Study of Opioid-Induced Constipation 1 Project (StOIC-1)

April 15, 2020 updated by: Royal Surrey County Hospital NHS Foundation Trust

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

Completed

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:

  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

Study Type

Observational

Enrollment (Actual)

1007

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Cornwall
      • Truro, Cornwall, United Kingdom, TR1 3LQ
        • Royal Cornwall Hospital
    • East Sussex
      • Brighton, East Sussex, United Kingdom, BN2 5BE
        • Brighton & Sussex University Hospitals
    • Gloucestershire
      • Cheltenham, Gloucestershire, United Kingdom, GL53 0QJ
        • Leckhampton Court Hospice
    • Hertfordshire
      • Berkhamstead, Hertfordshire, United Kingdom, HP43GW
        • Hospice of St. Francis
    • Kent
      • Maidstone, Kent, United Kingdom, ME20 7PU
        • Heart of Kent Hospice
      • Rochester, Kent, United Kingdom, ME1 2NU
        • Wisdom Hospice
    • London
      • Cheam, London, United Kingdom, SM3 9DX
        • St. Raphael's Hospice
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom
        • Nottingham University Hospitals
    • Somerset
      • Yeovil, Somerset, United Kingdom, BA20 2HU
        • St Margaret's Hospice
    • Staffordshire
      • Lichfield, Staffordshire, United Kingdom, WS14 9LH
        • St. Giles Hospice
    • Surrey
      • Guildford, Surrey, United Kingdom, GU2 7XX
        • Royal Surrey County Hospital
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B29 7DA
        • Birmingham St. Mary's Hospice
    • West Sussex
      • Crawley, West Sussex, United Kingdom, RH10 6BH
        • St. Catherine's Hospice
    • Yorkshire
      • Leeds, Yorkshire, United Kingdom, LS17 6QD
        • St. Gemma's Hospice
      • Leeds, Yorkshire, United Kingdom, LS6 2AE
        • Wheatfields Hospice
      • Sheffield, Yorkshire, United Kingdom, S11 9NE
        • St. Luke's Hospice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

1000 subjects that are either inpatients or outpatients at study sites (hospitals and hospices in the United Kingdom)

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Sponsor

Royal Surrey County Hospital NHS Foundation Trust

Collaborators

Kyowa Hakko Kirin UK, Ltd.

Investigators

  • Principal Investigator: Andrew N Davies, MD, Consultant Palliative Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 21, 2017

Primary Completion (Actual)

August 30, 2019

Study Completion (Actual)

August 30, 2019

Study Registration Dates

First Submitted

April 13, 2020

First Submitted That Met QC Criteria

April 15, 2020

First Posted (Actual)

April 16, 2020

Study Record Updates

Last Update Posted (Actual)

April 16, 2020

Last Update Submitted That Met QC Criteria

April 15, 2020

Last Verified

April 1, 2020

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)?

No

IPD Plan Description

Currently, there are no plans to make IPD available to other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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