Rigshospitalet
Copenhagen, København Ø., 2100, Denmark
Location status: Recruiting
NCT Number: NCT06489769
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Copenhagen, København Ø., 2100, Denmark
Location status: Recruiting
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Baseline
Categories: nociceptive somatic, nociceptive visceral, neuropathic, nociplastic, nociceptive +somatic (mixed).
Time frame: Baseline
In months.
Time frame: Baseline
Categories: head/face/mouth/neck, up limbs, lower limbs, thorax, abdomen, low back/gluteus/coccyx/pelvis.
Time frame: Baseline
Numerical scale from 0 (no pain) to 10 (worst pain).
Time frame: Baseline
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.
Time frame: Baseline
Patient consumption of benzodiazepines: Name, dose and duration of treatment will be recorded. Data will be collected from patients electronic records.
Time frame: Baseline
Patient consumption of Hypnotics: Name, dose and duration of treatment will be recorded. Data will be collected from patients electronic records.
Time frame: Baseline
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''.
Time frame: Baseline
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
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: 1 month after baseline
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.'
Time frame: Baseline
Categories male, female.
Time frame: Baseline
Complete years in number.
Time frame: Baseline
Categories; single (unmarried), married, cohabitating, separated/divorced, widow/widower.
Time frame: Baseline
Categories, basic school, upper secondary or vocational school, higher education.
Time frame: Baseline
Number of years of formal education.
Time frame: Baseline
Categories in Danish Krone (DKK): <200.000 DKK, 200.000-500.000 DKK, >500.000 DKK
Time frame: Baseline
Categories: working/studying, retired, on sick leave.
Contact information is provided by the study sponsor or research team.
Camilla Lykke, Post. doc
CONTACT
Geana Kurita, Professor
CONTACT
Rigshospitalet, Denmark
Other
Prevalence of Opioid Misuse in Patients with Cancer
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07318519
Cancer, Cancer Pain
Washington D.C., District of Columbia, United States
View Trial DetailsNCT05051735
Cancer, Cancer Pain
Milan, Italy
View Trial DetailsNCT07262151
Anxiety, Anxiety Disorders
Yozgat, Merkez, Turkey (Türkiye)
View Trial DetailsNCT06590389
Anxiety Disorders, Cancer
Istanbul, Üsküdar, Turkey (Türkiye)
View Trial Details