An Investigation of Postoperative Chronic Opioid Use and Its Associations With Other Clinical Factors Among Patients With Head and Neck Cancers
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Association of chronic opioid use
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patient not willing to participate
- •Not competent to give informed consent
- •Inability to read and write in English
研究组 & 干预措施
Observational (questionnaires, quality of life assessment)
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.
干预措施: Questionnaire Administration (Other)
Observational (questionnaires, quality of life assessment)
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.
干预措施: Quality-of-Life Assessment (Other)
结局指标
主要结局
Association of chronic opioid use
时间窗: At 90 days after surgery
Association of chronic opioid use with that of the CAGE-AID scores
Rate of chronic opioid use
时间窗: 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)
Severity of symptom burden
时间窗: At 90 days after surgery
Will be measured by MDASI.
次要结局
- Risk of opioid use will be assessed by CAGE-AID(Up to 90 days post surgery)
- Frequency of post-operative complications(Up to 90 days post surgery)
- Risk of opioid use assessed(Up to 90 days after surgery)
- Frequency of aberrant opioid use behaviors(Up to 90 days post surgery)
- Frequency of positive risk of opioid use disorder(Up to 90 days post surgery)