Clinical trial NCT03888651: Clinical Data Collection in Studying Clinical Factors Associated With Post-Surgery Chronic Opioid Use in Patients With Head and Neck Cancers
Official title: An Investigation of Postoperative Chronic Opioid Use and Its Associations With Other Clinical Factors Among Patients With Head and Neck Cancers
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Head and Neck Carcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-03-25
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MD Anderson Cancer Participants

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of chronic opioid use
timeFrame: At 90 days after surgery
measure: Severity of symptom burden
timeFrame: At 90 days after surgery
measure: Association of chronic opioid use
timeFrame: At 90 days after surgery
Secondary outcomes:
measure: Risk of opioid use assessed
timeFrame: Up to 90 days after surgery
measure: Frequency of positive risk of opioid use disorder
timeFrame: Up to 90 days post surgery
measure: Frequency of aberrant opioid use behaviors
timeFrame: Up to 90 days post surgery
measure: Frequency of post-operative complications
timeFrame: Up to 90 days post surgery
measure: Risk of opioid use will be assessed by CAGE-AID
timeFrame: Up to 90 days post surgery
measure: Frequency of positive risk of opioid use disorder
timeFrame: Up to 90 days post surgery
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Lakshmi Koyyalagunta
role: PRINCIPAL_INVESTIGATOR
References: