The Effect of Bright Light Therapy on Sleep Quality, Cancer-Related Fatigue, and Emotional Symptoms in Gynecologic Cancer Survivors: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Change in Insomnia Severity Index - Chinese version (ISI-C)
研究概览
简要总结
Objective: This study aimed to examine the efficacy of light therapy in improving sleep quality, reducing fatigue, and alleviating emotional symptoms among patients diagnosed with gynecologic cancer.
Methods: A randomized controlled trial was conducted at a medical center in northern Taiwan. Inclusion criteria included patients aged 18 years or older with a physician-confirmed diagnosis of gynecologic cancer and a score of ≥ 9 on the Chinese version of the Insomnia Severity Index (ISI-C). Eligible participants were randomly assigned to an experimental group or a control group (each with 47 subjects). At baseline (T0), all participants completed a demographic and treatment questionnaire, the ISI-C, the Taiwan version of the Brief Fatigue Inventory (BFI-T), and the Distress Thermometer (DT). The experimental group then underwent daily light therapy sessions via a circadian regulator for 30-40 minutes within 30 minutes of waking for four weeks. Meanwhile, the control group continued their usual routines during the same period. Follow-up assessments were conducted on days 7 (T1), 14 (T2), 21 (T3), and 28 (T4) post-intervention. Data was analyzed using SPSS 26.0, and generalized estimating equations (GEE) were employed to assess the effectiveness of light therapy.
Results: Generalized Estimating Equations (GEE) will be applied to examine group differences over time in sleep quality, fatigue, and emotional symptoms, in order to assess the effects of the intervention.
Conclusion: Light therapy is proposed as a potentially safe, low-risk, and cost-effective non-pharmacological intervention for improving sleep quality, reducing fatigue, and alleviating emotional distress in patients with gynecologic cancer following chemotherapy. This study is designed to evaluate the feasibility and potential effects of light therapy in this population, with the goal of informing future clinical applications.
详细描述
Background and Rationale
Survivors of gynecologic cancers often experience persistent sleep disturbances, cancer-related fatigue, and emotional distress even after treatment has ended. These symptoms can significantly affect daily functioning, emotional well-being, and overall quality of life. Bright light therapy (BLT), a non-pharmacological intervention, has been shown in other populations to help regulate circadian rhythms and improve sleep and fatigue by suppressing melatonin levels. However, the application of BLT in gynecologic cancer survivors has not been well studied. This trial is designed to explore the potential of BLT in addressing these symptoms in this specific population.
Objectives
The primary objective is to evaluate the effects of a four-week bright light therapy intervention on sleep quality, fatigue, and emotional symptoms among gynecologic cancer survivors. It is hypothesized that participants receiving BLT will demonstrate improved outcomes in these domains compared to those receiving usual care.
Study Design
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
- None
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
- •Female participants aged 18 years or older.
- •Diagnosed with ovarian cancer, cervical cancer, fallopian tube cancer, or endometrial cancer, and have completed primary treatment (surgery, chemotherapy, or radiation) for more than 3 months, Currently in the treatment stage.
- •Insomnia Severity Index-Chinese Version (ISI-C) score ≥ 9, indicating clinical insomnia (Yang et al., 2009).
- •If currently using psychiatric medications, the dosage must have remained stable for at least 6 weeks prior to participation.
- •Able to speak Mandarin or Taiwanese fluently and read and write in Chinese.
- •Able to use a smartphone.
- •Conscious, capable of understanding the study procedures, willing to sign informed consent, and agree to participate.
排除标准
- •History of psychiatric hospitalization or severe psychiatric disorders within the past 6 months.
- •Eye diseases or ophthalmologic surgery within the past two weeks, conditions contraindicating light therapy, or use of photosensitizing drugs (e.g., cataracts).
- •Currently taking hypnotic medications.
- •Habitual smoking or alcohol use.
- •Working night shifts, rotating shifts, or frequent travel across multiple time zones.
- •Currently pregnant.
研究组 & 干预措施
Usual Care
Participants in this group received usual care and did not receive any light therapy intervention during the study period.
干预措施: Usual Care (Other)
Bright Light Intervention Group
Participants in this group received daily morning exposure to bright white light (506 lux) using the Re-Timer® light therapy glasses for 45 minutes per day, over a 4-week period.
干预措施: Re-Timer® light therapy glasses (Device)
结局指标
主要结局
Change in Insomnia Severity Index - Chinese version (ISI-C)
时间窗: Day 7 (T1), Day 14 (T2), Day 21 (T3), and Day 28 (T4) after intervention start.
To evaluate the change in insomnia severity before and after the intervention using the Insomnia Severity Index - Chinese version (ISI-C). Higher scores indicate more severe insomnia.
次要结局
- Cancer-related fatigue (BFI-T)(Day 7 (T1), Day 14 (T2), Day 21 (T3), and Day 28 (T4) after the start of the intervention.)
- Emotional distress (Distress Thermometer, DT)(Day 7 (T1), Day 14 (T2), Day 21 (T3), and Day 28 (T4) after the start of the intervention.)