Clinical trial NCT04597086: Bright White Light Therapy for the Improvement of Sleep, Fatigue, Distress, Depression, and Anxiety in Hospitalized Leukemia Patients
Official title: The Effects of Bright White Light Therapy on Fatigue, Sleep, Distress, Depression and Anxiety in the Hospitalized Leukemia Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Leukemia
Recurrent Leukemia
Refractory Leukemia
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 74
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Level of fatigue
timeFrame: Up to one month after discharge
Secondary outcomes:
measure: Sleep disturbance
timeFrame: Up to one month after discharge
measure: Anxiety
timeFrame: Up to one month after discharge
measure: Depression
timeFrame: Up to one month after discharge
measure: Distress
timeFrame: Up to one month after discharge
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Shelly Brown, MS, APRN-CNS
role: PRINCIPAL_INVESTIGATOR
References: