Validation of a Screening Scale for Misuse of Opioid Analgesics

Pain Clinical Trial

— VPOMIONCOL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05761587
• Other study ID #: RNI 2022 GUASTELLA
• Status: Recruiting
• Start date: February 23, 2023
• Est. completion date: April 1, 2025

Study information

• Verified date: February 2023
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise Laclautre
• Phone: 4 73 75 11 95
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: April 1, 2025
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Opioid Analgesic Adverse Reaction
• Pain

Intervention

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.

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand
France	CH Le Puy en Velay	Le Puy-en-Velay

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	POMI scale score - Prescription Opioid Misuse Index	8-item self-assessment scale	day 1
Primary	POMI scale score - Prescription Opioid Misuse Index	8-item self-assessment scale	day 15
Secondary	QCD	Visual Analogue Scales (VAS) for assessing the intensity and daily impact of pain (0-10)	day 1
Secondary	QCD	Visual Analogue Scales (VAS) for assessing the intensity and daily impact of pain (0-10)	day 15
Secondary	Sociodemographic characteristics	Questionnaire about Sociodemographic characteristics of patients	day 1
Secondary	Lifestyle habits, other consumption	Questionnaire about Lifestyle habits, other consumption	day 1
Secondary	Analgesic treatments	Questionnaire about Ongoing analgesic treatments	day 1
Secondary	Use of analgesics	Question evaluating the use of analgesics in the context of anticipating pain	day 1
Secondary	Use of analgesics	Question evaluating the use of analgesics in the context of anticipating pain	day 15