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Validation of a Screening Scale for Misuse of Opioid Analgesics

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05761587
Acronym
VPOMIONCOL
Enrollment
150
Registered
2023-03-09
Start date
2023-02-23
Completion date
2025-04-01
Last updated
2023-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Opioid Analgesic Adverse Reaction, Pain

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.

Interventions

OTHERQuestionnaires

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.

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
POMI scale score - Prescription Opioid Misuse Indexday 18-item self-assessment scale

Secondary

MeasureTime frameDescription
QCDday 1Visual Analogue Scales (VAS) for assessing the intensity and daily impact of pain (0-10)
Sociodemographic characteristicsday 1Questionnaire about Sociodemographic characteristics of patients
Lifestyle habits, other consumptionday 1Questionnaire about Lifestyle habits, other consumption
Analgesic treatmentsday 1Questionnaire about Ongoing analgesic treatments
Use of analgesicsday 1Question evaluating the use of analgesics in the context of anticipating pain

Countries

France

Contacts

Primary ContactLise Laclautre
promo_interne_drci@chu-clermontferrand.fr4 73 75 11 95

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026