Managing Medication-induced Constipation in Cancer: A Clinical Trial

治疗癌症药物引起的便秘：一项临床试验

• 批准号: 8204556
• 负责人: SUSAN C MCMILLAN
• 金额: $ 60.87万
• 依托单位: UNIVERSITY OF SOUTH FLORIDA
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-12-10 至 2013-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8204556
• 关键词: Cancer Patient; Clinical; Clinical Research; Clinical Trials; Comorbidity; Consent; Constipation; Control Groups; Data; Data Analyses; Disease; Distress; Dose; Drops; Emergency Situation; Empirical Research; Expert Opinion; Fecal Impaction; Feces; Guidelines; Health; Home environment; Incidence; Instruction; Intervention; Intervention Studies; Interview; Intestines; Judgment; Malignant Neoplasms; Measures; Medical center; Mental Depression; Modeling; Monitor; National Comprehensive Cancer Network; Nurses; Nursing Societies; Oncologic Nursing; Oncology Nurse; Operative Surgical Procedures; Opioid; Outcome; Oxycodone; Pain; Palliative Care; Patients; Pattern; Perforation; Persons; Pharmaceutical Preparations; Phase; Physicians; Population; Practice Guidelines; Prevalence; Quality of life; Randomized; Reporting; Research; Research Personnel; Risk; Severities; Stool Softener; Symptoms; Telephone; Telephone Interviews; Testing; Treatment Protocols; Vinblastine; Vinca Alkaloids; Vincristine; Vindesine; Vinorelbine; authority; base; cancer therapy; efficacy testing; evidence based guidelines; indexing; killings; laxative; male; men; nursing intervention; oncology; standard care; theories

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.

描述（由申请人提供）：便秘是癌症患者的一个非常普遍的问题，尽管它非常适合护理干预，但便秘通常未被认可和未经治疗。进行了有限的研究，重点是管理药物引起的便秘的模式和方法。这项两阶段研究的目的是确定接受阿片类药物和VINCA生物碱的癌症患者的发病率，困扰和轨迹，以评估便秘治疗方案的功效，并根据在NACCN中推荐的评估数据，根据评估数据的药物与管理剂量来比较治疗剂量。在第一阶段，将寻求195例接受阿片类药物，VINCA生物碱或两者两者的癌症患者参加八周的时间。每周通过电话评估其便秘强度，并进行有关他们管理便秘尝试的访谈，将为整体问题提供图片。由于肠穿孔的风险增加，涉嫌或已知有粪便染色的患者将被从研究中删除，并转交给主持人。由于阶段I期间的压力，损耗将揭示在第二阶段期间需要多少过采样，以补偿预期的辍学。数据将使用随机效应建模分析。在第二阶段，将寻求325名患者进行研究。接受阿片类药物的患者将被随机分配给三个治疗组之一：a）仅接受标准护理的阿片类药物的65例对照组； b）一组65例阿片类药物的患者将根据评估数据获得标准护理以及便秘治疗方案； c）一组65例阿片类药物患者将接受标准护理以及基于阿片类药物剂量的便秘治疗方案。接受VINCA生物碱的患者将随机分配给两组：D）由65例接受标准护理的VINCA生物碱的对照组； e）一组65例接受标准护理的患者以及基于评估数据的便秘治疗方案。在每周电话中，所有五组的患者都将被要求填写相同的表格。研究中测得的变量基于令人不快的症状理论中的概念。同意后，将要求患者提供包括共生率在内的人群信息，并完成便秘评估量表（CAS），FACT-G（生活质量），纪念症状评估评估量表（MSA），以进行便秘和其他症状遇险，CES-抑郁症指数以及泻药访谈，以确定患者如何治疗5。在接下来的七个星期中，患者将报告其CAS的分数及其泻药。在第4和第8周，将重复CES-D，MSA和FACT-G。最后，用于便秘的图表审核将用于监测为患者订购的阿片类药物和VINCA生物碱剂量，以及在研究的8周内是否有任何泻药或建议进行任何泻药。数据分析将包括随机效应建模。公共卫生相关性便秘是癌症患者的一个非常普遍的问题，尽管它非常适合护理干预，但便秘通常在肿瘤学环境中未被认可和未经治疗。这项两阶段研究的目的是确定接受阿片类药物和VINCA生物碱的癌症患者之间的便秘模式，以评估便秘治疗方案的疗效，并根据评估数据的治疗剂量将治疗方法与NCCN的国家指南中的两者进行比较。