Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction

恶性肠梗阻的前瞻性比较有效性试验

• 批准号: 8642511
• 负责人: Robert Scott Krouse
• 金额: $ 23.32万
• 依托单位: UNIVERSITY OF ARIZONA
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-30 至 2018-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8642511
• 关键词: Prospective; Comparative; Effectiveness; Trial; Malignant

Patients with advanced cancer face challenges affecting quality of life (QOL). As the National Cancer Policy Board has identified, research addressing the needs of patients with incurable cancers is severely deficient and effectiveness has rarely been displayed by prospective trials. Malignant bowel obstruction (MBO) is a common problem for advanced cancer patients that involves considerable suffering. There are two major treatment approaches for MBO: surgical management and medical management with specific classes of medications. There is little evidence-based information to choose the optimal clinical care for most patients with a MBO. Goals for these patients may include the ability to eat, relief of nausea, pain control, being at home, and along with an increase in survival. Treatments may improve QOL outcomes in many, but there is no consistent measure defining improvement. The aim of this study is to compare the current treatment algorithms of surgical and non-surgical approaches to MBO in terms of minimizing days in hospital and improving QOL. This will be a five-year multi-site prospective comparative effectiveness study of patients who are admitted to the hospital with an MBO. We have devised a mixed-design study of a smaller randomized population and a larger observational cohort to ensure validity of observational results while enabling adequate accrual. To accomplish this goal we will need to accrue 180 patients (50 in randomized sub-study, 130 in observational study). The preponderance of MBO patients will be accrued to be prospectively followed utilizing general modeling strategy along with propensity score techniques to compare treatment approaches. In addition, we will have a smaller subset of patients who will be randomized to surgical versus non-surgical interventions. Our data collection strategies are designed to minimize patient burden by this alternate research approach with clinically meaningful outcome measures as well as limited health-related quality of life surveys. The primary inclusion criteria for the study is whether a surgical option is being considered in the setting of MBO and there is equipoise to outcomes. The interventions to be compared are an initial surgical versus a non-surgical approach for MBO. Data forms will include demographic and disease history, hospital stay, days with NG tubes, TPN and other hydration, ability to eat or drink with dietary histories, complications, recurrence, total hospital days, and survival. In addition, research coordinators will serially acquire subjective QOL data from the MD Anderson Symptom Inventory - Gastrointestinal, which should not take more than 10 minutes to complete. The primary outcome measure will be "good days", defined as being at home (out of the hospital) and alive. The difference we hope to find is two weeks in a 90 day span (20% difference). Secondary endpoints include days with NG tube, days of intravenous hydration, days eating solid foods, days drinking, and amount of intake, recurrence, morbidity, and survival. We will include a cost analysis plan as well. We anticipate results to be clinically useful to practitioners caring for MBO patients.

晚期癌症患者面临影响生活质量（QOL）的挑战。国家癌症政策 委员会已经确定，针对无法治愈的癌症患者需求的研究严重不足 并且其有效性很少被前瞻性试验所证实。恶性肠梗阻（MBO）是一种 晚期癌症患者的常见问题，涉及相当大的痛苦。有两大 MBO的治疗方法：手术治疗和药物治疗， 药物治疗对于大多数患者来说，选择最佳临床护理的循证信息很少 一个MBO。这些患者的目标可能包括进食能力，缓解恶心，疼痛控制， 家，并沿着增加生存。治疗可能会改善许多人的生活质量结果，但没有 一致的衡量标准来定义改进。本研究的目的是比较目前的治疗算法 手术和非手术治疗MBO在减少住院天数和提高生活质量方面的差异。 这将是一项为期五年的多中心前瞻性比较有效性研究， 医院管理层收购我们设计了一项混合设计研究，研究对象是一个较小的随机人群， 更大的观察性队列，以确保观察结果的有效性，同时实现充分的招募。到 为了实现这一目标，我们将需要招募180例患者（50例在随机子研究中，130例在观察性研究中）。 研究）。MBO患者的优势将累积到使用一般 建模策略沿着倾向评分技术来比较治疗方法。另外我们 将有一个较小的患者子集，随机分配到手术和非手术干预组。我们 数据收集策略旨在通过这种替代研究方法最大限度地减少患者负担， 具有临床意义的结局指标以及有限的健康相关生活质量调查。 该研究的主要入选标准是在以下情况下是否考虑手术选择： 目标管理和平衡的结果。要比较的干预措施是初始手术与 非手术治疗MBO。数据表将包括人口统计学和病史、住院时间、天数 有NG管，TPN和其他水合作用，饮食能力和饮食史，并发症，复发， 总住院天数和存活率。此外，研究协调员将连续获取主观生活质量数据 MD安德森症状量表-胃肠道，不应超过10分钟， 完成.主要的结局指标是“好日子”，定义为在家（出院） 还活着我们希望找到的差异是90天内的两周（20%的差异）。二次 终点包括使用NG管的天数、静脉内水合的天数、食用固体食物的天数、饮酒的天数， 以及摄入量、复发率、发病率和存活率。我们还将制定成本分析计划。我们 预计结果对护理MBO患者的从业者具有临床实用价值。