Directed

描述（由申请人提供）：2008年将有超过22,000名妇女被诊断患有卵巢癌。大多数会在晚期被诊断出来，并且会在治疗后2年内复发。积极的化疗和疾病进展引起广泛的症状，可显著损害生活质量（QOL）。一种创新的干预措施，写症状(c)[缓解症状的书面代表性干预]，建立在以前的症状管理方法的基础上，通过强调在提供新信息之前了解患者对其最重要症状群的表现。目前，WRITE症状(c)由护士通过互联网留言板发布。目前一项针对复发性卵巢癌妇女的试点研究表明，WRITE症状(c)是一种可行的、可接受的干预措施，初步分析为干预措施的有效性提供了早期支持。一个关键问题是，护士的个性化是否对WRITE症状(c)干预的成功至关重要，或者妇女是否可以在没有护士帮助的情况下，通过基于网络的交互式计算机模块指导完成该计划（称为“自我指导WRITE症状(c)”）。自主模块开发完成，初步评估支持其可行性；可接受性;内容、功能和理论有效性。本研究的主要目的是比较护士指导的WRITE症状(c)与自我指导的WRITE症状(c)与常规护理在改善复发性卵巢癌妇女目标症状的表现（严重程度、后果、痛苦和可控性）方面的疗效。次要目的是：1)比较每种干预措施在改善生活质量、与卫生保健提供者沟通和使用症状管理策略方面的相对疗效；2)探讨潜在的长期影响；3)评估症状表征的改变是否介导生活质量的改变；4)评价干预效果的调节因子。为了实现研究目标，将从全国各地的妇科肿瘤集团诊所招募480名患有3种或3种以上疾病或治疗相关症状的复发性卵巢癌妇女。受试者将完成人口统计学和临床信息、症状表征和生活质量的基线测量。基线评估后，妇女将被随机分配到三种干预措施中的一种：护士指导的WRITE症状(c)、自我指导的WRITE症状(c)或照旧护理。两个WRITE症状组的受试者在研究的前7周参与干预。结果指标每月评估一次。本研究评估了一种创新的症状评估和管理方法。需要获得的关于心理教育干预的关键组成部分的知识和通过它们影响结果变化的机制可以改善患者群体的症状管理。干预措施;公共卫生相关性：每年有22 000多名妇女被诊断患有卵巢癌，14 000多名妇女死于该疾病。在2000年疾控中心主办的题为“确定减轻卵巢癌负担的公共卫生机会”的研讨会上，确定了改善卵巢癌患者生活质量的研究作为优先事项。从拟议的研究中获得的信息测试了两种基于网络的卵巢癌症状管理方法的有效性，应该促进对减少癌症相关发病率和改善生活质量所需干预措施的关键要素的理解。

DESCRIPTION (provided by applicant): Over 22,000 women will be diagnosed with ovarian cancer in 2008. Most will be diagnosed in advanced stages, and will experience a recurrence within 2 years after treatment. Aggressive chemotherapy and disease progression cause a wide range of symptoms that can significantly impair quality of life (QOL). An innovative intervention, WRITE Symptoms(c) [Written Representational Intervention To Ease Symptoms], builds on previous approaches to symptom management through an emphasis on understanding a patient's representation of her most significant symptom cluster prior to providing new information. Currently, WRITE Symptoms(c) is delivered by nurses via Internet message boards. A current pilot study of women with recurrent ovarian cancer has shown that WRITE Symptoms(c) is a feasible, acceptable intervention, and preliminary analyses provide early support for efficacy of the intervention. A key question is whether individualization by nurses is critical to the success of the WRITE Symptoms(c) Intervention, or whether women can be guided through the program by a web-based, interactive computer module without assistance from a nurse (referred to as "Self-directed WRITE Symptoms(c)"). Development of the self- directed module is complete and preliminary evaluations support its feasibility; acceptability; and content, functional, and theoretical validity. The primary aim of the proposed study is to compare the efficacy of nurse-guided WRITE Symptoms(c) vs. self-directed WRITE Symptoms(c) vs. care as usual in improving representations (severity, consequences, distress, and controllability) of target symptoms for women with recurrent ovarian cancer. Secondary aims are to 1) compare the relative efficacy of each intervention for improving QOL, communication with health care providers, and use of symptom management strategies; 2) explore potential long-term effects of the 3) evaluate whether changes in symptom representations mediate changes in QOL; and 4) evaluate moderators of intervention effect. To address study aims, 480 women with recurrent ovarian cancer who are experiencing 3 or more disease- or treatment-related symptoms will be recruited from Gynecologic Oncology Group clinics across the country. Subjects will complete baseline measures of demographic and clinical information, symptom representations, and QOL. Following baseline assessment, women will be randomly assigned to one of three interventions: nurse-guided WRITE Symptoms(c), self- directed WRITE Symptoms(c), or Care-as-usual. Subjects in the two WRITE Symptoms arms engage in the interventions over the first 7 weeks of the study. Outcome measures are assessed monthly. This study evaluates an innovative approach to symptom assessment and management. The knowledge to be gained about critical components of psycho-educational interventions and mechanisms through which they effect changes in outcomes could improve symptom management across patient populations. interventions; PUBLIC HEALTH RELEVANCE: Each year over 22,000 women are diagnosed with ovarian cancer and over 14,000 die of the disease. Research to improve the quality of life for ovarian cancer patients was identified as a priority at the 2000 CDC sponsored workshop entitled "Identifying Public Health Opportunities to Reduce the Burden of Ovarian Cancer". Information gained from the proposed study testing the efficacy of two web-based approaches to ovarian cancer symptom management should advance understanding of the critical elements of interventions needed to reduce cancer-related morbidity in improve quality of life.