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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03888651
Study type Observational
Source M.D. Anderson Cancer Center
Contact
Status Active, not recruiting
Phase
Start date January 25, 2019
Completion date April 30, 2025

See also
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