Clinical trial · Interventional
Effects of Bright Light on Sleep Quality, Fatigue , and Mood Symptoms in Survivors With Gynecologic Cancer
The Effect of Bright Light Therapy on Sleep Quality, Cancer-Related Fatigue, and Emotional Symptoms in Gynecologic Cancer Survivors: A Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fatigue | — | UNRESOLVED | — |
| Gynecologic Cancer Survivors | — | UNRESOLVED | — |
| Mood Symptoms | — | UNRESOLVED | — |
| Sleep Quality | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Re-Timer® light therapy glasses | Device | — | UNRESOLVED |
| Usual Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Bright Light Intervention Group
- description
- 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.
- interventionNames
- Device: Re-Timer® light therapy glasses
- type
- OTHER
- label
- Usual Care
- description
- Participants in this group received usual care and did not receive any light therapy intervention during the study period.
- interventionNames
- Other: Usual Care
Primary outcomes (1)
- measure
- Change in Insomnia Severity Index - Chinese version (ISI-C)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female participants aged 18 years or older. 2. 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. 3. Insomnia Severity Index-Chinese Version (ISI-C) score ≥ 9, indicating clinical insomnia (Yang et al., 2009). 4. If currently using psychiatric medications, the dosage must have remained stable for at least 6 weeks prior to participation. 5. Able to speak Mandarin or Taiwanese fluently and read and write in Chinese. 6. Able to use a smartphone. 7. Conscious, capable of understanding the study procedures, willing to sign informed consent, and agree to participate. Exclusion Criteria: 1. History of psychiatric hospitalization or severe psychiatric disorders within the past 6 months. 2. Eye diseases or ophthalmologic surgery within the past two weeks, conditions contraindicating light therapy, or use of photosensitizing drugs (e.g., cataracts). 3. Currently taking hypnotic medications. 4. Habitual smoking or alcohol use. 5. Working night shifts, rotating shifts, or frequent travel across multiple time zones. 6. Currently pregnant.
References
Publications (3)
- BACKGROUNDLin LY, Tam KW, Huang TW. Effect of bright light therapy on cancer-related fatigue and related symptoms: A systematic review and meta-analysis of randomized controlled trials. J Psychosom Res. 2023 Nov;174:111501. doi: 10.1016/j.jpsychores.2023.111501. Epub 2023 Sep 27. PMID 37797569
- BACKGROUNDFox RS, Baik SH, McGinty H, Garcia SF, Reid KJ, Bovbjerg K, Fajardo P, Wu LM, Shahabi S, Ong JC, Zee PC, Penedo FJ. Feasibility and Preliminary Efficacy of a Bright Light Intervention in Ovarian and Endometrial Cancer Survivors. Int J Behav Med. 2021 Feb;28(1):83-95. doi: 10.1007/s12529-020-09861-0. PMID 32080797
- BACKGROUNDOzerdogan N, Ozkaraman A, Tuncer Yilmaz B, Oge T, Yalcin OT. The Effect of Bright White Light on Fatigue Levels in Patients with Gynecological Cancer: A Randomized Control Trial. J Palliat Care. 2023 Oct;38(4):416-423. doi: 10.1177/08258597221127795. Epub 2022 Sep 25. PMID 36154518