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

Not Applicable

Completed

• Conditions: Recurrent Leukemia; Acute Leukemia; Refractory Leukemia
• Interventions: Other: Best Practice; Other: Survey Administration; Procedure: Bright White Light Therapy

• Registration Number: NCT04597086
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

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.

Study Timeline

• Study Start: 2020-09-14
• Study First Submitted: 2020-10-01
• Study First Submitted QC: 2020-10-20
• Study First Posted: 2020-10-22
• Primary Completion: 2023-01-13
• Study Completion: 2023-01-13
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-05
• Last Update Posted: 2023-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II (standard of care)	Survey Administration	Patients receive standard of care during hospital stay.
Group II (standard of care)	Best Practice	Patients receive standard of care during hospital stay.
Group I (BWLT, best practice)	Best Practice	Patients receive BWLT over 30 minutes in addition to standard of care daily during hospital stay.
Group I (BWLT, best practice)	Bright White Light Therapy	Patients receive BWLT over 30 minutes in addition to standard of care daily during hospital stay.
Group I (BWLT, best practice)	Survey Administration	Patients receive BWLT over 30 minutes in addition to standard of care daily during hospital stay.

Primary Outcome Measures

Name	Time	Method
Level of fatigue	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 Outcome Measures

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

Trial Locations

Locations (1)

Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States