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

Primary Purpose

Head and Neck Carcinoma

Status
Active
Phase
Locations
United States
Study Type
Observational
Intervention
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Head and Neck Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Arm Label

Observational (questionnaires, quality of life assessment)

Arm 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.

Outcomes

Primary Outcome Measures

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)
Severity of symptom burden
Will be measured by MDASI.
Association of chronic opioid use
Association of chronic opioid use with that of the CAGE-AID scores

Secondary Outcome Measures

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.
Frequency of positive risk of opioid use disorder
Will be assessed by Screener and Opioid Assessment for Patients with Pain[SOAPP-14.
Frequency of aberrant opioid use behaviors
Correlation between categorical variables will be evaluated using Chisquare test or Fisher's exact test.
Frequency of post-operative complications
Correlation between categorical variables will be evaluated using Chisquare test or Fisher's exact test
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
Frequency of positive risk of opioid use disorder
Will be assessed by CAGE-adapted to include drugs (AID).

Full Information

First Posted
January 16, 2019
Last Updated
September 27, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03888651
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 25, 2019 (Actual)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Carcinoma

7. Study Design

Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Observational (questionnaires, quality of life assessment)
Arm 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.
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Complete quality of life assessment
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Complete questionnaire
Primary Outcome Measure Information:
Title
Rate of chronic opioid use
Description
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)
Time Frame
At 90 days after surgery
Title
Severity of symptom burden
Description
Will be measured by MDASI.
Time Frame
At 90 days after surgery
Title
Association of chronic opioid use
Description
Association of chronic opioid use with that of the CAGE-AID scores
Time Frame
At 90 days after surgery
Secondary Outcome Measure Information:
Title
Risk of opioid use assessed
Description
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.
Time Frame
Up to 90 days after surgery
Title
Frequency of positive risk of opioid use disorder
Description
Will be assessed by Screener and Opioid Assessment for Patients with Pain[SOAPP-14.
Time Frame
Up to 90 days post surgery
Title
Frequency of aberrant opioid use behaviors
Description
Correlation between categorical variables will be evaluated using Chisquare test or Fisher's exact test.
Time Frame
Up to 90 days post surgery
Title
Frequency of post-operative complications
Description
Correlation between categorical variables will be evaluated using Chisquare test or Fisher's exact test
Time Frame
Up to 90 days post surgery
Title
Risk of opioid use will be assessed by CAGE-AID
Description
CAGE-AID: Score of greater than or equal 2 is considered as risk factor for opioid misuse
Time Frame
Up to 90 days post surgery
Title
Frequency of positive risk of opioid use disorder
Description
Will be assessed by CAGE-adapted to include drugs (AID).
Time Frame
Up to 90 days post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Study Population Description
MD Anderson Cancer Participants
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lakshmi Koyyalagunta
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center Website

Learn more about this trial

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

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