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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. 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.
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
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Linkou Chang Gung Memorial Hospital
Taoyuan District, Taiwan
Start Date
May 20, 2024
Primary Completion Date
November 27, 2024
Completion Date
March 7, 2025
Last Updated
August 20, 2025
94
ACTUAL participants
Re-Timer® light therapy glasses
DEVICE
Usual Care
OTHER
Lead Sponsor
Chang Gung Memorial Hospital
Collaborators
NCT06082518
NCT05742776
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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