Head and Neck Carcinoma
Conditions
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.
Interventions
OTHERQuality-of-Life Assessment
Complete quality of life assessment
OTHERQuestionnaire Administration
Complete questionnaire
Sponsors
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Association of chronic opioid use | At 90 days after surgery | Association of chronic opioid use with that of the CAGE-AID scores |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 Screener and Opioid Assessment for Patients with Pain\[SOAPP-14. |
| 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 |
| 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLakshmi Koyyalagunta
M.D. Anderson Cancer Center
Outcome results
None listed