Managing Medication-induced Constipation in Cancer: A Clinical Trial

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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.