Reducing Cancer Side-effects With Systematic Light Exposure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Cancer-related fatigue (FACIT-fatigue)
研究概览
简要总结
The main purpose of this interdisciplinary proposal is to conduct two randomized controlled trial (RCT) of the efficacy of self-administered systematic light exposure (Bright White Light (BWL)), an innovative, low cost, and low burden intervention to treat cancer-related fatigue. Another common and often overlapping treatment side-effect is cognitive impairment. A secondary outcome of the proposed RCT is, thus, cognitive functioning. Finally, possible underlying chronobiological (circadian activity rhythms, sleep), biological (pro inflammatory markers), and neurophysiological (brain morphology) mechanisms of BWL will be explored.
详细描述
Two independent but similar RCTs with a total of 144 breast cancer patients (Group 1 = 72 high risk patients; Group 2 = 72 low risk breast cancer patients) post-treatment screened for fatigue will be randomized to BWL (36 in each of the two groups) or dim light(DL) (36 in each of the two groups) exposure for 30 minutes/morning for 4 weeks, and assessed before, during, immediately and 3 months after the intervention. Measures include questionnaires, cognitive assessment, actigraphy, blood samples, saliva samples, and magnetic resonance imaging (MRI).
1.1 Aims and hypotheses. Aim 1: To test the efficacy of BWL on fatigue (primary outcome) in breast cancer patients.
Hypothesis 1: Compared with control participants exposed to DL, participants randomized to BWL will report less fatigue immediately and 3 months after the intervention.
Aim 2: To test the efficacy of BWL on cognitive functioning (secondary outcome).
Hypothesis 2: Compared with controls, BWL recipients will show improved cognitive functioning immediately and 3 months after the intervention.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •High-risk breast cancer patients as defined by the Danish Breast Cancer Cooperative Group (DBCG) having received treatment according to the DBCG guidelines
- •Minimum age of 18 years; completion of adjuvant whole breast radiation treatments
- •A score <34 on the FACIT-Fatigue scale (see below) after radiotherapy
- •Availability for home-based 4-week BWL/DL-treatment.
排除标准
- •History of chronic fatigue disorders
- •Pregnancy
- •Confounding underlying medical illnesses such as significant pre-existing anemia
- •Diagnosed or suspected psychiatric or medical condition that might contribute to fatigue (other than those caused by the cancer or its treatment)
- •History of bipolar disease or mania (which are contra-indications for light treatment)
- •Current clinical depression
- •History of seasonal affective disorder
- •Previous diagnosis of sleep apnea, restless legs or other sleep disorders (not including insomnia) known to affect fatigue
- •Employment in shift work
- •Chronic use of oral steroid medication
- •Prior use of light treatment
- •Use of photosensitising medications
- •Plans to travel across meridians
- •Insufficient Danish language proficiency
- •Inclusion criteria - Group 2:
- •Low-risk postmenopausal patients as defined by the DBCG having received breast-conserving surgery for lymph node-negative breast cancer
- •Completion of adjuvant whole breast radiation treatments
- •A score <34 on the FACIT Fatigue scale (see below) after radiotherapy
- •Availability for home-based 4-week BWL/DL-treatment.
- •Exclusion Criteria:
- •History of chronic fatigue disorders
- •Pregnancy
- •Confounding underlying medical illnesses such as significant pre-existing anemia
- •Diagnosed or suspected psychiatric or medical condition that might contribute to fatigue (other than those caused by the cancer or its treatment)
- •History of bipolar disease or mania (which are contra-indications for light treatment)
- •Current clinical depression
- •History of seasonal affective disorder
- •Previous diagnosis of sleep apnea, restless legs or other sleep disorders (not including insomnia) known to affect fatigue
- •Employment in shift work
- •Chronic use of oral steroid medication
- •Prior use of light treatment
- •Use of photosensitising medications
- •Plans to travel across meridians
- •Insufficient Danish language proficiency
结局指标
主要结局
Cancer-related fatigue (FACIT-fatigue)
时间窗: Changes in fatigue from baseline to 3 months after intervention
次要结局
- Connors Continous performance test (CPT-3)(Immediately after intervention)
- Health-related quality of life (SF-36)(Immediately after intervention and 3 months after intervention)
- Pittsburgh Sleep Quality Index (PSQI)(Immediately after intervention and 3 months after intervention)
- Anxiety symptoms (HADS Anxiety)(Immediately after intervention and 3 months after intervention)
- Psychomotor vigilance test (PVT)(Immediately after intervention)
- Hopkins Verbal Learning Test (HVLT-R)(Immediately after intervention)
- Patients assessment of own functioning Inventory (POAFI)(Immediately after intervention and 3 months after intervention)
- Overall neuropsychological composite score(Immediately after intervention and 3 months after intervention)
- Beck's Depression Inventory - II (BDI-II)(Immediately after intervention and 3 months after intervention)
- Impact of events (IES-R)(Immediately after intervention and 3 months after intervention)
研究者
Ali Amidi
Cand.psych, Ph.D.
Aarhus University Hospital