CancerVPOMIONCOLNCT05761587
Validation of a Screening Scale for Misuse of Opioid Analgesics
An observational study of Cancer and Pain, run by University Hospital, Clermont-Ferrand at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Pain, Opioid Analgesic Adverse Reaction
- What is being tested?
- Questionnaires
- How many people
- 150 participants
- Where
- 2 sitesFrance
- Study dates
- 23 Feb 2023to 1 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cancer patients
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand
Lise Laclautre
Virginie Guastella
- Recruiting
CH Le Puy en Velay
Le Puy-en-Velay, 43000
Brigitte MONANGE
About this study
Official title: Validation of a Screening Scale for the Misuse of Opioid Analgesics in Patients With Chronic Pain Related to Cancer.
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).
Read the 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.
- Conditions
- Cancer, Pain, Opioid Analgesic Adverse Reaction
- Being tested
- Questionnaires
- Medical subject headings
- Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| cancer patients | Questionnaires Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
POMI scale score - Prescription Opioid Misuse Index
8-item self-assessment scale
Measured: day 1
POMI scale score - Prescription Opioid Misuse Index
8-item self-assessment scale
Measured: day 15
Secondary outcomes (7)
QCD
Visual Analogue Scales (VAS) for assessing the intensity and daily impact of pain (0-10)
Measured: day 1
QCD
Visual Analogue Scales (VAS) for assessing the intensity and daily impact of pain (0-10)
Measured: day 15
Sociodemographic characteristics
Questionnaire about Sociodemographic characteristics of patients
Measured: day 1
Lifestyle habits, other consumption
Questionnaire about Lifestyle habits, other consumption
Measured: day 1
Analgesic treatments
Questionnaire about Ongoing analgesic treatments
Measured: day 1
Use of analgesics
Question evaluating the use of analgesics in the context of anticipating pain
Measured: day 1
Use of analgesics
Question evaluating the use of analgesics in the context of anticipating pain
Measured: day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start23 Feb 2023
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Virginie Guastella, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05761587
- Sponsor's protocol ID
- RNI 2022 GUASTELLA
- Acronym
- VPOMIONCOL
- Status last verified
- Feb 2023
- First submitted
- 16 Feb 2023
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Screening Scale for the Misuse of Opioid Analgesics in Patients With Chronic Pain Related to Cancer.
- ClinicalTrials.gov ID
- NCT05761587
- Acronym / sponsor ID
- VPOMIONCOL / RNI 2022 GUASTELLA
- Conditions
- Cancer, Pain, Opioid Analgesic Adverse Reaction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 23 Feb 2023 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 9 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cancer patients | – | Other: QuestionnairesQuestionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer patients
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnairesquestionnaire 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. | Other | cancer patients |
Primary outcome
POMI scale score - Prescription Opioid Misuse Index
Time frame: day 1
8-item self-assessment scale
POMI scale score - Prescription Opioid Misuse Index
Time frame: day 15
8-item self-assessment scale
7 secondary outcomes
QCD
Time frame: day 1
QCD
Time frame: day 15
Sociodemographic characteristics
Time frame: day 1
Lifestyle habits, other consumption
Time frame: day 1
Analgesic treatments
Time frame: day 1
Use of analgesics
Time frame: day 1
Use of analgesics
Time frame: day 15
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Virginie Guastella principal investigator
University Hospital, Clermont-Ferrand
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Pain, run by University Hospital, Clermont-Ferrand at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (4 73 75 11 95 ext. +33, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
POMI scale score - Prescription Opioid Misuse Index (time frame: day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2023.