CancerNCT06489769
Opioid Misuse in Patients With Cancer
An observational study of Cancer and Opioid Use, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The success of opioid treatment in terminally ill cancer patients set the stage for extending the same treatment principles to the treatment of all chronic pain conditions including chronic non-cancer pain and chronic pain in cancer, where survival and long-standing chronic disease trajectories are getting more… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Opioid Use, Opioid Misuse
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Jan 2025to 31 Dec 2026
- 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: Patients will be recruited from Section of Palliative Medicine at Rigshospitalet. Patients can participate if ≥ 18 years and able to communicate in Danish.
Who may be able to join
- Outpatients ≥ 18 years,
- patients who are treated with opioids due to cancer-related pain.
Who cannot join
- Patients who do not master the Danish language in speech and writing,
- Patients who have severe cognitive dysfunction,
- Patients who are not treated with opioids,
- Patients who refused to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Opioid Misuse in Patients With Cancer
The success of opioid treatment in terminally ill cancer patients set the stage for extending the same treatment principles to the treatment of all chronic pain conditions including chronic non-cancer pain and chronic pain in cancer, where survival and long-standing chronic disease trajectories are getting more prevalent due to increasing survival rates. In this context, opioid misuse as such has been highly neglected - especially in palliative care, but also in cancer pain management in general. Previous studies have explored the literature on opioid misuse among adult cancer patients, noting that the available evidence is still in its early stages. Limited prospective studies with a wide range of definitions and methodologies for assessing misuse exist. Therefore, it seems highly relevant and justified to study the prevalence of opioid misuse risk in patients with cancer. The hypothesis of this study is that opioid misuse is not uncommon in Danish patients in treatment with opioids for cancer-related pain. Thus, the prevalence of opioid misuse risk among patients with cancer in Danish palliative care units will be investigate.
Read the detailed description
This is a prospective and cross-sectional study, in which opioid misuse is defined according to National Institute on Drug Abuse (USA) as the use of prescription opioids in a manner other than as directed by a doctor (e.g., for other purpose than pain relief, in greater amounts, more frequently, longer, using someone else's prescription). The aims are:
- Investigate the prevalence of opioid misuse risk by the Pain Medication Questionnaire (PMQ) and the Opioid Risk Tool (ORT) among patients with cancer in palliative care units in Denmark.
- Determine whether there is a correlation between the PMQ and ORT scores and opioid consumption, use of short-acting opioids (prn-dosing), tobacco smoking, alcohol consumption, previous consumption of illicit drugs and/or consumption of benzodiazepines and benzodiazepine-like hypnotics, and information provided by the physician regarding the patient's opioid misuse.
- Investigate the association between opioid misuse risk (PMQ and ORT scores), depression and anxiety (Patient Health Questionnaire for Depression and Anxiety, PHQ-4), and health-related quality of life (EORTC-QLQ-C15-PAL).
- Conditions
- Cancer, Opioid Use, Opioid Misuse, Pain, Cancer Pain
- Medical subject headings
- Neoplasms, Opioid-Related Disorders, Pain, Cancer Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Medication Questionnaire (PMQ)
PMQ consists of 26 questions assesses the risk of opioid abuse in people with non-oncological chronic pain. The answers are given on a 5-point Likert scale. Total score varies between 0 and 104 points.
Measured: Baseline
Opioid Risk Tool (ORT)
ORT consists of a 5-question screening instrument assessing the risk for opioid abuse among individuals prescribed opioids for treatment of chronic pain.
Measured: Baseline
Secondary outcomes (13)
Pain diagnosis
Categories: nociceptive somatic, nociceptive visceral, neuropathic, nociplastic, nociceptive +somatic (mixed).
Measured: Baseline
Pain duration
In months.
Measured: Baseline
Pain localization
Categories: head/face/mouth/neck, up limbs, lower limbs, thorax, abdomen, low back/gluteus/coccyx/pelvis.
