Improving Sleep Quality, Psychosocial Functioning, and Cancer Related Fatigue With Light Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 9
- 主要终点
- Cancer related fatigue
研究概览
简要总结
Cancer related fatigue (CRF) is one of the most prevalent and distressing long-term complaints reported by (non-) Hodgkin survivors. The SPARKLE study will test the efficacy of two intensities of light therapy on cancer related fatigue. Additionally, it explores possible working mechanisms of light therapy on CRF including improvements in sleep quality, psychosocial variables (depression, anxiety, cognitive complaints, and quality of life), and changes in biological circadian rhythms.
详细描述
Rationale: Cancer related fatigue (CRF) is one of the most prevalent and distressing long-term complaints reported by (non-)Hodgkin survivors. So far, there is no standard treatment. Some non-pharmacological interventions have shown large effects but show limitations as well, e.g. they are labor intensive. A novel and promising treatment for CRF is exposure to bright white light (BWL) therapy. This low-cost intervention is easy to deliver and has a low burden for professionals as well as for patients.
Objective: To examine the efficacy of BWL therapy as an intervention for CRF. As a secondary aim, this study will explore possible working mechanisms including changes in sleep quality, psychological variables, biological circadian rhythms, sleep-wake cycles, inflammation markers and genotype.
Study design: A multicenter randomized controlled trial will invite participants and allocate them to either a light intensity 1 condition (n=80) or a light intensity 2 condition (n=80). The longitudinal design will include four measurement points: baseline, mid-intervention, post-intervention, and at 3 and 9 months follow-up.
Study population: Hodgkin and diffuse large B-cell lymphoma (DLBCL) survivors fulfilling the clinical criteria of CRF and a survivorship of ≥ 3 years will be invited. Fatigue should not be attributable to a clear somatic cause or treatment for secondary cancer in the past year. Moreover, 25 Hodgkin survivors without CRF will be recruited to explore the association between circadian rhythms and CRF.
Intervention: The light intervention includes exposure to light for 30 minutes within the first half hour after awakening during 3,5 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A history of Hodgkin or DLBCL with a survivorship of ≥ 3 years.
- •The presence of moderate to severe fatigue symptoms since diagnosis of or treatment for Hodgkin lymphoma or DLBCL.
排除标准
- •Fatigue is explained by a somatic factor as defined in the guidelines of chronic fatigue syndrome of the Dutch internists association (NIV). When a somatic cause for fatigue is resolved by stable medication use ≥ 6 months, patients can be included in the current trial.
- •Pregnancy (until 3 months postnatal) or women who provide breast feeding
- •Extensive surgical operations in the past 3 months.
- •Current diagnosis of a psychiatric disorder (e.g. personality disorders, psychosis, bipolar disorder) which would limit participation.
- •Diagnosis of and treatment for a secondary malignancy in the past 12 months.
- •Presence of photophobia (abnormal intolerance to visual perception of light) or another eye disease that shows symptoms of photophobia (e.g. aniridia, retinitis pigmentosa, glaucoma).
- •Current or previous use of light therapy for more than 1 week.
- •Current employment in shift work.
- •Insufficient knowledge of the Dutch language.
研究组 & 干预措施
Light intensity 1
The light intervention includes exposure to white light (10.000 lux) at a distance of 45 cm for 30 minutes within the first half hour after awakening during 3 weeks and 4 days. This can be done while engaged in other activities, for example reading the newspaper or eating breakfast.
干预措施: Light therapy intensity 1 (Device)
Light intensity 2
The light intervention includes exposure to white light (10-20 lux) at a distance of 45 cm for 30 minutes within the first half hour after awakening during 3 weeks and 4 days. This can be done while engaged in other activities, for example reading the newspaper or eating breakfast.
干预措施: Light therapy intensity 2 (Device)
结局指标
主要结局
Cancer related fatigue
时间窗: Change from baseline fatigue at 9 months after light therapy
Fatigue is assessed with the Multidimensional Fatigue
Cancer related fatigue
时间窗: Change from baseline fatigue at end of 3,5 weeks light therapy
Fatigue is assessed with the Multidimensional Fatigue Inventory
Cancer related fatigue
时间窗: Change from baseline fatigue at 3 months after light therapy
Fatigue is assessed with the Multidimensional Fatigue
次要结局
- Subjective cognitive complaints(Change from baseline subjective cognitive complaints at 9 months after light therapy)
- Objective cognitive complaints - long-term memory(Change from baseline objective cognitive complaints at end of 3,5 weeks light therapy)
- Objective cognitive complaints - short-term memory(Change from baseline objective cognitive complaints at end of 3,5 weeks light therapy)
- Cancer worries(Change from baseline cancer worries at 9 months after light therapy)
- Fatigue catastrophizing(Baseline)
- Self-efficacy(Baseline)
- Circadian rhythms of cortisol and melatonin(Change from baseline circadian rhythms at end of 3,5 weeks light therapy)
- Objective sleep quality(Change from baseline objective sleep quality at 9 months after light therapy)
- Anxiety(Change from baseline anxiety at 9 months after light therapy)
- Quality of life(Change from baseline quality of life at 9 months after light therapy)
- Objective cognitive complaints - alertness and sustained attention(Change from baseline objective cognitive complaints at end of 3,5 weeks light therapy)
- Subjective sleep quality(Change from baseline subjective sleep quality at 9 months after light therapy)
- Depression(Change from baseline depression at 9 months after light therapy)
- Biomarkers of inflammation and genotype(Change from baseline levels of biomarkers at end of 3,5 weeks light therapy)
- Subjective sleep quality(Change from baseline subjective sleep quality at end of 3,5 weeks light therapy)
- Subjective sleep quality(Change from baseline subjective sleep quality at 3 months after light therapy)
- Objective sleep quality(Change from baseline objective sleep quality at end of 3,5 weeks light therapy)
- Objective sleep quality(Change from baseline objective sleep quality at 3 months after light therapy)
- Depression(Change from baseline depression at end of 3,5 weeks light therapy)
- Depression(Change from baseline depression at 3 months after light therapy)
- Anxiety(Change from baseline anxiety at end of 3,5 weeks light therapy)
- Anxiety(Change from baseline anxiety at 3 months after light therapy)
- Quality of life(Change from baseline quality of life at end of 3,5 weeks light therapy)
- Quality of life(Change from baseline quality of life at 3 months after light therapy)
- Subjective cognitive complaints(Change from baseline subjective cognitive complaints at end of 3,5 weeks light therapy)
- Subjective cognitive complaints(Change from baseline subjective cognitive complaints at 3 months after light therapy)
- Cancer worries(Change from baseline cancer worries at end of 3,5 weeks light therapy)
- Cancer worries(Change from baseline cancer worries at 3 months after light therapy)