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

Primary Purpose

Cancer-related Fatigue, Light; Therapy, Complications

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
White Light Application
Sponsored by
Eskisehir Osmangazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer-related Fatigue focused on measuring Cancer-related fatigue, White light therapy, Chemotherapy, Clinical trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Eskisehir Osmangazi University Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

white light intervention group

Control group

Arm Description

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.

Outcomes

Primary Outcome Measures

White light changes general fatigue scores
White light changes general fatigue levels in patients with gynecological cancer

Secondary Outcome Measures

White light changes activity fatigue scores
White light changes activity fatigue levels in patients with gynecological cancer

Full Information

First Posted
August 2, 2021
Last Updated
August 11, 2021
Sponsor
Eskisehir Osmangazi University
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1. Study Identification

Unique Protocol Identification Number
NCT05009693
Brief Title
Effect of White Light on Fatigue Levels in Patients With Gynecological Cancer
Official Title
The Effect of White Light on Fatigue Levels in Patients With Gynecological Cancer: A Double Blind Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
June 20, 2020 (Actual)
Study Completion Date
June 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eskisehir Osmangazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer-related Fatigue, Light; Therapy, Complications
Keywords
Cancer-related fatigue, White light therapy, Chemotherapy, Clinical trial

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
white light intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
White Light Application
Intervention Description
White Light Therapy
Primary Outcome Measure Information:
Title
White light changes general fatigue scores
Description
White light changes general fatigue levels in patients with gynecological cancer
Time Frame
general fatigue levels of patients on 0., 9. and 21. days
Secondary Outcome Measure Information:
Title
White light changes activity fatigue scores
Description
White light changes activity fatigue levels in patients with gynecological cancer
Time Frame
activity fatigue levels of patients on 0., 9. and 21. days

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Eskisehir Osmangazi University Faculty of Medicine
City
Eskisehir
ZIP/Postal Code
26450
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Effect of White Light on Fatigue Levels in Patients With Gynecological Cancer

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