Sleep Disturbance and Its Association With Fatigue, Depressive Symptoms, and Clinical Response to Immune Checkpoint Inhibitors (ICI) in Lung Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Clinical response to treatment
研究概览
简要总结
Sleep disturbances are prevalent in cancer patients and linked to levels of fatigue and depressive symptoms with a major impact on quality of life. A growing body of evidence links sleep disturbances with various health outcomes, including increased risk of depression, cancer, and overall mortality. Inflammation is suggested to be an underlying mechanism both driving and maintaining the symptom cluster of sleep disturbance, fatigue and depressive symptoms, as well as being bi-directionally linked to sleep. The main purpose of the present study is to investigate the prevalence of sleep disturbance and its association with psychological and physical symptoms as well as the clinical response to ICI in non-small-cell lung cancer patients (NSCLC), with a secondary aim of exploring the role of inflammation.
详细描述
A total of 240 cancer patients diagnosed with advanced NSCLC, referred to treatment with ICI will be enrolled in this prospective observational study. Patients will be assessed prior to initiation of treatment (baseline) and every third subsequent week, corresponding to each treatment cycle over a period of 18 weeks. Assessments will include questionnaires, sleep diaries, actigraphy, and blood and saliva samples to examine sleep, fatigue, psychological and physical symptoms, the sleep-wake-cycle, inflammation, and cortisol. Additionally, the patients will be asked to complete a reduced questionnaire every week within the 18 weeks period, to address weekly fluctuations in sleep quality, fatigue, and mood. Treatment response is assessed after 9 and 18 weeks.
Aims:
- To explore possible associations between sleep and the clinical response to treatment with ICI.
- To investigate the prevalence of sleep disturbance in patients with NSCLC during treatment with ICI.
- To prospectively assess changes in sleep parameters over the course of treatment.
- To examine associations between sleep parameters and fatigue, depression, anxiety, and inflammation.
- To explore possible associations between sleep, fatigue, depression, inflammatory responses and the clinical response to treatment with ICIs.
Hypotheses:
Patients with high levels of sleep disturbance (insomnia severity) will experience 1) poorer clinical response to ICI, 2) more depressive symptoms, 3) higher levels of fatigue, 4) poorer overall health-related quality of life (HRQoL), 5) higher levels of inflammation.
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
- •Confirmed diagnosis of advanced non-small cell lung cancer
排除标准
- •Insufficient Danish proficiency
- •Pre-existing confounding psychiatric illnesses
结局指标
主要结局
Clinical response to treatment
时间窗: Changes from baseline to 9 and 18 weeks after treatment initiation, respectively.
Radiological evaluation of the clinical response to treatment with ICI, according to RECIST criteria.
次要结局
- Actigraphy 3(Baseline to 18 weeks after initiation of treatment.)
- Perceived Stress(Baseline, and week 3, 6, 9, 12, 15 and 18, respectively, and follow-up 1, 2 and 3 years from baseline, respectively.)
- Inflammatory response 1(Baseline, and week 3, 6, 9, 12, 15 and 18, respectively.)
- Health-related quality of life(Baseline, and week 3, 6, 9, 12, 15 and 18, respectively, and follow-up 1, 2 and 3 years from baseline, respectively.)
- Actigraphy 4(Baseline to 18 weeks after initiation of treatment.)
- Insomnia Severity(Weekly from baseline to 18 weeks after treatment initiation, and follow-up 1, 2 and 3 years from baseline, respectively.)
- Cortisol(Baseline, and week 3, 6, 9, 12, 15 and 18, respectively.)
- Inflammatory response 3(Baseline, and week 3, 6, 9, 12, 15 and 18, respectively.)
- Sleep diary(Baseline, and week 3, 6, 9, 12, 15 and 18, respectively.)
- Fatigue(Baseline, and week 3, 6, 9, 12, 15 and 18, respectively, and follow-up 1, 2 and 3 years from baseline, respectively.)
- Depressive symptoms(Baseline, and week 3, 6, 9, 12, 15 and 18, respectively, and follow-up 1, 2 and 3 years from baseline, respectively.)
- Disease specific health-related quality of life(Baseline, and week 3, 6, 9, 12, 15 and 18, respectively, and follow-up 1, 2 and 3 years from baseline, respectively.)
- Sickness behavior(Baseline, and week 3, 6, 9, 12, 15 and 18, respectively, and follow-up 1, 2 and 3 years from baseline, respectively.)
- Inflammatory response 5(Baseline, and week 3, 6, 9, 12, 15 and 18, respectively.)
- Inflammatory response 2(Baseline, and week 3, 6, 9, 12, 15 and 18, respectively.)
- Inflammatory response 4(Baseline, and week 3, 6, 9, 12, 15 and 18, respectively.)
- Actigraphy 1(Baseline to 18 weeks after initiation of treatment.)
- Actigraphy 2(Baseline to 18 weeks after initiation of treatment.)
- Actigraphy 6(Baseline to 18 weeks after initiation of treatment.)
- Actigraphy 5(Baseline to 18 weeks after initiation of treatment.)
- Disease status(1, 2 and 3 years from treatment initiation (baseline).)
研究者
Louise Strøm
PhD-fellow
University of Aarhus