Validation of a Screening Scale for Misuse of Opioid Anal... | NCT05761587

Studies
Validation of a Screening Scale for Misuse of Opioid Analgesics

NCT05761587

Sponsor

University Hospital, Clermont-Ferrand

Status

Unknown status

Last Update Posted

Jul 18, 2023Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Cancer
Pain
Opioid Analgesic Adverse Reaction

Interventions

Questionnaires

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 23, 2023Actual

Primary Completion Date

Apr 1, 2024Estimated

Completion Date

Apr 1, 2025Estimated

First Submitted Date

Feb 16, 2023

First Submission Date that Met QC Criteria

Feb 27, 2023

First Posted Date

Mar 9, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 17, 2023

Last Update Posted Date

Jul 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cancer patients		Questionnaires	Other: Questionnaires

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionnaires	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
QCD	Visual Analogue Scales (VAS) for assessing the intensity and daily impact of pain (0-10)	day 1
QCD	Visual Analogue Scales (VAS) for assessing the intensity and daily impact of pain (0-10)

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Cancer patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lise Laclautre	Contact	4 73 75 11 95	+33	promo_interne_drci@chu-clermontferrand.fr

Overall Officials

Name	Affiliation	Role
Virginie Guastella	University Hospital, Clermont-Ferrand	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Clermont-Ferrand	Recruiting	Clermont-Ferrand			France

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided