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

The Ohio State University

Status: Completed

Conditions: Acute Leukemia; Refractory Leukemia; Recurrent Leukemia

Treatments: Other: Survey Administration; Procedure: Bright White Light Therapy; Other: Best Practice

Study type: Interventional

Funder types: Other

Identifiers

NCT04597086

OSU-20091

NCI-2020-07234 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

Group I (BWLT, best practice)

Experimental group

Description:

Patients receive BWLT over 30 minutes in addition to standard of care daily during hospital stay.

Treatment:

Other: Survey Administration

Procedure: Bright White Light Therapy

Other: Best Practice

Group II (standard of care)

Active Comparator group

Description:

Patients receive standard of care during hospital stay.

Treatment:

Other: Survey Administration

Other: Best Practice