Validation of a Screening Scale for Misuse of Opioid Analgesics

Recruiting

• Conditions: Cancer; Opioid Analgesic Adverse Reaction; Pain

• Registration Number: NCT05761587
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief 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.

Study Timeline

• Status Verified: 2023-02
• Study First Submitted: 2023-02-16
• Study Start: 2023-02-23
• Study First Submitted QC: 2023-02-27
• Study First Posted: 2023-03-09
• Last Update Submitted: 2023-07-17
• Last Update Posted: 2023-07-18
• Primary Completion: 2024-04-01
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
POMI scale score - Prescription Opioid Misuse Index	day 15	8-item self-assessment scale

Secondary Outcome Measures

Name	Time	Method
Sociodemographic characteristics	day 1	Questionnaire about Sociodemographic characteristics of patients
QCD	day 15	Visual Analogue Scales (VAS) for assessing the intensity and daily impact of pain (0-10)
Lifestyle habits, other consumption	day 1	Questionnaire about Lifestyle habits, other consumption
Analgesic treatments	day 1	Questionnaire about Ongoing analgesic treatments
Use of analgesics	day 15	Question evaluating the use of analgesics in the context of anticipating pain

Trial Locations

Locations (2)

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

CH Le Puy en Velay; 🇫🇷 Le Puy-en-Velay, France