VPOMIONCOL: Validation of a Screening Scale for Misuse of Opioid Analgesics

Sponsor

University Hospital, Clermont-Ferrand (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05761587

Collaborator

(none)

150

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Cancer Pain Opioid Analgesic Adverse Reaction	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 Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Apr 1, 2025

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

POMI scale score - Prescription Opioid Misuse Index [day 1]
8-item self-assessment scale
POMI scale score - Prescription Opioid Misuse Index [day 15]
8-item self-assessment scale

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Clermont-Ferrand	Clermont-Ferrand		France

Sponsors and Collaborators

University Hospital, Clermont-Ferrand

Investigators

Principal Investigator: Virginie Guastella, University Hospital, Clermont-Ferrand

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Clermont-Ferrand

ClinicalTrials.gov Identifier:

NCT05761587

Other Study ID Numbers:

RNI 2022 GUASTELLA

First Posted:

Mar 9, 2023

Last Update Posted:

Mar 9, 2023

Last Verified:

Feb 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 9, 2023