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

M.D. Anderson Cancer Center

Status: Active, not recruiting

Conditions: Head and Neck Carcinoma

Treatments: Other: Questionnaire Administration; Other: Quality-of-Life Assessment

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03888651

P30CA016672 (U.S. NIH Grant/Contract)

NCI-2018-03357 (Registry Identifier)

2018-0740 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 125 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

125 participants in 1 patient group

Observational (questionnaires, quality of life assessment)

Description:

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.

Treatment:

Other: Quality-of-Life Assessment

Other: Questionnaire Administration