Prevalence of Opioid Misuse in Patients With Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Suspended
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Opioid Risk Tool (ORT)
Study Overview
Brief 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. 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
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- Benzodiazepines(Baseline)
- Hypnotics(Baseline)
- Alcohol(Baseline)
- Tobacco(Baseline)
- Patient Health Questionnaire-4 (PHQ-4)(Baseline)
- The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 - Palliative Care (EORTC-QLQ-C15-PAL)(Baseline)
- The patients' self-assessed health(Baseline)
- Information provided by the physician regarding the patient's opioid misuse(1 month after baseline)
- Pain diagnosis(Baseline)
- Pain duration(Baseline)
- Pain localization(Baseline)
- Pain intensity(Baseline)
- Opioids(Baseline)
Investigators
Geana P Kurita
Professor
Rigshospitalet, Denmark