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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Leukemia; Refractory Leukemia; Recurrent Leukemia
• Intervention / Treatment: Other: Survey Administration; Other: Best Practice; Procedure: Bright White Light Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: Shelly Brown, MS, APRN-CNS, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2020
• Primary Completion (Actual): January 13, 2023
• Study Completion (Actual): January 13, 2023

Study Registration Dates

• First Submitted: October 1, 2020
• First Submitted That Met QC Criteria: October 20, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: April 5, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia
• Other Study ID Numbers: OSU-20091; NCI-2020-07234 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No