Opioid Misuse in Patients with Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Pain; Cancer; Opioid Use; Cancer Pain; Opioid Misuse
• Intervention / Treatment: Other: Qualitative question for physicians

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:

1. 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.
2. 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.
3. 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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Geana Kurita, Professor; Phone Number: +4535454797; Email: geana.kurita@regionh.dk
• Study Contact Backup: Name: Camilla Lykke, Post. doc; Phone Number: +4523820143; Email: camilla.charlotte.lykke.01@regionh.dk

Study Locations

• Denmark
  • København Ø.
    • København, København Ø., Denmark, 2100
      • Recruiting
      • Rigshospitalet
      • Contact: Geana Kurita, PHD.
      • Contact: Camilla Lykke, PHD; Email: camilla.charlotte.lykke.01@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• Outpatients ≥ 18 years,
• patients who are treated with opioids due to cancer-related pain.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patient sample; Adults outpatients who are treated with opioids due to cancer-related pain.

Other: Qualitative question for physicians; Opioid misuse can be defined 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). This includes opioid dependence, opioid abuse, opioid use disorder, opioid addiction, and aberrant opioid behaviour. After four weeks patient participation, the physician will be asked the question below, regarding the patients risk of misuse. In your clinical judgment, is the patient misusing opioids? Yes No Maybe I do not know

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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
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
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
Benzodiazepines	Patient consumption of benzodiazepines: Name, dose and duration of treatment will be recorded. Data will be collected from patients electronic records.	Baseline
Hypnotics	Patient consumption of Hypnotics: Name, dose and duration of treatment will be recorded. Data will be collected from patients electronic records.	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	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.	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.'	1 month after baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: North Zealand Hospital, Denmark
• Investigators: Principal Investigator: Geana Kurita, PhD, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: June 27, 2024
• First Submitted That Met QC Criteria: June 28, 2024
• First Posted (Actual): July 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 21, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Pain; Neurologic Manifestations; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Cancer Pain; Opioid-Related Disorders
• Other Study ID Numbers: 100845

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No