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

Primary Purpose

Acute Leukemia, Recurrent Leukemia, Refractory Leukemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Best Practice
Bright White Light Therapy
Survey Administration
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Leukemia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ohio State University Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group I (BWLT, best practice)

Group II (standard of care)

Arm Description

Patients receive BWLT over 30 minutes in addition to standard of care daily during hospital stay.

Patients receive standard of care during hospital stay.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Sleep disturbance
Will be assessed by PROMIS-Sleep Disturbance. Will fit a mixed model.
Anxiety
Will be assessed by General Anxiety Disorder-7. Will fit a mixed model.
Depression
Will be assessed by Patient Health Questionnaire Depression Scale. Will fit a mixed model.
Distress
Will be assessed by Distress Thermometer. Will fit a mixed model.

Full Information

First Posted
October 1, 2020
Last Updated
April 5, 2023
Sponsor
Ohio State University Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT04597086
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
September 14, 2020 (Actual)
Primary Completion Date
January 13, 2023 (Actual)
Study Completion Date
January 13, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Leukemia, Recurrent Leukemia, Refractory Leukemia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I (BWLT, best practice)
Arm Type
Experimental
Arm Description
Patients receive BWLT over 30 minutes in addition to standard of care daily during hospital stay.
Arm Title
Group II (standard of care)
Arm Type
Active Comparator
Arm Description
Patients receive standard of care during hospital stay.
Intervention Type
Other
Intervention Name(s)
Best Practice
Other Intervention Name(s)
standard of care, standard therapy
Intervention Description
Receive standard of care
Intervention Type
Procedure
Intervention Name(s)
Bright White Light Therapy
Intervention Description
Receive BWLT
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Level of fatigue
Description
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.
Time Frame
Up to one month after discharge
Secondary Outcome Measure Information:
Title
Sleep disturbance
Description
Will be assessed by PROMIS-Sleep Disturbance. Will fit a mixed model.
Time Frame
Up to one month after discharge
Title
Anxiety
Description
Will be assessed by General Anxiety Disorder-7. Will fit a mixed model.
Time Frame
Up to one month after discharge
Title
Depression
Description
Will be assessed by Patient Health Questionnaire Depression Scale. Will fit a mixed model.
Time Frame
Up to one month after discharge
Title
Distress
Description
Will be assessed by Distress Thermometer. Will fit a mixed model.
Time Frame
Up to one month after discharge

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shelly Brown, MS, APRN-CNS
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://cancer.osu.edu
Description
The Jamesline

Learn more about this trial

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

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