Evaluation of Sleep Quality in Head and Neck Cancer Patients Throughout Treatment Course
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Per-patient average score on Richards-Campbell Sleep Questionnaire
研究概览
简要总结
This study examines how head and neck cancer treatment affects quality of sleep over time and factors that contribute to sleep quality. Sleep plays a critical role in healing and quality of life, and recent studies investigating sleep disorders in head and neck cancer patients reveal sleep quality is a major determinant of post-treatment outcomes. Information from this study may help researchers better understand how treatment impacts sleep quality so that they can make changes that may help improve patient sleep quality.
详细描述
PRIMARY OBJECTIVES:
I. To describe the five (5) components of sleep quality in head and neck patients under different stages of post-op treatment and different environment.
II. To evaluate the effect of surgery, treatment and environment on the five (5) components of sleep quality in head and neck cancer patients.
SECONDARY OBJECTIVES:
I. To evaluate the association between the five (5) components of sleep quality and comorbid obstructive sleep apnea (STOP-BANG and Epworth Sleeping Scale) and depression (Patient Health Questionnaire-2 [PHQ-2]), under different stages of post-op treatment and different environment.
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
- •Males and females
- •Adult at least 18 years old
- •Capable of giving informed consent
- •Diagnosed with head and neck cancer (previously untreated, any stage)
- •Treatment plan involves surgery
- •Willing to comply with all study procedures and be available for the duration of the study
- •English-speaking
排除标准
- •Non-English speaking
- •Pre-existing sleep disorder defined below:
- •Obstructive sleep apnea
- •Narcolepsy
- •Restless leg syndrome
- •Rapid eye movement (REM) sleep behavior disorder
结局指标
主要结局
Per-patient average score on Richards-Campbell Sleep Questionnaire
时间窗: Up to study completion; approximately 12 months
Barriers to sleep quality
时间窗: Up to study completion; approximately 12 months
Time in bed
时间窗: Up to study completion; approximately 12 months
The time difference between time to get into bed and time to get up, measured in minutes
Sleep latency
时间窗: Up to study completion; approximately 12 months
How long it takes to sleep, measured in minutes.
Sleep maintenance latency
时间窗: Up to study completion; approximately 12 months
How long it takes to fall back to sleep, measured in minutes.
Per-patient sum of scores on Epworth Sleepiness Scale
时间窗: Up to study completion; approximately 12 months
Sleep hygiene
时间窗: Up to study completion; approximately 12 months
Number of nighttime awakening
时间窗: Up to study completion; approximately 12 months
Per-patient sum of positive responses on STOP-BANG
时间窗: Up to study completion; approximately 12 months
Per-patient sum of scores on Patient Health Questionnaire-2
时间窗: Up to study completion; approximately 12 months
次要结局
未报告次要终点