Validation of a Screening Scale for Misuse of Opioid Analgesics

NCT ID: NCT05761587

Last Updated: 2023-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-23

Study Completion Date

2025-04-01

Brief Summary

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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

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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.

Conditions

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Cancer Pain Opioid Analgesic Adverse Reaction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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cancer patients

Questionnaires

Questionnaires

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Virginie Guastella

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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CHU de Clermont-Ferrand

Clermont-Ferrand, , France

Site Status RECRUITING

CH Le Puy en Velay

Le Puy-en-Velay, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Lise Laclautre

Role: CONTACT

4 73 75 11 95 ext. +33

Facility Contacts

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Lise Laclautre

Role: primary

Other Identifiers

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RNI 2022 GUASTELLA

Identifier Type: -

Identifier Source: org_study_id

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