Clincosm LogoSign in Get a demo

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

Sponsor
Ohio State University Comprehensive Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04597086
Collaborator
(none)
110
Enrollment
1
Location
2
Arms
27.5
Anticipated Duration (Months)
4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Best Practice
  • Procedure: Bright White Light Therapy
  • Other: Survey Administration
 N/A

Detailed Description

PRIMARY OBJECTIVE:
  1. To assess the efficacy of bright white light therapy (BWLT) on fatigue in patients diagnosed with leukemia during their hospitalization.
SECONDARY OBJECTIVES:

  1. To assess the efficacy of BWLT on sleep disturbance in patients diagnosed with leukemia during their hospitalization.

  2. To assess the efficacy of BWLT on anxiety in patients diagnosed with leukemia during their hospitalization.

  3. To assess the efficacy of BWLT on depression in patients diagnosed with leukemia during their hospitalization.

  4. 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 Design

Study Type:
Interventional
Anticipated Enrollment :
110 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
The Effects of Bright White Light Therapy on Fatigue, Sleep, Distress, Depression and Anxiety in the Hospitalized Leukemia Patient
Actual Study Start Date :
Sep 14, 2020
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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: Best Practice
Receive standard of care
Other Names:
  • standard of care
  • standard therapy

    • Procedure: Bright White Light Therapy
    Receive BWLT

    Other: Survey Administration
    Ancillary studies
    Active Comparator: Group II (standard of care)

    Patients receive standard of care during hospital stay.

    Other: Best Practice
    Receive standard of care
    Other Names:
  • standard of care
  • standard therapy

    • Other: Survey Administration
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Sleep disturbance [Up to one month after discharge]

      Will be assessed by PROMIS-Sleep Disturbance. Will fit a mixed model.

    2. Anxiety [Up to one month after discharge]

      Will be assessed by General Anxiety Disorder-7. Will fit a mixed model.

    3. Depression [Up to one month after discharge]

      Will be assessed by Patient Health Questionnaire Depression Scale. Will fit a mixed model.

    4. Distress [Up to one month after discharge]

      Will be assessed by Distress Thermometer. Will fit a mixed model.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210

    Sponsors and Collaborators

    • Ohio State University Comprehensive Cancer Center

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Shelly Brown, Principal Investigator, Ohio State University Comprehensive Cancer Center
    ClinicalTrials.gov Identifier:
    NCT04597086
    Other Study ID Numbers:
    • OSU-20091
    • NCI-2020-07234
    First Posted:
    Oct 22, 2020
    Last Update Posted:
    Oct 26, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Leukemia

    Study Results

    No Results Posted as of Oct 26, 2021