An observational study in Head and Neck Carcinoma, sponsored by M.D. Anderson Cancer Center. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by M.D. Anderson Cancer Center · Observational
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.
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.
M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
MD Anderson Cancer Participants
Exclusion Criteria:
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.
Other: Quality-of-Life Assessment · Other: Questionnaire Administration
Complete quality of life assessment
Also known as: Quality of Life Assessment
Complete questionnaire
Rate of chronic opioid use
Rate of chronic opioid use will be measured by the association of chronic opioid use with that of the risk of opioid misuse Screener and Opioid Assessment for Patients tool (SOAPP-14)
Time frame: At 90 days after surgery
Severity of symptom burden
Will be measured by MDASI.
Time frame: At 90 days after surgery
Association of chronic opioid use
Association of chronic opioid use with that of the CAGE-AID scores
Time frame: At 90 days after surgery
Risk of opioid use assessed
Screener and Opioid Assessment for Patients with Pain\[SOAPP-14\] Score of greater than or equal 7 is considered as risk factor for opioid misuse.
Time frame: Up to 90 days after surgery
Frequency of positive risk of opioid use disorder
Will be assessed by Screener and Opioid Assessment for Patients with Pain\[SOAPP-14.
Time frame: Up to 90 days post surgery
Frequency of aberrant opioid use behaviors
Correlation between categorical variables will be evaluated using Chisquare test or Fisher's exact test.
Time frame: Up to 90 days post surgery
Frequency of post-operative complications
Correlation between categorical variables will be evaluated using Chisquare test or Fisher's exact test
Time frame: Up to 90 days post surgery
Risk of opioid use will be assessed by CAGE-AID
CAGE-AID: Score of greater than or equal 2 is considered as risk factor for opioid misuse
Time frame: Up to 90 days post surgery
Frequency of positive risk of opioid use disorder
Will be assessed by CAGE-adapted to include drugs (AID).
Time frame: Up to 90 days post surgery
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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M.D. Anderson Cancer Center