Gynecologic Cancer SurvivorsNCT07132580
Effects of Bright Light on Sleep Quality, Fatigue , and Mood Symptoms in Survivors With Gynecologic Cancer
A study testing Re-Timer® light therapy glasses in people with Gynecologic Cancer Survivors and Sleep Quality, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Cancer Survivors, Sleep Quality, Fatigue
- What is being tested?
- Re-Timer® light therapy glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 May 2024to 7 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Bright Light Therapy on Sleep Quality, Cancer-Related Fatigue, and Emotional Symptoms in Gynecologic Cancer Survivors: A Randomized Controlled Trial
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.
Read more
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.
Read the detailed description
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
This is a randomized, controlled, single-blind trial with a parallel-group design. Eligible participants will be randomly assigned in a 1:1 ratio to either the intervention group (BLT) or the control group. Outcome assessors will remain blinded to group allocation throughout the study.
Intervention
Participants in the intervention group will receive bright light therapy using Re-Timer® light therapy glasses, which emit green-blue light at an intensity of 506 lux. Participants will be instructed to wear the glasses for 45 minutes each morning over four consecutive weeks. Sessions are self-administered at home between 7:00 AM and 9:00 AM, based on circadian rhythm guidance.
Control Condition
The control group will receive usual care and will not be provided with any light therapy. Participants in this group will be instructed to maintain their typical daily routines and avoid introducing new interventions that could impact sleep or mood during the study period.
Outcome Measures and Timepoints
Outcome data will be collected through an online questionnaire via the LINE messaging app at the following timepoints:
T1: Day 7 of intervention
T2: Day 14 of intervention
T3: Day 21 of intervention
T4: Day 28 of intervention
The following instruments will be used:
Insomnia Severity Index - Chinese version (ISI-C): to assess insomnia symptoms
Brief Fatigue Inventory - Taiwanese version (BFI-T): to assess cancer-related fatigue
Distress Thermometer (DT): to assess emotional distress
- Conditions
- Gynecologic Cancer Survivors, Sleep Quality, Fatigue, Mood Symptoms
- Being tested
- Re-Timer® light therapy glasses, Usual Care
- Keywords
- light therapy, gynecologic cancer, chemotherapy, sleep quality, fatigue, emotional symptoms
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Usual CareOther
Participants received standard follow-up care with no light therapy intervention during the 4-week period.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 7 (T1), Day 14 (T2), Day 21 (T3), and Day 28 (T4) after intervention start.
Secondary outcomes (2)
Cancer-related fatigue (BFI-T)
To assess the level of cancer-related fatigue using the Brief Fatigue Inventory - Traditional Chinese version (BFI-T).
The BFI-T includes 9 items rated on a 0-10 numeric scale, with higher scores indicating greater fatigue severity and interference.
Measured: Day 7 (T1), Day 14 (T2), Day 21 (T3), and Day 28 (T4) after the start of the intervention.
Emotional distress (Distress Thermometer, DT)
To measure overall emotional distress using the Distress Thermometer (DT), a single-item visual analog scale ranging from 0 (no distress) to 10 (extreme distress).
Participants indicate their distress levels during the past week.
Measured: Day 7 (T1), Day 14 (T2), Day 21 (T3), and Day 28 (T4) after the start of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start20 May 2024
- Primary completion27 Nov 2024
- Study completion7 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gynecologic Cancer SurvivorsStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taipei University of Nursing and Health Sciences
- Responsible party
- Sponsor
- Investigators
- Lingya Hsu, MSN, RN, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07132580
- Sponsor's protocol ID
- 202400345A3C601
- Other IDs
- IRB Protocol ID
- Status last verified
- Aug 2025
- First submitted
- 10 Aug 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 37797569Fox 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.
PubMed 32080797Ozerdogan 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.
PubMed 36154518
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bright Light Therapy on Sleep Quality, Cancer-Related Fatigue, and Emotional Symptoms in Gynecologic Cancer Survivors: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07132580
- Acronym / sponsor ID
- 202400345A3C601
- Conditions
- Gynecologic Cancer Survivors, Sleep Quality, Fatigue, Mood Symptoms
- Keywords
- light therapy, gynecologic cancer, chemotherapy, sleep quality, fatigue, emotional symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- National Taipei University of Nursing and Health Sciences
- Study start
- 20 May 2024 (actual)
- Primary completion
- 27 Nov 2024 (actual)
- Study completion
- 7 Mar 2025 (actual)
- First posted
- 20 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
This is a randomized, controlled, single-blind trial with a parallel-group design. Eligible participants will be randomly assigned in a 1:1 ratio to either the intervention group (BLT) or the control group. Outcome assessors will remain blinded to group allocation throughout the study.
Intervention
Participants in the intervention group will receive bright light therapy using Re-Timer® light therapy glasses, which emit green-blue light at an intensity of 506 lux. Participants will be instructed to wear the glasses for 45 minutes each morning over four consecutive weeks. Sessions are self-administered at home between 7:00 AM and 9:00 AM, based on circadian rhythm guidance.
Control Condition
The control group will receive usual care and will not be provided with any light therapy. Participants in this group will be instructed to maintain their typical daily routines and avoid introducing new interventions that could impact sleep or mood during the study period.
Outcome Measures and Timepoints
Outcome data will be collected through an online questionnaire via the LINE messaging app at the following timepoints:
T1: Day 7 of intervention
T2: Day 14 of intervention
T3: Day 21 of intervention
T4: Day 28 of intervention
The following instruments will be used:
Insomnia Severity Index - Chinese version (ISI-C): to assess insomnia symptoms
Brief Fatigue Inventory - Taiwanese version (BFI-T): to assess cancer-related fatigue
Distress Thermometer (DT): to assess emotional distress
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Bright Light Intervention Group | Experimental | Device: Re-Timer® light therapy glassesParticipants 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. |
| Usual Care | Other | Other: Usual CareParticipants in this group received usual care and did not receive any light therapy intervention during the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Re-Timer® light therapy glassesParticipants wore Re-Timer® glasses that emitted bright white light at 506 lux for 30 minutes each morning, over a 4-week intervention period. | Device | Bright Light Intervention Group |
| Usual CareParticipants received standard follow-up care with no light therapy intervention during the 4-week period. | Other | Usual Care |
Primary outcome
Change in Insomnia Severity Index - Chinese version (ISI-C)
Time frame: 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.
2 secondary outcomes
Cancer-related fatigue (BFI-T)
Time frame: Day 7 (T1), Day 14 (T2), Day 21 (T3), and Day 28 (T4) after the start of the intervention.
Emotional distress (Distress Thermometer, DT)
Time frame: Day 7 (T1), Day 14 (T2), Day 21 (T3), and Day 28 (T4) after the start of the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Background: PubMed 37797569Lin 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.
- Background: PubMed 32080797Fox 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.
- Background: PubMed 36154518Ozerdogan 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.
- Cancer Statistics - Ministry of Health and Welfare TaiwanLink provided by the sponsor.
- NCCN Distress Thermometer - Traditional ChineseLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lingya Hsu, MSN, RN principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Re-Timer® light therapy glasses in people with Gynecologic Cancer Survivors and Sleep Quality, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Insomnia Severity Index - Chinese version (ISI-C) (time frame: Day 7 (T1), Day 14 (T2), Day 21 (T3), and Day 28 (T4) after intervention start.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07132580, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.