Study of Opioid-Induced Constipation 1 Project
- Conditions
- Cancer PainOpioid-induced ConstipationCancer
- Registration Number
- NCT04350112
- Lead Sponsor
- Royal Surrey County Hospital NHS Foundation Trust
- 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.
- 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:
1. Simple question - "Are you constipated?" \[Options - yes / no / unsure\]
2. 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?' \[Options - yes / no / unsure\]
3. 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
4. Rome IV diagnostic criteria for OIC
The participants will also be asked to complete:
1. 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.
2. 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.
3. 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1007
- Age > 18yr; diagnosis of cancer; diagnosis of cancer pain; receipt of regular opioids for at least one week
- Inability to give informed consent; inability to complete questionnaire
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prevalence of opioid-induced constipation 1 week Clinician assessment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (16)
St. Raphael's Hospice
🇬🇧Cheam, London, United Kingdom
Birmingham St. Mary's Hospice
🇬🇧Birmingham, West Midlands, United Kingdom
Wheatfields Hospice
🇬🇧Leeds, Yorkshire, United Kingdom
St. Gemma's Hospice
🇬🇧Leeds, Yorkshire, United Kingdom
St. Luke's Hospice
🇬🇧Sheffield, Yorkshire, United Kingdom
Royal Cornwall Hospital
🇬🇧Truro, Cornwall, United Kingdom
Brighton & Sussex University Hospitals
🇬🇧Brighton, East Sussex, United Kingdom
Leckhampton Court Hospice
🇬🇧Cheltenham, Gloucestershire, United Kingdom
St. Giles Hospice
🇬🇧Lichfield, Staffordshire, United Kingdom
Hospice of St. Francis
🇬🇧Berkhamstead, Hertfordshire, United Kingdom
Nottingham University Hospitals
🇬🇧Nottingham, Nottinghamshire, United Kingdom
St Margaret's Hospice
🇬🇧Yeovil, Somerset, United Kingdom
Royal Surrey County Hospital
🇬🇧Guildford, Surrey, United Kingdom
St. Catherine's Hospice
🇬🇧Crawley, West Sussex, United Kingdom
Heart of Kent Hospice
🇬🇧Maidstone, Kent, United Kingdom
Wisdom Hospice
🇬🇧Rochester, Kent, United Kingdom