NCT03888651

Clinical Data Collection in Studying Clinical Factors Associated With Post-Surgery Chronic Opioid Use in Patients With Head and Neck Cancers

An Investigation of Postoperative Chronic Opioid Use and Its Associations With Other Clinical Factors Among Patients With Head and Neck Cancers

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 125 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial studies the risk of developing disorders associated with chronic opioid use post-surgery in patients with head and neck cancers. Clinical data collection may help doctors to learn how often and how likely disorders associated with the use of opioid pain medication may occur in patients with head and neck cancer who are having surgery as part of their treatment plan.

Detailed description

PRIMARY OBJECTIVES: I. Assess prevalence of chronic opioid use and severity of symptom burden (M. D. Anderson Symptom Inventory-Head and Neck \[MDASI-HN\]) in patients undergoing surgery of head/neck cancer. SECONDARY OBJECTIVES: I. To investigate the extent of association of chronic opioid use with risk of opioid use disorder (as assessed by Screener and Opioid Assessment for Patients with Pain\[SOAPP-14\] and Cut down, Annoyed, Guilty and Eye Opener \[CAGE\] scores) and psychosocial factors (as assessed by MDASI). II. To assess frequency of positive risk of opioid use disorder as assessed by Screener and Opioid Assessment for Patients tool (SOAPP-14) and CAGE-adapted to include drugs (AID). III. Assess frequency of aberrant opioid use behaviors. IV. Assess frequency of post-operative complications. OUTLINE: Patients complete questionnaires and quality of life assessments over 10-15 minutes at pre-surgery, after-surgery, at discharge, within 2-3 weeks after surgery, and within 90 days after surgery.

Conditions

• Head and Neck Carcinoma

Interventions

Type	Name	Description
OTHER	Quality-of-Life Assessment	Complete quality of life assessment
OTHER	Questionnaire Administration	Complete questionnaire

Timeline

• Start date: 2019-01-25
• Primary completion: 2027-04-30
• Completion: 2027-04-30
• First posted: 2019-03-25
• Last updated: 2026-03-05

Locations

1 site across 1 country: United States