Clinical Data Collection in Studying Clinical Factors Associated With Post-Surgery Chronic Opioid Use in Patients With Head and Neck Cancers
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/27/2019 |
| Start Date: | January 25, 2019 |
| End Date: | December 31, 2019 |
| Contact: | Lakshmi Koyyalagunta |
| Email: | dkoyyala@mdanderson.org |
| Phone: | 713-745-4939 |
An Investigation of Postoperative Chronic Opioid Use and Its Associations With Other Clinical Factors Among Patients With Head and Neck Cancers
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.
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.
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.
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.
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
We found this trial at
1
site
Houston, Texas 77030
Principal Investigator: Lakshmi Koyyalagunta
Phone: 713-745-4939
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