Effect of White Light on Fatigue Levels in Patients With Gynecological Cancer

Study Overview
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Brief Summary
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White light therapy is one of the non-pharmacological methods in the management of fatigue. Cancer-related fatigue (CRF) is a persistent, subjective sense of physical, emotional, and/or cognitive tiredness or burnout. It is associated with cancer or cancer treatment from the first diagnosis until the end of life that is not proportional to recent physical activity. It was founded that 10,000 Lux bright white light administered in the morning hours reduced fatigue by 17% in patients with cancer and that the mean fatigue scores of patients decreased from 30.37 to 9.48 compared to before the light administration. According to NCCN (2020), white light of 10,000 Lux can be applied for 30-90 minutes in the morning hours to regulate sleep and manage fatigue in the post treatment period as well as in cancer patients receiving active treatment. However, studies on this subject consist of small sample groups, and more studies are needed to identify the risks and benefits of the application and to determine the optimal application time and duration. The present study was aimed to evaluate the effect of white light on the fatigue levels of patients with gynecological cancer who were treated with chemotherapy. The patients with high levels of fatigue in every dimension were selected so as to have a homogeneous group. The research hypotheses were determined as follows: H0: White light has no effect on fatigue levels in patients with gynecological cancer. H1: White light reduces fatigue levels in patients with gynecological cancer.

Official Title
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The Effect of White Light on Fatigue Levels in Patients With Gynecological Cancer: A Double Blind Randomized Trial

Conditions
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Cancer-related Fatigue, Light; Therapy, Complications

Intervention / Treatment
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* Other: White Light Application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: had a normal state of consciousness, had no communication disorders, did not work in the night shift, had a general fatigue level score of ≥1 according to the Brief Fatigue Inventory Exclusion Criteria: had natural/artificial lenses, used medication that causes photosensitivity (tetracycline, doxycycline, nalidixic acid, voriconazole, amiodarone, hydrochlorothiazide, naproxen, piroxicam, chlorpromazine) had a change in their treatment plan in the last 6 weeks were not included in the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: white light intervention group<br>Between the second and the eighth days of the application phase, the patients in the intervention group were administered a standard white light at 10,000 Lux intensity by an independent nurse (RA1) in their home environment using a Litebook Elite light source (The Litebook Company Ltd., Medicine Hat, AB). The distance between the light source and the patient's face was set at 50 cm, and the intensity of the light for each patient was checked using a Lux Meter. The intervention was applied between 07:00 and 10:00 in the morning for 30 minutes without interruption, and it was continued for seven successive days. The light application procedure was followed based on the previous studies on oncology patients. The second and third evaluations of the fatigue status of patients were completed on the 9th and 21st days. | Other: White Light Application<br>* White Light Therapy<br>|
| No Intervention: Control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| White light changes general fatigue scores | White light changes general fatigue levels in patients with gynecological cancer | general fatigue levels of patients on 0., 9. and 21. days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| White light changes activity fatigue scores | White light changes activity fatigue levels in patients with gynecological cancer | activity fatigue levels of patients on 0., 9. and 21. days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer-related fatigue, White light therapy, Chemotherapy, Clinical trial