The RALI Study: a Multimodal Non-pharmacological (Clinical Review, Physical Activity, Bright Light Therapy and Cognitive Behavioural Therapy for Insomnia) Feasibility Trial for Circadian Rest-activity Rhythm Disorders in Patients With Advanced Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Adverse events
研究概览
简要总结
Circadian rest-activity rhythm disorders are common in patients with cancer, particularly in advanced disease. A recent international e-Delphi study has outlined recommendations for the assessment and reporting of the disorder and subsequently an observation study is underway assessing a cohort of patients with advanced cancer. Affected patients are eligible to enter a feasibility study assessing a non-pharmacological multi-modal intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Age ≥18 years old
- •Diagnosis of advanced cancer (locally advanced, incurable, metastatic)
- •Estimated prognosis ≥ 3 months
- •Evidence of a circadian rest-activity rhythm disorder
排除标准
- •Engaged in shift-work
- •Long-haul travel in the last 14 days
- •Physical impairment limiting movement of the non-dominant arm
- •Cognitive impairment limiting the ability to complete the assessment tool and/or patient diary
- •Uncontrolled high blood pressure or tachycardia
- •Exercise-related symptoms and signs (e.g. chest pain, syncope, limb claudication, hypoxia at rest)
- •Participant has a history of uncontrolled mania or bipolar disorder
- •Participant has a recent history or current thoughts of self-harm or suicide
- •Participant has a recent change in antidepressant medication
- •Participant has an eye disorder (e.g. glaucoma, cataracts, retinopathy)
结局指标
主要结局
Adverse events
时间窗: Outcome assessed weekly during an 8-week trial
Number of subjects develop adverse events during the trial in accordance with the Common Terminology Criteria for Adverse Events (CTCAE)
Acceptability and usability of a multi-modal non-pharmacological intervention
时间窗: At the end of 8-weeks
Patient completed questionnaire of the acceptability and usability of interventions and research assessments
Completion rates of research assessments
时间窗: Completed at baseline, week 2, week 4 and week 8
Number of participants completing the midpoint and end of study assessments
Adherence to interventions
时间窗: Outcome assessed weekly during the 8-week trial
Patient completed weekly diary of adherence to the interventions and weekly monitoring by the researcher
Recruitment rate
时间窗: 1 year
Number of participants recruited to the feasibility study over a 1 year period
次要结局
- Symptom assessment(Time 1 (baseline), Time 2 (end of 4 weeks), Time 3 (end of 8 weeks))
- Physical activity assessment(Continuous midweek 72-hour monitoring at baseline, Continuous midweek 72-hour monitoring during week 7)
- Daytime Sleepiness(Time 1 (baseline), Time 2 (end of 4 weeks), Time 3 (end of 8 weeks))
- Physical activity and sleep assessment(Continuous midweek 72-hour monitoring at baseline, Continuous midweek 72-hour monitoring during week 7)
- Quality of Life assessment(Time 1 (baseline), Time 2 (end of 4 weeks), Time 3 (end of 8 weeks))
- Sleep Quality(Time 1 (baseline), Time 2 (end of 4 weeks), Time 3 (end of 8 weeks))
研究者
Prof Andrew Davies
Professor of Palliative Medicine
University of Dublin, Trinity College