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
2 other identifiers
interventional
74
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 14, 2020
CompletedFirst Submitted
Initial submission to the registry
October 1, 2020
CompletedFirst Posted
Study publicly available on registry
October 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 13, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 13, 2023
CompletedApril 7, 2023
April 1, 2023
2.3 years
October 1, 2020
April 5, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Sleep disturbance
Up to one month after discharge
Anxiety
Up to one month after discharge
Depression
Up to one month after discharge
Distress
Up to one month after discharge
Study Arms (2)
Group I (BWLT, best practice)
EXPERIMENTALPatients receive BWLT over 30 minutes in addition to standard of care daily during hospital stay.
Group II (standard of care)
ACTIVE COMPARATORPatients receive standard of care during hospital stay.
Interventions
Receive standard of care
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shelly Brown, MS, APRN-CNS
Ohio State University Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 1, 2020
First Posted
October 22, 2020
Study Start
September 14, 2020
Primary Completion
January 13, 2023
Study Completion
January 13, 2023
Last Updated
April 7, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share