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NCT04597086 Clinical Trial

Bright White Light Therapy for the Improvement of Sleep, Fatigue, Distress, Depression, and Anxiety in Hospitalized Leukemia Patients

Acute Leukemia Clinical Trial

Official title:
The Effects of Bright White Light Therapy on Fatigue, Sleep, Distress, Depression and Anxiety in the Hospitalized Leukemia Patient

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04597086
Other study ID # OSU-20091
Secondary ID NCI-2020-07234
Status Completed
Phase N/A
First received
Last updated
Start date September 14, 2020
Est. completion date January 13, 2023

Study information
Verified date April 2023
Source Ohio State University Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial investigates how well bright white light therapy works in improving sleep, fatigue, distress, depression, and anxiety, side effects that are often experienced during an intense leukemia treatment regimen, in hospitalized leukemia patients. Bright white light therapy may help to control these symptoms, and information from this study may help doctors and nurses learn more about methods for decreasing these symptoms.

Description:

PRIMARY OBJECTIVE: I. To assess the efficacy of bright white light therapy (BWLT) on fatigue in patients diagnosed with leukemia during their hospitalization. SECONDARY OBJECTIVES: I. To assess the efficacy of BWLT on sleep disturbance in patients diagnosed with leukemia during their hospitalization. I. To assess the efficacy of BWLT on anxiety in patients diagnosed with leukemia during their hospitalization. III. To assess the efficacy of BWLT on depression in patients diagnosed with leukemia during their hospitalization. IV. To assess the efficacy of BWLT on distress in patients diagnosed with leukemia during their hospitalization. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients receive BWLT over 30 minutes in addition to standard of care daily during hospital stay. GROUP II: Patients receive standard of care during hospital stay.

Recruitment information / eligibility
Status Completed
Enrollment 74
Est. completion date January 13, 2023
Est. primary completion date January 13, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Admitted to the Acute Leukemia Unit for an anticipated stay of 3 weeks or longer - English speaking - Able to comprehend and sign a consent form - Able to read and complete surveys - Alert and oriented - Without BWLT for seven days prior to initiating the trial Exclusion Criteria: - Current eye disorders which is defined as: - Iritis, uveitis, keratitis, cataract, glaucoma, macular degeneration, retinal detachment, or retinitis pigmentosa - Diagnosed bipolar disorder - Persons with pacemakers - The manufacturer of the BWLT unit used for this study mentions the light unit contains magnets

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Best Practice
Receive standard of care
Procedure:
• Bright White Light Therapy
Receive BWLT
Other:
• Survey Administration
Ancillary studies

Locations
Country Name City State
United States Ohio State University Comprehensive Cancer Center Columbus Ohio

Sponsors (1)
Lead Sponsor Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Level of fatigue Will be assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue. Will fit a mixed model of fatigue as a function of time and group. Up to one month after discharge
Secondary Sleep disturbance Will be assessed by PROMIS-Sleep Disturbance. Will fit a mixed model. Up to one month after discharge
Secondary Anxiety Will be assessed by General Anxiety Disorder-7. Will fit a mixed model. Up to one month after discharge
Secondary Depression Will be assessed by Patient Health Questionnaire Depression Scale. Will fit a mixed model. Up to one month after discharge
Secondary Distress Will be assessed by Distress Thermometer. Will fit a mixed model. Up to one month after discharge
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