UnknownNot Applicable

Validation of a Screening Scale for Misuse of Opioid Analgesics

France150 participantsStarted 2023-02-23

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

POMI scale score - Prescription Opioid Misuse Index

Timeframe: day 1

POMI scale score - Prescription Opioid Misuse Index

Timeframe: day 15

Trial details

NCT IDNCT05761587

SponsorUniversity Hospital, Clermont-Ferrand

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-04-01

Contact for this trial

Lise Laclautre

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

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