StOIC-1: Study of Opioid-Induced Constipation 1 Project
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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:
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Simple question - "Are you constipated?" [Options - yes / no / unsure]
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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]
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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
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Rome IV diagnostic criteria for OIC
The participants will also be asked to complete:
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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.
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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.
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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
Study Design
Outcome Measures
Primary Outcome Measures
- Prevalence of opioid-induced constipation [1 week]
Clinician assessment
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Royal Cornwall Hospital | Truro | Cornwall | United Kingdom | TR1 3LQ |
| 2 | Brighton & Sussex University Hospitals | Brighton | East Sussex | United Kingdom | BN2 5BE |
| 3 | Leckhampton Court Hospice | Cheltenham | Gloucestershire | United Kingdom | GL53 0QJ |
| 4 | Hospice of St. Francis | Berkhamstead | Hertfordshire | United Kingdom | HP43GW |
| 5 | Heart of Kent Hospice | Maidstone | Kent | United Kingdom | ME20 7PU |
| 6 | Wisdom Hospice | Rochester | Kent | United Kingdom | ME1 2NU |
| 7 | St. Raphael's Hospice | Cheam | London | United Kingdom | SM3 9DX |
| 8 | Nottingham University Hospitals | Nottingham | Nottinghamshire | United Kingdom | |
| 9 | St Margaret's Hospice | Yeovil | Somerset | United Kingdom | BA20 2HU |
| 10 | St. Giles Hospice | Lichfield | Staffordshire | United Kingdom | WS14 9LH |
| 11 | Royal Surrey County Hospital | Guildford | Surrey | United Kingdom | GU2 7XX |
| 12 | Birmingham St. Mary's Hospice | Birmingham | West Midlands | United Kingdom | B29 7DA |
| 13 | St. Catherine's Hospice | Crawley | West Sussex | United Kingdom | RH10 6BH |
| 14 | St. Gemma's Hospice | Leeds | Yorkshire | United Kingdom | LS17 6QD |
| 15 | Wheatfields Hospice | Leeds | Yorkshire | United Kingdom | LS6 2AE |
| 16 | St. Luke's Hospice | Sheffield | Yorkshire | United Kingdom | S11 9NE |
Sponsors and Collaborators
- Royal Surrey County Hospital NHS Foundation Trust
- Kyowa Hakko Kirin UK, Ltd.
Investigators
- Principal Investigator: Andrew N Davies, MD, Consultant Palliative Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- StOIC-1 Project