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，虽然它很容易被护理干预，但便秘经常被忽视和治疗。有限的研究集中在管理药物引起的便秘的模式和方法上。这项两期研究的目的是确定接受阿片类药物和长春花生物碱治疗的癌症患者便秘的发生率、痛苦和轨迹，评估便秘治疗方案的疗效，并比较根据药物剂量管理和根据评估数据管理，这两种方法都已被NCCN推荐为国家指南。在第一阶段，195名接受阿片类药物、长春花生物碱或两者兼有的癌症患者将被要求参加为期8周的研究。每周通过电话和访谈对他们的便秘强度进行评估，了解他们如何控制便秘，这将提供一个整体问题的图像。由于肠道穿孔的风险增加，怀疑或已知有粪便嵌塞的患者将被排除在研究之外，并转介给主治医生。在第一阶段由于撞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退出。数据将使用随机效应模型进行分析。在二期研究中，325名患者将被纳入研究。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) 65名接受阿片类药物治疗的患者的对照组，他们将只接受标准治疗；b)一组65名服用阿片类药物的患者，他们将根据评估数据接受标准治疗和便秘治疗方案；c)一组65名服用阿片类药物的患者将接受标准治疗，并根据阿片类药物的剂量接受便秘治疗方案。接受长春花生物碱治疗的患者将被随机分为两组：d)对照组65名接受长春花生物碱标准治疗的患者；e)一组65名患者接受标准治疗和基于评估数据的便秘治疗方案。所有五组的患者将被要求在每周的电话中填写相同的表格。研究中测量的变量是基于不愉快症状理论中的概念。同意后，患者将被要求提供包括合并症在内的人口统计信息，并完成便秘评估量表（CAS）、生活质量（FACT-G）、便秘和其他症状困扰的纪念症状评估量表（MSAS）、CES-抑郁指数和泻药访谈，以确定患者治疗便秘的情况。在接下来的七周中，患者将报告他们的CAS评分和泻药使用情况。在第4周和第8周，将重复进行CES-D、MSAS和FACT-G测试。最后，便秘的图表审计将用于监测患者订购的阿片类药物和长春花生物碱的剂量，以及在研究的8周内是否订购或建议使用任何泻药。数据分析将包括随机效应建模。便秘在癌症患者中是一个非常常见的问题，尽管它很容易受到护理干预，但在肿瘤环境中，便秘经常被忽视和未经治疗。这项两期研究的目的是确定接受阿片类药物和长春花生物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管理和根据评估数据管理，这两种管理都已被NCCN推荐为国家指南。

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.