NCT05761587

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2023

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

February 23, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 9, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

July 18, 2023

Status Verified

February 1, 2023

Enrollment Period

1.1 years

First QC Date

February 16, 2023

Last Update Submit

July 17, 2023

Conditions

CancerPainOpioid Analgesic Adverse Reaction

Outcome Measures

Primary Outcomes (2)

  • POMI scale score - Prescription Opioid Misuse Index

    8-item self-assessment scale

    day 1

  • POMI scale score - Prescription Opioid Misuse Index

    8-item self-assessment scale

    day 15

Secondary Outcomes (7)

  • QCD

    day 1

  • QCD

    day 15

  • Sociodemographic characteristics

    day 1

  • Lifestyle habits, other consumption

    day 1

  • Analgesic treatments

    day 1

  • +2 more secondary outcomes

Study Arms (1)

cancer patients

Questionnaires

Other: Questionnaires

Interventions

QuestionnairesOTHER

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.

cancer patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cancer patients

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU de Clermont-Ferrand

Clermont-Ferrand, France

RECRUITING

CH Le Puy en Velay

Le Puy-en-Velay, 43000, France

RECRUITING

MeSH Terms

Conditions

NeoplasmsPain

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Virginie Guastella

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

4 73 75 11 95promo_interne_drci@chu-clermontferrand.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2023

First Posted

March 9, 2023

Study Start

February 23, 2023

Primary Completion

April 1, 2024

Study Completion

April 1, 2025

Last Updated

July 18, 2023

Record last verified: 2023-02

Locations

FR(2)