NCT06023654已完成不适用
Preliminary Validation of a Novel Screening Tool and Diagnostic Criteria to Identify Circadian Rest-Activity Rhythm Disorders in Patients With Advanced Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- To measure preliminary concurrent validity of a novel screening tool to identify Circadian rest-Activity Rhythm Disorders in patients with advanced cancer against diagnostic criteria
研究概览
简要总结
Circadian rest-Activity Rhythm disorders (CARDs) are common in patients with cancer, particularly in advanced disease. CARDs are associated with increased symptoms, poorer quality of life, poorer response to anticancer treatments and shorter survival.
The goal of this observational study is to see how common CARDs are in patients with advanced cancer and to characterise their rest and activity patterns in more detail.
A recent study has outlined a standard way to assess and diagnose a CARD.
This study aims to assess patients with advanced cancer for a CARD using a novel screening tool against this newly formed diagnostic criteria. Potentially modifiable risk factors will be considered along with associations between CARDs and symptoms, sleep preferences, sleep quality, daytime sleepiness, quality of life measures and predictors of survival.
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
- •Adult (18 years of age or older)
- •Locally advanced or metastatic cancer
- •Outpatient
- •Ambulatory
- •Prognosis of 3 months or more
排除标准
- •Inpatient
- •Shiftworker
- •Recent long-haul travel
- •Cognitive impairment impacting on ability to complete questionnaires
结局指标
主要结局
To measure preliminary concurrent validity of a novel screening tool to identify Circadian rest-Activity Rhythm Disorders in patients with advanced cancer against diagnostic criteria
时间窗: Time 1 (baseline), Time 2 (after 72 consecutive hours of accelerometry monitoring)
Assessing the sensitivity and specificity of the screening tool
次要结局
- To assess the relationship between past medical history and the risk of developing a Circadian rest-Activity Rhythms in patients with cancer(Time 2 (after 72 consecutive hours of accelerometry monitoring))
- To measure acceptability and ease of use of a novel screening tool to identify Circadian rest-Activity Rhythm Disorders in patients with advanced cancer(Time 2 (after 72 consecutive hours of accelerometry monitoring))
- To assess rest and physical activity patterns in patients with advanced cancer(Time 2 (after 72 consecutive hours of accelerometry monitoring))
- To measure test-retest reliability of a novel screening tool to identify Circadian rest-Activity Rhythm Disorders in patients with advanced cancer(Time 1 (baseline), Time 2 (after 72 consecutive hours of accelerometry monitoring))
- To identify the incidence of Circadian rest-activity Rhythm Disorders in patients with advanced cancer(Time 2 (after 72 consecutive hours of accelerometry monitoring))
- To measure acceptability and ease of use of a novel sleep and activity diary in patients with advanced cancer(Time 2 (after 72 consecutive hours of accelerometry monitoring))
- To assess the relationship between demographic details and the risk of developing a Circadian rest-Activity Rhythms in patients with cancer(Time 2 (after 72 consecutive hours of accelerometry monitoring))
- To assess associations between Circadian rest-activity Rhythm Disorders in patients with advanced cancer with quality of life(Time 2 (after 72 consecutive hours of accelerometry monitoring))
- To assess associations between Circadian rest-activity Rhythm Disorders in patients with advanced cancer with sleep quality(Time 2 (after 72 consecutive hours of accelerometry monitoring))
- To assess associations between Circadian rest-activity Rhythm Disorders in patients with advanced cancer with daytime sleepiness(Time 2 (after 72 consecutive hours of accelerometry monitoring))
- To assess the relationship between chronotype and the risk of develop a Circadian rest-Activity Rhythms in patients with cancer(Time 2 (after 72 consecutive hours of accelerometry monitoring))
- To assess associations between Circadian rest-activity Rhythm Disorders in patients with advanced cancer and prognosis(Time 2 (after 72 consecutive hours of accelerometry monitoring))
- To assess the relationship between occupation and the risk of developing a Circadian rest-Activity Rhythms in patients with cancer(Time 2 (after 72 consecutive hours of accelerometry monitoring))
- To assess the relationship between alcohol consumption and the risk of developing a Circadian rest-Activity Rhythms in patients with cancer(During 72 hours period of monitoring)
- To assess associations between Circadian rest-activity Rhythm Disorders in patients with advanced cancer with symptoms(Time 2 (after 72 consecutive hours of accelerometry monitoring))
- To assess the relationship between caffeine consumption and the risk of developing a Circadian rest-Activity Rhythms in patients with cancer(During 72 hours period of monitoring)
- To assess the relationship between current medication use and the risk of developing a Circadian rest-Activity Rhythms in patients with cancer(Time 2 (after 72 consecutive hours of accelerometry monitoring))
- To assess the relationship between cigarette use and the risk of developing a Circadian rest-Activity Rhythms in patients with cancer(During 72 hours period of monitoring)
研究者
Prof Andrew Davies
Professor of Palliative Medicine
University of Dublin, Trinity College
研究点 (2)
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