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Clinical Trials/NCT04350112
NCT04350112
Completed
N/A

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

Royal Surrey County Hospital NHS Foundation Trust16 sites in 1 country1,007 target enrollmentAugust 21, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Opioid-induced Constipation
Sponsor
Royal Surrey County Hospital NHS Foundation Trust
Enrollment
1007
Locations
16
Primary Endpoint
Prevalence of opioid-induced constipation
Status
Completed
Last Updated
6 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
August 21, 2017
End Date
August 30, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Royal Surrey County Hospital NHS Foundation Trust
Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Prevalence of opioid-induced constipation

Time Frame: 1 week

Clinician assessment

Study Sites (16)

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