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

Active, not recruiting
Conditions
Head and Neck Carcinoma
Interventions
Other: Quality-of-Life Assessment
Other: 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
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
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Exclusion Criteria
  • Patient not willing to participate
  • Not competent to give informed consent
  • Inability to read and write in English
Read More

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Observational (questionnaires, quality of life assessment)Questionnaire AdministrationPatients 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 AssessmentPatients 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
NameTimeMethod
Association of chronic opioid useAt 90 days after surgery

Association of chronic opioid use with that of the CAGE-AID scores

Rate of chronic opioid useAt 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 burdenAt 90 days after surgery

Will be measured by MDASI.

Secondary Outcome Measures
NameTimeMethod
Risk of opioid use will be assessed by CAGE-AIDUp 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 assessedUp 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 disorderUp to 90 days post surgery

Will be assessed by CAGE-adapted to include drugs (AID).

Frequency of aberrant opioid use behaviorsUp to 90 days post surgery

Correlation between categorical variables will be evaluated using Chisquare test or Fisher's exact test.

Frequency of post-operative complicationsUp 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

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