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
• 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
• 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

Related Conditions & MeSH terms

• Acute Leukemia
• Leukemia
• Recurrent Leukemia
• Refractory Leukemia

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

External Links

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