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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Acute Leukemia, Recurrent Leukemia, Refractory Leukemia

Intervention / Treatment
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* Other: Best Practice
* Procedure: Bright White Light Therapy
* Other: Survey Administration


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (BWLT, best practice)<br>Patients receive BWLT over 30 minutes in addition to standard of care daily during hospital stay. | Other: Best Practice<br>* Receive standard of care<br>* Other names: standard therapy;Procedure: Bright White Light Therapy<br>* Receive BWLT<br>Other: Survey Administration<br>* Ancillary studies<br>|
| Active Comparator: Group II (standard of care)<br>Patients receive standard of care during hospital stay. | Other: Best Practice<br>* Receive standard of care<br>* Other names: standard therapy;Other: Survey Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep disturbance | Will be assessed by PROMIS-Sleep Disturbance. Will fit a mixed model. | Up to one month after discharge | 
| Anxiety | Will be assessed by General Anxiety Disorder-7. Will fit a mixed model. | Up to one month after discharge | 
| Depression | Will be assessed by Patient Health Questionnaire Depression Scale. Will fit a mixed model. | Up to one month after discharge | 
| Distress | Will be assessed by Distress Thermometer. Will fit a mixed model. | Up to one month after discharge |