NCT07132580

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 20, 2025

Completed
Last Updated

August 20, 2025

Status Verified

August 1, 2025

Enrollment Period

6 months

First QC Date

August 10, 2025

Last Update Submit

August 17, 2025

Conditions

Gynecologic Cancer SurvivorsSleep QualityFatigueMood Symptoms

Keywords

light therapygynecologic cancerchemotherapysleep qualityfatigueemotional symptoms

Outcome Measures

Primary Outcomes (1)

  • Change in Insomnia Severity Index - Chinese version (ISI-C)

    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.

    Day 7 (T1), Day 14 (T2), Day 21 (T3), and Day 28 (T4) after intervention start.

Secondary Outcomes (2)

  • 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.

Study Arms (2)

Bright Light Intervention Group

EXPERIMENTAL

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.

Device: Re-Timer® light therapy glasses

Usual Care

OTHER

Participants in this group received usual care and did not receive any light therapy intervention during the study period.

Other: Usual Care

Interventions

Re-Timer® light therapy glassesDEVICE

Participants wore Re-Timer® glasses that emitted bright white light at 506 lux for 30 minutes each morning, over a 4-week intervention period.

Bright Light Intervention Group
Usual CareOTHER

Participants received standard follow-up care with no light therapy intervention during the 4-week period.

Usual Care

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Linkou Chang Gung Memorial Hospital

Taoyuan District, 33305, Taiwan

Location

Related Publications (3)

  • Lin 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: 37797569BACKGROUND

  • Fox 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: 32080797BACKGROUND

  • Ozerdogan 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: 36154518BACKGROUND

Related Links

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersFatigue

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lingya Hsu, MSN, RN

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to either the bright light group or the dim red light control group in a parallel design. Each participant received only one type of light intervention throughout the study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2025

First Posted

August 20, 2025

Study Start

May 20, 2024

Primary Completion

November 27, 2024

Study Completion

March 7, 2025

Last Updated

August 20, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) that underlie the results reported in this article will be shared. The shared data will include the variables analyzed for primary and secondary outcomes, baseline characteristics, and adverse events (if applicable). Data will be available upon reasonable request to qualified researchers for the purpose of academic and non-commercial use. Interested researchers must provide a methodologically sound proposal and obtain approval from the principal investigator and the Institutional Review Board (IRB) of the host institution. Data will be available starting 6 months after publication of the study results and will remain available for up to 3 years. Requests for data sharing should be submitted to the corresponding author via email.

Shared Documents
STUDY PROTOCOL
Time Frame
IPD and supporting information will be available beginning 6 months after publication of the study results. Data will remain available for 3 years and may be extended upon request and approval by the principal investigator.
Access Criteria
Qualified researchers affiliated with academic or non-profit institutions may request access to individual participant data (IPD) and supporting documents (e.g., protocol, informed consent form, analytic code) for the purpose of scientific research. Requests must include a detailed research proposal and be submitted to the principal investigator for review and approval. Data will be de-identified to protect participant confidentiality, and access will be granted through a secure data sharing platform.

Locations

TW(1)