Opioid Misuse in Patients with Cancer

NCT06489769 | Recruiting

• 1 other identifier: 100845
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Opioid Use; Opioid Misuse; Pain; Cancer Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• Pain diagnosis

  Baseline

• Pain duration

  Baseline

• Pain localization

  Baseline

• Pain intensity

  Baseline

• Opioids

  Baseline

Other Outcomes (7)

• Sex

  Baseline

• Age

  Baseline

• Marital status

  Baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, København Ø., 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Neoplasms; Opioid-Related Disorders; Pain; Cancer Pain

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Geana Kurita, PHD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Geana Kurita, Professor

CONTACT

+4535454797; geana.kurita@regionh.dk

Camilla Lykke, Post. doc

CONTACT

+4523820143; camilla.charlotte.lykke.01@regionh.dk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 8, 2024
• Study Start: January 15, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)