Clinical trial NCT05761587: Validation of a Screening Scale for Misuse of Opioid Analgesics
Official title: Validation of a Screening Scale for the Misuse of Opioid Analgesics in Patients With Chronic Pain Related to Cancer.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Pain
Opioid Analgesic Adverse Reaction
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2023-03-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients

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.

Eligibility 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.

Primary outcomes:
measure: POMI scale score - Prescription Opioid Misuse Index
timeFrame: day 1
measure: POMI scale score - Prescription Opioid Misuse Index
timeFrame: day 15
Secondary outcomes:
measure: QCD
timeFrame: day 1
measure: QCD
timeFrame: day 15
measure: Sociodemographic characteristics
timeFrame: day 1
measure: Lifestyle habits, other consumption
timeFrame: day 1
measure: Analgesic treatments
timeFrame: day 1
measure: Use of analgesics
timeFrame: day 1
measure: Use of analgesics
timeFrame: day 15
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Le Puy-en-Velay
country: France
facility: CH Le Puy en Velay
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Virginie Guastella
role: PRINCIPAL_INVESTIGATOR
References: