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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Head and Neck Carcinoma

Intervention / Treatment
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* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with head and neck cancer scheduled for combined head and neck surgery - plastic surgery free flap Competent to give informed consent Ability to read and write in English Exclusion Criteria: Patient not willing to participate Not competent to give informed consent Inability to read and write in English

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (questionnaires, quality of life assessment)<br>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<br>* Complete quality of life assessment<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Complete questionnaire<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | At 90 days after surgery | 
| Severity of symptom burden | Will be measured by MDASI. | At 90 days after surgery | 
| Association of chronic opioid use | Association of chronic opioid use with that of the CAGE-AID scores | At 90 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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 | 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 | Up to 90 days post surgery | 
| Frequency of positive risk of opioid use disorder | Will be assessed by CAGE-adapted to include drugs (AID). | Up to 90 days post surgery |