Ignite Creation Date:
2024-07-17 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06489769
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-06-27
Brief Title:
Opioid Misuse in Patients With Cancer
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Prevalence of Opioid Misuse in Patients With Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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 eg for other purpose than pain relief in greater amounts more frequently longer using someone elses 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 oncologic and 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 andor consumption of benzodiazepines and benzodiazepine-like hypnotics
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
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 oncologic and 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 andor consumption of benzodiazepines and benzodiazepine-like hypnotics
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None