Opioid Misuse in Patients with Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cancer, Opioid Use, Opioid Misuse, Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prevalence of Opioid Misuse in Patients with Cancer
Overview
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:
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).
Primary outcome measures
- Pain Medication Questionnaire (PMQ) [Time frame: Baseline]
- Opioid Risk Tool (ORT) [Time frame: Baseline]
Secondary outcome measures (12)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Denmark · 1 center
- Rigshospitalet — Copenhagen
Identifiers
NCT: NCT06489769 · 100845