Opioid Misuse in Patients With Cancer
NCT Number: NCT06489769
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cancer|Opioid Use|Opioid Misuse|Pain|Cancer Pain
Sponsor: Rigshospitalet, Denmark
Collaborators: North Zealand Hospital, Denmark
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-05-01
Locations: Rigshospitalet, København, København Ø., 2100, Denmark

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 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 in oncologic and palliative care units. 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 oncologic and palliative care units will be investigate.

Primary Outcome Measures: 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., 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., Baseline
Secondary Outcome Measures: Pain diagnosis, Categories: nociceptive somatic, nociceptive visceral, neuropathic, nociplastic, nociceptive +somatic (mixed)., Baseline|Pain duration, In months., Baseline|Pain localization, Categories: head/face/mouth/neck, up limbs, lower limbs, thorax, abdomen, low back/gluteus/coccyx/pelvis., Baseline|Pain intensity, Numerical scale from 0 (no pain) to 10 (worst pain)., 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., Baseline|Benzodiazepines, Patient consumption of benzodiazepines: Name, dose and duration of treatment is recorded. Data will be collected from patients electronic records., Baseline|Hypnotics, Patient consumption of Hypnotics: Name, dose and duration of treatment is recorded. Data will be collected from patients electronic records., 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''., Baseline|Tobacco, Tobacco use (number of cigarettes, cigars and/or pipe tobacco per day). Smoking behaviour was 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, 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., 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., Baseline|The patients' self-assessed health, To assess the patients' self-assessed health the following question was used: 'How is your health overall? ´ The respondents rated excellent, very good, good, less good or poor. The question has been used in previous large national surveys of the general population in Denmark., Baseline
Other Outcome Measures: Sex, Categories male, female., Baseline|Age, Complete years in number., Baseline|Marital status, Categories; single (unmarried), married, cohabitating, separated/divorced, widow/widower., Baseline|Education status, Categories, basic school, upper secondary or vocational school, higher education., Baseline|Schooling, Number of years of formal education., Baseline|Income, Categories in Danish Krone (DKK): \<200.000 DKK, 200.000-500.000 DKK, \>500.000 DKK, Baseline|Occupational status, Categories: working/studying, retired, on sick leave., Baseline