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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
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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