Clinical Data Collection in Studying Clinical Factors Associated With Post-Surgery Chronic Opioid Use in Patients With Head and Neck Cancers
- Conditions
- Head and Neck Carcinoma
- Interventions
- Other: Quality-of-Life AssessmentOther: Questionnaire Administration
- Registration Number
- NCT03888651
- Lead Sponsor
- M.D. Anderson Cancer Center
- Brief 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 125
- 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
- Patient not willing to participate
- Not competent to give informed consent
- Inability to read and write in English
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Observational (questionnaires, quality of life assessment) Questionnaire Administration 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. Observational (questionnaires, quality of life assessment) Quality-of-Life Assessment 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.
- Primary Outcome Measures
Name Time Method Association of chronic opioid use At 90 days after surgery Association of chronic opioid use with that of the CAGE-AID scores
Rate of chronic opioid use At 90 days after surgery 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)
Severity of symptom burden At 90 days after surgery Will be measured by MDASI.
- Secondary Outcome Measures
Name Time Method Risk of opioid use will be assessed by CAGE-AID Up to 90 days post surgery CAGE-AID: Score of greater than or equal 2 is considered as risk factor for opioid misuse
Risk of opioid use assessed Up to 90 days after surgery 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.
Frequency of positive risk of opioid use disorder Up to 90 days post surgery Will be assessed by CAGE-adapted to include drugs (AID).
Frequency of aberrant opioid use behaviors Up to 90 days post surgery Correlation between categorical variables will be evaluated using Chisquare test or Fisher's exact test.
Frequency of post-operative complications Up to 90 days post surgery Correlation between categorical variables will be evaluated using Chisquare test or Fisher's exact test
Trial Locations
- Locations (1)
M D Anderson Cancer Center
🇺🇸Houston, Texas, United States