Managing Medication-induced Constipation in Cancer: A Clinical Trial

描述(申请人提供)：便秘是癌症患者中非常常见的问题，尽管它非常适合护理干预，但便秘经常得不到发现和治疗。有限的研究集中在管理药物引起的便秘的模式和方法上。这项两阶段研究的目的是确定接受阿片类药物和长春花碱治疗的癌症患者便秘的发生率、痛苦和便秘轨迹，评估便秘治疗方案的有效性，并比较根据评估数据进行的药物剂量管理和根据评估数据进行的管理，这两种方法都已在NCCN的国家指南中得到推荐。在第一阶段，195名接受阿片类药物和/或长春花碱的癌症患者将被寻求在八周内参加。每周通过电话对他们的便秘强度进行评估，并采访他们试图控制便秘的情况，这将提供整个问题的图景。怀疑或已知有粪便嵌塞的患者将被从研究中移除并转诊给主治医生，因为肠穿孔的风险增加。第一阶段由于冲击造成的损耗将揭示在第二阶段需要多少过采样来补偿预期的丢失。数据将使用随机效果建模进行分析。在第二阶段，将为这项研究寻找325名患者。接受阿片类药物治疗的患者将被随机分配到三个治疗组之一：a)对照组65名阿片类药物患者，他们将只接受标准护理；b)65名阿片类药物患者，他们将根据评估数据接受标准护理和便秘治疗方案；c)65名阿片类药物患者，他们将接受标准护理，外加基于阿片类药物剂量的便秘治疗方案。接受长春花碱治疗的患者将被随机分配到两组：d)接受标准治疗的65名接受长春花碱治疗的对照组患者；以及e)根据评估数据接受标准治疗加便秘治疗方案的65名患者组。在每周的电话通话中，所有五组患者都将被要求填写相同的表格。研究中测量的变量是基于不愉快症状理论中的概念。在同意后，患者将被要求提供包括共病在内的人口统计学信息，并将完成便秘评估量表(CAS)、FACT-G(生活质量)、便秘和其他症状苦恼的记忆症状评估量表(MSAS)、CES抑郁指数和泻药面谈，以确定患者一直是如何治疗便秘的。在接下来的七周里，患者将报告他们的CAS评分和他们的泻药使用情况。在第4周和第8周，将重复CES-D、MSA和FACT-G。最后，便秘审计图表将用于监测为患者订购的阿片类药物和长春花碱的剂量，以及在8周的研究期间是否订购或建议服用任何泻药。数据分析将包括随机效果建模。与公共卫生相关的便秘在癌症患者中是一个非常常见的问题，尽管它非常适合护理干预，但在肿瘤科的环境中，便秘往往得不到发现和治疗。这项两阶段研究的目的是确定接受阿片类药物和长春花碱治疗的癌症患者的便秘模式，评估便秘治疗方案的疗效，并比较根据药物剂量进行的治疗与根据评估数据进行的治疗，这两种方法都已在NCCN的国家指南中得到推荐。

DESCRIPTION (provided by applicant): Constipation is a very common problem among cancer patients and although it is very amenable to nursing intervention, constipation often goes unrecognized and untreated. Limited research has been conducted focusing on the patterns and approaches to managing medication-induced constipation. The purposes of this two-phase study are to determine the incidence, distress, and trajectory of constipation among cancer patients receiving opioids and vinca alkaloids, to evaluate the efficacy of the Constipation Treatment Protocol, and to compare management according to dose of medication versus management according to assessment data, both of which have been recommended in national guidelines from the NCCN. During Phase I, 195 patients with cancer who are receiving either opioids, vinca alkaloids or both will be sought to participate over an eight- week period. Weekly assessments of their constipation intensity via telephone and interviews about their attempts to manage the constipation will provide a picture of the overall problem. Patients who are suspected or known to have fecal impactions will be removed from the study and referred to the attending physician because of the increased risk of bowel perforation. Attrition due to impaction during Phase I will reveal how much oversampling will be needed during Phase II to compensate for expected drop-out. Data will be analyzed using Random Effects Modeling. During Phase II, 325 patients will be sought for the study. Patients receiving opioids will be randomly assigned to one of three treatment groups: a) a control group of 65 patients on opioids who will receive standard care only; b) a group of 65 patients on opioids who will receive standard care plus the Constipation Treatment Protocol based on assessment data; and c) a group of 65 patients on opioids who will receive standard care plus the Constipation Treatment Protocol based on dose of opioid. Patients receiving vinca alkaloids will be randomly assigned to two groups: d) a control group of 65 patients on vinca alkaloids receiving standard care; and e) a group of 65 patients receiving standard care plus the Constipation Treatment Protocol based on assessment data. Patients in all five groups will be asked to complete the same forms during weekly telephone calls. Variables measured in the study are based on concepts in the Theory of Unpleasant Symptoms. After consenting, patients will be asked for demographic information including co- morbidities and will complete the Constipation Assessment Scale (CAS), the FACT-G (quality of life), the Memorial Symptom Assessment Scale (MSAS) for constipation and other symptom distress, the CES- Depression index, and the Laxative Interview to determine how the patient has been treating constipation. For each of the following seven weeks, patients will report their scores on the CAS and their laxative use. At weeks 4 and 8, the CES-D, MSAS, and FACT-G will be repeated. Finally, the Chart Audit for Constipation will be used to monitor the doses of opioids and vinca alkaloids that are ordered for patients and whether any laxatives are ordered or suggested during the 8 weeks of the study. Data analysis will include random effects modeling. PUBLIC HEALTH RELEVANCE Constipation is a very common problem among cancer patients and although it is very amenable to nursing intervention, constipation often goes unrecognized and untreated in oncology settings. The purposes of this two-phase study are to determine the pattern of constipation among cancer patients receiving opioids and vinca alkaloids, to evaluate the efficacy of the Constipation Treatment Protocol, and to compare management according to dose of medication with management according to assessment data, both of which have been recommended in national guidelines from the NCCN.