Study of Opioid-Induced Constipation 1 Project

Study Overview
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Brief Summary
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The aim of the project is to investigate opioid-induced constipation (OIC) in a real world / diverse group of patients with cancer. The objectives of the project are to determine: a) prevalence of OIC; b) clinical features / impact of OIC; c) management of OIC.

Detailed Description
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StOIC-1 is an observational study, and will involve a single visit (see below for schedule). The following data will be collected: a) demographic data - age, gender, ethnicity; b) cancer diagnosis; c) opioid medications - drug, formulation, dose; d) laxative medications - drug, formulation, dose; e) other medications; f) Eastern Co-operative Oncology Group performance status The participants will be asked the following questions: Simple question - Are you constipated? [Options - yes / no / unsure] European Association for Palliative Care definition question - Does the following question describe your bowel function: 'the passage of small, hard faeces infrequently and with difficulty?' [Options - yes / no / unsure] Camilleri definition question - Does the following statement describe your bowel function: 'a change since initiating opioid therapy from baseline bowel habits that is characterised by any of the following: reduced bowel movement frequency, development or worsening of straining to pass bowel movements, a sense of incomplete rectal evacuation, harder stool consistency?' [Options - yes / no / unsure Rome IV diagnostic criteria for OIC The participants will also be asked to complete: Bowel function index (BFI). The BFI is a validated, 3 item, patient-reported tool for assessing the treatment of OIC. A BFI score of ≥30 indicates suboptimally treated OIC. Patient Assessment of Constipation - Quality of Life Questionnaire (PAC-QOL). The PAC-QOL is a validated, 28-item, patient-reported tool for assessing the impact of constipation over time. Memorial Symptom Assessment Scale - Short Form (MSAS-SF). The MSAS-SF is a validated, 32 item, patient-reported tool for assessing physical and psychological symptoms in cancer patients. The participant will also undergo a palliative care specialist assessment for constipation / OIC. The palliative care specialist will be asked to review the patient with regard to their bowel function, and then asked the following questions: a) does the patient have constipation? [Options - yes / no / unsure]; b) (if appropriate) does the patient have opioid-induced constipation? [Options - yes / no / unsure]; c) (if appropriate) does the patient have additional causes of constipation? [Options - yes / no / unsure]; d) (if appropriate) what additional causes of constipation?I

Official Title
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An Observational Study of Diagnostic Criteria, Clinical Features and Management of Opioid-induced Constipation (OIC) in Patients With Cancer Pain

Conditions
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Opioid-induced Constipation, Cancer, Cancer Pain

Intervention / Treatment
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* Other: Clinical assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18yr; diagnosis of cancer; diagnosis of cancer pain; receipt of regular opioids for at least one week Exclusion Criteria: Inability to give informed consent; inability to complete questionnaire

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Clinical assessment|Clinical assessment (history, examination) is gold standard for diagnosing constipation - gold standard will be compared with simple question about constipation, Rome IV diagnostic criteria for OIC, and common definitions of constipation for constipation / OIC|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of opioid-induced constipation | Clinician assessment | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opioid-induced constipation