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

Head and Neck Carcinoma Clinical Trial

Official title:

An Investigation of Postoperative Chronic Opioid Use and Its Associations With Other Clinical Factors Among Patients With Head and Neck Cancers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03888651
• Other study ID #: 2018-0740
• Secondary ID: NCI-2018-0335720
• Status: Active, not recruiting
• Start date: January 25, 2019
• Est. completion date: April 30, 2025

Study information

• Verified date: April 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Carcinoma
• Head and Neck Neoplasms

Intervention

Other:
• Quality-of-Life Assessment
Complete quality of life assessment
• Questionnaire Administration
Complete questionnaire

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Severity of symptom burden	Will be measured by MDASI.	At 90 days after surgery
Primary	Association of chronic opioid use	Association of chronic opioid use with that of the CAGE-AID scores	At 90 days after surgery
Secondary	Risk of opioid use assessed	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.	Up to 90 days after surgery
Secondary	Frequency of positive risk of opioid use disorder	Will be assessed by Screener and Opioid Assessment for Patients with Pain[SOAPP-14.	Up to 90 days post surgery
Secondary	Frequency of aberrant opioid use behaviors	Correlation between categorical variables will be evaluated using Chisquare test or Fisher's exact test.	Up to 90 days post surgery
Secondary	Frequency of post-operative complications	Correlation between categorical variables will be evaluated using Chisquare test or Fisher's exact test	Up to 90 days post surgery
Secondary	Risk of opioid use will be assessed by CAGE-AID	CAGE-AID: Score of greater than or equal 2 is considered as risk factor for opioid misuse	Up to 90 days post surgery
Secondary	Frequency of positive risk of opioid use disorder	Will be assessed by CAGE-adapted to include drugs (AID).	Up to 90 days post surgery

External Links

•   MD Anderson Cancer Center Website