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Trial Title:
Validation of a Screening Scale for Misuse of Opioid Analgesics
NCT ID:
NCT05761587
Condition:
Cancer
Pain
Opioid Analgesic Adverse Reaction
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Questionnaires
Description:
questionnaire including socio-demographic data, medical and family history, lifestyle,
treatments, 5 questions from the Questionnaire Concis sur les Douleurs (QCD), the French
version of the POMI scale, the diagnostic criteria of the DSM-V and two questions
concerning anxiety associated with pain and therapeutic education.
Arm group label:
cancer patients
Summary:
In oncology, pain is one of the main symptoms of discomfort. It has a significant impact
on the quality of life.The use of opioid analgesics is recommended for the treatment of
moderate to severe cancer pain.The misuse of opioid analgesics is an international public
health problem.Different scales have been developed to help the prescriber screen for the
risk of misuse in the general population. Patients with cancer-related pain are also at
risk for aberrant opioid-related behaviors, misuse or addiction.
The main objectif of this study is to validate of the screening scale for the misuse of
opioid analgesics in patients with chronic pain related to cancer. (Prescription Opioid
Misuse Index - POMI).
Detailed description:
The study takes place in 2 phases.
Test phase :
Questionnaire no. 1 constitutes the data for the TEST phase: it includes
socio-demographic data, medical and family history, lifestyle, treatments, 5 questions
from the Concise Pain Questionnaire (QCD), the French version of the POMI scale, the
diagnostic criteria of the DSM-V and two questions concerning anxiety associated with
pain and therapeutic education.
Retest phase :
questionnaire no. 2 10 to 15 days later.
Criteria for eligibility:
Study pop:
Cancer patients
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Patients aged 18 and over,
- Patients with chronic cancer-related pain that has been evolving for at least 3
months,
- Patients with a regular prescription of at least one opioid analgesic medicine taken
daily for at least 1 month,
- Patients followed in oncology for an active cancerous pathology.
Exclusion Criteria:
- Stopping opioid prescriptions on the day of the test phase (no Retest possible),
- Patients in the process of weaning (risk of being weaned during the Retest phase),
- Patients unable to complete the questionnaire on their own,
- Patients followed in a pain or addiction centre,
- Patients in terminal palliative situations of their cancer,
- Patients with chronic pain that is more disabling than cancer-related pain,
- Patients refusing to participate,
- Patients under guardianship or curatorship,
- Pregnant or breastfeeding patients,
- Patient with a language barrier limiting understanding of the questionnaire in
French.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
CHU de Clermont-Ferrand
Address:
City:
Clermont-Ferrand
Country:
France
Status:
Recruiting
Contact:
Last name:
Lise Laclautre
Investigator:
Last name:
Virginie Guastella
Email:
Principal Investigator
Facility:
Name:
CH Le Puy en Velay
Address:
City:
Le Puy-en-Velay
Zip:
43000
Country:
France
Status:
Recruiting
Investigator:
Last name:
Brigitte MONANGE
Email:
Principal Investigator
Start date:
February 23, 2023
Completion date:
April 1, 2025
Lead sponsor:
Agency:
University Hospital, Clermont-Ferrand
Agency class:
Other
Source:
University Hospital, Clermont-Ferrand
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05761587
