Effects of Bright Light on Sleep Quality, Fatigue , and Mood Symptoms in Survivors With Gynecologic Cancer
NCT07132580 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 94
Last updated 2025-08-20
Summary
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.
Conditions
- Gynecologic Cancer Survivors
- Sleep Quality
- Fatigue
- Mood Symptoms
Interventions
- DEVICE
-
Re-Timer® light therapy glasses
Participants wore Re-Timer® glasses that emitted bright white light at 506 lux for 30 minutes each morning, over a 4-week intervention period.
- OTHER
-
Usual Care
Participants received standard follow-up care with no light therapy intervention during the 4-week period.
Sponsors & Collaborators
-
National Taipei University of Nursing and Health Sciences
collaborator OTHER -
Chang Gung Memorial Hospital
lead OTHER
Principal Investigators
-
Lingya Hsu, MSN, RN · Chang Gung Memorial Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-05-20
- Primary Completion
- 2024-11-27
- Completion
- 2025-03-07
Countries
- Taiwan
Study Locations
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