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

基于网络的卵巢癌症状控制：护士指导与自我指导

基本信息

批准号：
8282641
负责人：
Heidi S Donovan
金额：
$ 55.36万
依托单位：
UNIVERSITY OF PITTSBURGH AT PITTSBURGH
依托单位国家：
美国
项目类别：
财政年份：
2008
资助国家：
美国
起止时间：
2008-09-29 至 2014-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8282641
关键词：
Address Aftercare Age Anxiety Cancer Burden Cancer Patient Caring Centers for Disease Control and Prevention (U.S.)Chemotherapy-Oncologic Procedure Clinic Clinical Collaborations Communication Computers Country Data Development Diagnosis Disease Disease Progression Distress Education Educational Intervention Educational process of instructing Educational workshop Effectiveness Elements Ethnic Origin Evaluation Funding Gynecologic Oncology Group Health Health Personnel Home environment Individual Internet Intervention Knowledge Lead Learning Long-Term Effects Malignant Neoplasms Malignant neoplasm of ovary Measures Mediating Mental Depression Morbidity - disease rate Nurses Online Systems Outcome Outcome Measure Patient Education Patients Phase Pilot Projects Process Public Health Quality of life Randomized Randomized Clinical Trials Recruitment Activity Recurrence Relative (related person)Research Research Personnel Sampling Science Severities Specific qualifier value Staging Symptoms Time Translations Treatment Efficacy Treatment-Related Cancer United States National Institutes of Health Universities Woman Writing arm base chemotherapy comparative efficacy design efficacy testing experience improved innovation intervention effect novel strategies nursing intervention optimism patient population prevent programs research and development response sound success symptom management theories trait usability ward

项目摘要

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.

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。大多数将在晚期被诊断，并将在治疗后2年内复发。侵袭性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）[书面表征干预缓解症状]，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理解患者对她最重要的症状群的表征。目前，书写症状（c）由护士通过互联网留言板提供。目前对复发性卵巢癌妇女的一项试点研究表明，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。一个关键的问题是，护士的个性化是否对WRITE症状（c）干预的成功至关重要，或者女性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（称为“自我指导WRITE症状（c）”）指导该计划。自我指导模块的开发是完整的，初步评估支持其可行性;可接受性;以及内容，功能和理论有效性。拟议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女性目标症状表现（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QOL、与医疗保健提供者沟通和使用症状管理策略方面的相对疗效; 2）探索潜在的长期影响; 3）评价症状表征的变化是否介导QOL的变化; 4）评价干预效果的调节因素。为了实现研究目标，将从全国各地的妇科肿瘤组诊所招募480名患有复发性卵巢癌的女性，她们正在经历3种或3种以上疾病或治疗相关症状。受试者将完成人口统计学和临床信息、症状表现和QOL的基线测量。基线评估后，女性将被随机分配到三种干预措施之一：护士指导的WRITE症状（c），自我指导的WRITE症状（c）或照常护理。两个WRITE症状组的受试者在研究的前7周内参与干预措施。每月评估结果。本研究评估了一种创新的症状评估和管理方法。获得有关心理教育干预措施的关键组成部分和机制的知识，通过这些干预措施和机制，可以改善患者人群的症状管理。干预措施;公共卫生相关性：每年有超过22，000名妇女被诊断患有卵巢癌，超过14，000人死于这种疾病。在2000年疾病预防控制中心主办的题为“确定减少卵巢癌负担的公共卫生机会”的讲习班上，提高卵巢癌患者生活质量的研究被确定为优先事项。从拟议的研究中获得的信息测试两种基于网络的方法对卵巢癌症状管理的有效性，应促进对降低癌症相关发病率以提高生活质量所需干预措施的关键要素的理解。