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NCT Number: NCT03888651

Clinical Data Collection in Studying Clinical Factors Associated With Post-Surgery Chronic Opioid Use in 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Head and Neck Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quality-of-Life Assessment

Other

Complete quality of life assessment

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Complete questionnaire

Primary outcomes

  1. Rate of chronic opioid use

    Time frame: At 90 days after surgery

    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)

  2. Severity of symptom burden

    Time frame: At 90 days after surgery

    Will be measured by MDASI.

  3. Association of chronic opioid use

    Time frame: At 90 days after surgery

    Association of chronic opioid use with that of the CAGE-AID scores

Secondary outcomes

  1. Risk of opioid use assessed

    Time frame: Up to 90 days after surgery

    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.

  2. Frequency of positive risk of opioid use disorder

    Time frame: Up to 90 days post surgery

    Will be assessed by Screener and Opioid Assessment for Patients with Pain[SOAPP-14.

  3. Frequency of aberrant opioid use behaviors

    Time frame: Up to 90 days post surgery

    Correlation between categorical variables will be evaluated using Chisquare test or Fisher's exact test.

  4. Frequency of post-operative complications

    Time frame: Up to 90 days post surgery

    Correlation between categorical variables will be evaluated using Chisquare test or Fisher's exact test

  5. Risk of opioid use will be assessed by CAGE-AID

    Time frame: Up to 90 days post surgery

    CAGE-AID: Score of greater than or equal 2 is considered as risk factor for opioid misuse

  6. Frequency of positive risk of opioid use disorder

    Time frame: Up to 90 days post surgery

    Will be assessed by CAGE-adapted to include drugs (AID).

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Mar 25, 2019
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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