European Study of Opioid Induced Constipation

Study Overview
=================
Brief Summary
-----------------
Constipation is common (40-90%) in advanced cancer patients , and has a significant negative impact on quality of life. The aetiology of constipation is often multifactorial in advanced cancer patients. However, it is well recognised that opioid analgesics are a common cause of constipation in this group. The prevalence of opioid-induced constipation (OIC) is stated to be 40-70%, although a recent large study reported an even higher figure. OIC has been reported to exceed pain in terms of distress caused, and studies have found that some patients choose to reduce or discontinue opioid medication in order to attempt to better control constipation. Moreover, OIC is associated with a variety of physical (gastrointestinal, systemic), psychological and social problems.

Detailed Description
-----------------
This European study follows on from a United Kingdom study, and aims to confirm findings of the previous study in a larger, more heterogeneous sample: it also aims to explore additional strategies to manage OIC. Moreover, the study aims to identify differences in perception of normal bowel habit / constipation, and differences in OIC management in the different European countries. Previous studies suggest that there are cultural differences in people's beliefs about constipation / normal bowel function. The aim of the project is to investigate OIC in a real world / heterogenous group of European patients with cancer.

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

Conditions
-----------------
Opioid-Induced Constipation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or over Diagnosis of cancer Diagnosis of cancer pain or cancer treatment-related pain Taking regular opioids for at least one week (i.e. opioid for mild to moderate pain / weak opioid; or opioid for moderate to severe pain / strong opioid) Exclusion Criteria: Unable to provide consent Unable to complete questionnaire

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of opioid induced constipation (OIC) | OIC diagnosed using Rome IV diagnostic criteria | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of OIC on quality of life | Patient Assessment of Constipation Quality of Life tool score Scale 0-4 (better to worse) | 5 minutes | 
| Efficacy of treatment for OIC | Bowel Function Index tool score Score 0-100 (better to worse) | 3 minutes | 
| Adherence with treatment for OIC No scale - yes / no options | Study questionnaire | 5 minutes | 
| Use of non-prescribed treatments for OIC | Study questionnaire No scale - yes / no options | 5 minutes |