Validation of a Screening Scale for Misuse of Opioid Analgesics (VPOMIONCOL)

Validation of a Screening Scale for the Misuse of Opioid Analgesics in Patients With Chronic Pain Related to Cancer.

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).

Study Overview

• Status: Recruiting
• Conditions: Pain; Cancer; Opioid Analgesic Adverse Reaction
• Intervention / Treatment: Other: Questionnaires

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 Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Lise Laclautre; Phone Number: +33 4 73 75 11 95; Email: promo_interne_drci@chu-clermontferrand.fr

Study Locations

• France
  • Clermont-Ferrand, France
    • Recruiting
    • CHU de Clermont-Ferrand
    • Principal Investigator: Virginie Guastella
    • Contact: Lise Laclautre
  • Le Puy-en-Velay, France, 43000
    • Recruiting
    • CH Le Puy en Velay
    • Principal Investigator: Brigitte MONANGE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Cancer patients

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
cancer patients; Questionnaires	Other: Questionnaires; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
POMI scale score - Prescription Opioid Misuse Index	8-item self-assessment scale	day 1
POMI scale score - Prescription Opioid Misuse Index	8-item self-assessment scale	day 15

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Virginie Guastella, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: February 16, 2023
• First Submitted That Met QC Criteria: February 27, 2023
• First Posted (Actual): March 9, 2023

Study Record Updates

• Last Update Posted (Actual): July 18, 2023
• Last Update Submitted That Met QC Criteria: July 17, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: RNI 2022 GUASTELLA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No