- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04350112
Study of Opioid-Induced Constipation 1 Project (StOIC-1)
An Observational Study of Diagnostic Criteria, Clinical Features and Management of Opioid-induced Constipation (OIC) in Patients With Cancer Pain
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.
Study Overview
Status
Conditions
Intervention / Treatment
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:
- 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
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Cornwall
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Truro, Cornwall, United Kingdom, TR1 3LQ
- Royal Cornwall Hospital
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East Sussex
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Brighton, East Sussex, United Kingdom, BN2 5BE
- Brighton & Sussex University Hospitals
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Gloucestershire
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Cheltenham, Gloucestershire, United Kingdom, GL53 0QJ
- Leckhampton Court Hospice
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Hertfordshire
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Berkhamstead, Hertfordshire, United Kingdom, HP43GW
- Hospice of St. Francis
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Kent
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Maidstone, Kent, United Kingdom, ME20 7PU
- Heart of Kent Hospice
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Rochester, Kent, United Kingdom, ME1 2NU
- Wisdom Hospice
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London
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Cheam, London, United Kingdom, SM3 9DX
- St. Raphael's Hospice
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Nottinghamshire
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Nottingham, Nottinghamshire, United Kingdom
- Nottingham University Hospitals
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Somerset
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Yeovil, Somerset, United Kingdom, BA20 2HU
- St Margaret's Hospice
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Staffordshire
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Lichfield, Staffordshire, United Kingdom, WS14 9LH
- St. Giles Hospice
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Surrey
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Guildford, Surrey, United Kingdom, GU2 7XX
- Royal Surrey County Hospital
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West Midlands
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Birmingham, West Midlands, United Kingdom, B29 7DA
- Birmingham St. Mary's Hospice
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West Sussex
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Crawley, West Sussex, United Kingdom, RH10 6BH
- St. Catherine's Hospice
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Yorkshire
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Leeds, Yorkshire, United Kingdom, LS17 6QD
- St. Gemma's Hospice
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Leeds, Yorkshire, United Kingdom, LS6 2AE
- Wheatfields Hospice
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Sheffield, Yorkshire, United Kingdom, S11 9NE
- St. Luke's Hospice
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of opioid-induced constipation
Time Frame: 1 week
|
Clinician assessment
|
1 week
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Andrew N Davies, MD, Consultant Palliative Medicine
Publications and helpful links
General Publications
- Chang VT, Hwang SS, Feuerman M, Kasimis BS, Thaler HT. The memorial symptom assessment scale short form (MSAS-SF). Cancer. 2000 Sep 1;89(5):1162-71. doi: 10.1002/1097-0142(20000901)89:53.0.co;2-y.
- Marquis P, De La Loge C, Dubois D, McDermott A, Chassany O. Development and validation of the Patient Assessment of Constipation Quality of Life questionnaire. Scand J Gastroenterol. 2005 May;40(5):540-51. doi: 10.1080/00365520510012208.
- Camilleri M, Drossman DA, Becker G, Webster LR, Davies AN, Mawe GM. Emerging treatments in neurogastroenterology: a multidisciplinary working group consensus statement on opioid-induced constipation. Neurogastroenterol Motil. 2014 Oct;26(10):1386-95. doi: 10.1111/nmo.12417. Epub 2014 Aug 28.
- Larkin PJ, Sykes NP, Centeno C, Ellershaw JE, Elsner F, Eugene B, Gootjes JR, Nabal M, Noguera A, Ripamonti C, Zucco F, Zuurmond WW; European Consensus Group on Constipation in Palliative Care. The management of constipation in palliative care: clinical practice recommendations. Palliat Med. 2008 Oct;22(7):796-807. doi: 10.1177/0269216308096908. Erratum In: Palliat Med. 2009 Jun;23(4):376.
- Mearin F, Lacy BE, Chang L, Chey WD, Lembo AJ, Simren M, Spiller R. Bowel Disorders. Gastroenterology. 2016 Feb 18:S0016-5085(16)00222-5. doi: 10.1053/j.gastro.2016.02.031. Online ahead of print.
- Argoff CE, Brennan MJ, Camilleri M, Davies A, Fudin J, Galluzzi KE, Gudin J, Lembo A, Stanos SP, Webster LR. Consensus Recommendations on Initiating Prescription Therapies for Opioid-Induced Constipation. Pain Med. 2015 Dec;16(12):2324-37. doi: 10.1111/pme.12937. Epub 2015 Nov 19.
- Rentz AM, Yu R, Muller-Lissner S, Leyendecker P. Validation of the Bowel Function Index to detect clinically meaningful changes in opioid-induced constipation. J Med Econ. 2009;12(4):371-83. doi: 10.3111/13696990903430481.
- Ueberall MA, Muller-Lissner S, Buschmann-Kramm C, Bosse B. The Bowel Function Index for evaluating constipation in pain patients: definition of a reference range for a non-constipated population of pain patients. J Int Med Res. 2011;39(1):41-50. doi: 10.1177/147323001103900106.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- StOIC-1 Project
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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