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Clinical Trials/NCT04597086
NCT04597086
Completed
Not Applicable

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

Ohio State University Comprehensive Cancer Center1 site in 1 country74 target enrollmentSeptember 14, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Leukemia
Sponsor
Ohio State University Comprehensive Cancer Center
Enrollment
74
Locations
1
Primary Endpoint
Level of fatigue
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 14, 2020
End Date
January 13, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Shelly Brown

Principal Investigator

Ohio State University Comprehensive Cancer Center

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

Outcomes

Primary Outcomes

Level of fatigue

Time Frame: Up to one month after discharge

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.

Secondary Outcomes

  • Anxiety(Up to one month after discharge)
  • Sleep disturbance(Up to one month after discharge)
  • Distress(Up to one month after discharge)
  • Depression(Up to one month after discharge)

Study Sites (1)

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