Measured: Baseline
Pain intensity
Numerical scale from 0 (no pain) to 10 (worst pain).
Measured: Baseline
Opioids
Patient consumption of opioids. Name, dose and duration of treatment will be recorded. When treated with opioids, doses are converted to oral morphine equivalents. Data will be collected from patients electronic records.
Measured: Baseline
Benzodiazepines
Patient consumption of benzodiazepines: Name, dose and duration of treatment will be recorded. Data will be collected from patients electronic records.
Measured: Baseline
Hypnotics
Patient consumption of Hypnotics: Name, dose and duration of treatment will be recorded. Data will be collected from patients electronic records.
Measured: Baseline
Alcohol
Alcohol consumption (number of drinks per week). The following question will be used to assess the amount of alcohol intake: ''How many alcoholic drink glasses did you have each day last week? We'll start with yesterday and take one day at a time''.
Measured: Baseline
Tobacco
Tobacco use (number of cigarettes, cigars and/or pipe tobacco per day). Smoking behaviour will be assessed by asking the respondent whether they smoked or not, and smokers were asked about their average daily number of smoked cigarettes. Heavy smokers were defined as individuals smoking at least 15 cigarettes a day
Measured: Baseline
Patient Health Questionnaire-4 (PHQ-4)
The validated two-item ultra-brief screeners for depression (PHQ-2) and anxiety (GAD-2) were combined to constitute the PHQ-4. PHQ-4 is a reliable and valid instrument for screening depressive and anxiety symptoms, both for the clinical and nonclinical populations. Total score is determined by adding together the scores of each of the 4 items. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12). Total score ≥3 for first 2 questions suggests anxiety. Total score ≥3 for last 2 questions suggests depression.
Measured: Baseline
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 - Palliative Care (EORTC-QLQ-C15-PAL)
The EORTC-QLQ-C15-PAL is a 'core questionnaire' for use in palliative care and focuses on frequent symptoms, emotional and physical function, and global health status/ quality of life. It includes 15 items with two multi- item functional scales (physical and emotional functioning), two multi-item symptom scales (fatigue and pain) and a five single item symptom scale (dyspnoea, appetite loss, nausea and vomiting, insomnia, and constipation). One item addresses the global health status/ quality of life. The responses are on a 1-4-point Likert scale for all items ranging from 1 (not at all) to 4 (very much), except for one item measuring global health status/quality of life ranging from 1 (very poor) to 7 (excellent). For functioning scales, 100 represents good functioning with no problems. For symptom scales, 100 represents a high degree of symptom burden.
Measured: Baseline
The patients' self-assessed health
To assess the patients' self-assessed health the following question will be used: 'How is your health overall? ´ The respondents rate excellent, very good, good, less good or poor. The question has been used in previous large national surveys of the general population in Denmark.
Measured: Baseline
Information provided by the physician regarding the patient's opioid misuse
The physician treating the patient at the palliative care unit will be asked regarding the patient's potential opioid misuse. The physician will receive written information outlining the operational definition of opioid misuse applied in this study, followed by a closed question: 'In your clinical evaluation, is the patient (identification information: name) an opioid misuser?' The response options are 'Yes,' 'No,' 'Maybe,' and 'I do not know.'
Measured: 1 month after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start15 Jan 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Why it stopped: Enrollment suspended due to insufficient recruitment resulting from staffing shortages and organizational changes at the study site.
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 Copenhagen University Hospital, RigshospitaletThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geana P Kurita, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Geana Kurita, PHD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06489769
- Sponsor's protocol ID
- 100845
- Status last verified
- Aug 2026
- First submitted
- 27 Jun 2024
- Last updated
- 12 Aug 2026
- 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 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Opioid Misuse in Patients With Cancer
- ClinicalTrials.gov ID
- NCT06489769
- Acronym / sponsor ID
- 100845
- Conditions
- Cancer, Opioid Use, Opioid Misuse, Pain, Cancer Pain
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Enrollment suspended due to insufficient recruitment resulting from staffing shortages and organizational changes at the study site.
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Jul 2024 (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.
The success of opioid treatment in terminally ill cancer patients set the stage for extending the same treatment principles to the treatment of all chronic pain conditions including chronic non-cancer pain and chronic pain in cancer, where survival and long-standing chronic disease trajectories are getting more prevalent due to increasing survival rates. In this context, opioid misuse as such has been highly neglected - especially in palliative care, but also in cancer pain management in general. Previous studies have explored the literature on opioid misuse among adult cancer patients, noting that the available evidence is still in its early stages. Limited prospective studies with a wide range of definitions and methodologies for assessing misuse exist. Therefore, it seems highly relevant and justified to study the prevalence of opioid misuse risk in patients with cancer. The hypothesis of this study is that opioid misuse is not uncommon in Danish patients in treatment with opioids for cancer-related pain. Thus, the prevalence of opioid misuse risk among patients with cancer in Danish palliative care units will be investigate.
Detailed description
This is a prospective and cross-sectional study, in which opioid misuse is defined according to National Institute on Drug Abuse (USA) as the use of prescription opioids in a manner other than as directed by a doctor (e.g., for other purpose than pain relief, in greater amounts, more frequently, longer, using someone else's prescription). The aims are:
- Investigate the prevalence of opioid misuse risk by the Pain Medication Questionnaire (PMQ) and the Opioid Risk Tool (ORT) among patients with cancer in palliative care units in Denmark.
- Determine whether there is a correlation between the PMQ and ORT scores and opioid consumption, use of short-acting opioids (prn-dosing), tobacco smoking, alcohol consumption, previous consumption of illicit drugs and/or consumption of benzodiazepines and benzodiazepine-like hypnotics, and information provided by the physician regarding the patient's opioid misuse.
- Investigate the association between opioid misuse risk (PMQ and ORT scores), depression and anxiety (Patient Health Questionnaire for Depression and Anxiety, PHQ-4), and health-related quality of life (EORTC-QLQ-C15-PAL).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from Section of Palliative Medicine at Rigshospitalet. Patients can participate if ≥ 18 years and able to communicate in Danish.
Key inclusion criteria (2 listed)
- Outpatients ≥ 18 years,
- patients who are treated with opioids due to cancer-related pain.
Key exclusion criteria (4 listed)
- Patients who do not master the Danish language in speech and writing,
- Patients who have severe cognitive dysfunction,
- Patients who are not treated with opioids,
- Patients who refused to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain Medication Questionnaire (PMQ)
Time frame: Baseline
PMQ consists of 26 questions assesses the risk of opioid abuse in people with non-oncological chronic pain. The answers are given on a 5-point Likert scale. Total score varies between 0 and 104 points.
Opioid Risk Tool (ORT)
Time frame: Baseline
ORT consists of a 5-question screening instrument assessing the risk for opioid abuse among individuals prescribed opioids for treatment of chronic pain.
13 secondary outcomes
Pain diagnosis
Time frame: Baseline
Pain duration
Time frame: Baseline
Pain localization
Time frame: Baseline
Pain intensity
Time frame: Baseline
Opioids
Time frame: Baseline
Benzodiazepines
Time frame: Baseline
Hypnotics
Time frame: Baseline
Alcohol
Time frame: Baseline
Tobacco
Time frame: Baseline
Patient Health Questionnaire-4 (PHQ-4)
Time frame: Baseline
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 - Palliative Care (EORTC-QLQ-C15-PAL)
Time frame: Baseline
The patients' self-assessed health
Time frame: Baseline
Information provided by the physician regarding the patient's opioid misuse
Time frame: 1 month after baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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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.
Geana Kurita, PHD principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site 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 Opioid Use, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 2 inclusion and 4 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: paused, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Medication Questionnaire (PMQ) (time frame: Baseline). 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 12 Aug 2026.