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Completed

NCT Number: NCT04597086

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

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.

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Key information

Conditions

Acute Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Neoplasms Neoplasms by Histologic Type Recurrent Leukemia Refractory Leukemia

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Best Practice

Other

Receive standard of care

Other names: standard of care, standard therapy

Bright White Light Therapy

Procedure

Receive BWLT

Survey Administration

Other

Ancillary studies

Primary outcomes

  1. Level of fatigue

    Time frame: 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 outcomes

  1. Sleep disturbance

    Time frame: Up to one month after discharge

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

  2. Anxiety

    Time frame: Up to one month after discharge

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

  3. Depression

    Time frame: Up to one month after discharge

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

  4. Distress

    Time frame: Up to one month after discharge

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

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 22, 2020
Registry last updated
Apr 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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