Clinical Data Collection in Studying Clinical Factors Associated With Post-Surgery Chronic Opioid Use in Patients With Head and Neck Cancers
An Investigation of Postoperative Chronic Opioid Use and Its Associations With Other Clinical Factors Among Patients With Head and Neck Cancers
3 other identifiers
observational
125
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 16, 2019
CompletedStudy Start
First participant enrolled
January 25, 2019
CompletedFirst Posted
Study publicly available on registry
March 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2027
March 5, 2026
March 1, 2026
8.3 years
January 16, 2019
March 3, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (6)
Risk of opioid use assessed
Up to 90 days after surgery
Frequency of positive risk of opioid use disorder
Up to 90 days post surgery
Frequency of aberrant opioid use behaviors
Up to 90 days post surgery
Frequency of post-operative complications
Up to 90 days post surgery
Risk of opioid use will be assessed by CAGE-AID
Up to 90 days post surgery
- +1 more secondary outcomes
Study Arms (1)
Observational (questionnaires, 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.
Interventions
Complete quality of life assessment
Complete questionnaire
Eligibility Criteria
MD Anderson Cancer Participants
You may qualify if:
- 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
You may not qualify if:
- Patient not willing to participate
- Not competent to give informed consent
- Inability to read and write in English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Lakshmi Koyyalagunta
M.D. Anderson Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2019
First Posted
March 25, 2019
Study Start
January 25, 2019
Primary Completion (Estimated)
April 30, 2027
Study Completion (Estimated)
April 30, 2027
Last Updated
March 5, 2026
Record last verified: 2026-03