Sleep Disturbances in Surgical Patients With GI Cancers: A Quantitative and Qualitative Analysis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Correlating the sleep disturbance and its types among patients with gastrointestinal cancers.
研究概览
简要总结
The primary objective of the study is to determine sleep disturbance and its types among patients with gastrointestinal cancers during the perioperative period (preoperative and in-hospital stay following surgery) by using Richard Campbell sleep questionnaire (RCSQ).
The primary objective of this study is to determine the SD during preoperative and post-operative periods evaluated by Richard Campbell Sleep questionnaire. Patients will be asked every 24 hours while at the hospital (before and after surgery) to fill out this questionnaire. The mean RCSQ score at each time point (i.e., before and after surgery) will be calculated for each patient. The overall mean (across all patients) will be calculated and reported along a 95% CI.
详细描述
Primary:
• Determine sleep disturbance and its types among patients with gastrointestinal cancers during the perioperative period (preoperative and in-hospital stay following surgery) by using Richard Campbell sleep questionnaire(RCSQ).
Secondary:
- Determine sleep disturbance and its types at 30 day post-discharge follow-up visit by RCSQ.
- Determine the correlation between objective sleep variables assessed using Actigraphy and Fitbit and patient-reported SD on Richard Campbell Sleep questionnaire.
- Determine the association of severity and impact of SD among Quality of recovery (QoR-15), Pittsburgh sleep quality index, MDASI-GI and Richard Campbell Sleep questionnaire, and Insomnia Severity Index (ISI).
Exploratory:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
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
- •Adult GI Cancer patients admitted for elective gastrointestinal surgery.
- •Patients with an expected hospitalstay of at least 72 hours.
- •Able to be able to read and speak English.
- •Must have access to internet or use of mobile device for FitBit.
排除标准
- •<18 years of age.
- •Night shift workers. Obtained from job history, any patient >/= 2 days per week, within the last six months prior consenting, are not eligible.
研究组 & 干预措施
Sleep Disturbances
Difficulty Sleeping
干预措施: Sleeping Disturbances (Other)
结局指标
主要结局
Correlating the sleep disturbance and its types among patients with gastrointestinal cancers.
时间窗: through study completion, an average of 1 year
This questionnaire will be used to assess during the stay by using (preoperative and in-hospital stay following surgery) by using Richard Campbell sleep questionnaire(RCSQ). scale of 1 to 10 (with 1 being "poor" and 10 being "excellent
次要结局
未报告次要终点