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

NCT ID: NCT04597086

Last Updated: 2023-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-14

Study Completion Date

2023-01-13

Brief Summary

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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

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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.

Conditions

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Acute Leukemia Recurrent Leukemia Refractory Leukemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Group I (BWLT, best practice)

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

Group Type EXPERIMENTAL

Best Practice

Intervention Type OTHER

Receive standard of care

Bright White Light Therapy

Intervention Type PROCEDURE

Receive BWLT

Survey Administration

Intervention Type OTHER

Ancillary studies

Group II (standard of care)

Patients receive standard of care during hospital stay.

Group Type ACTIVE_COMPARATOR

Best Practice

Intervention Type OTHER

Receive standard of care

Survey Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Best Practice

Receive standard of care

Intervention Type OTHER

Bright White Light Therapy

Receive BWLT

Intervention Type PROCEDURE

Survey Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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standard of care standard therapy

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Shelly Brown

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shelly Brown, MS, APRN-CNS

Role: PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Locations

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Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Related Links

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Other Identifiers

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NCI-2020-07234

Identifier Type: REGISTRY

Identifier Source: secondary_id

OSU-20091

Identifier Type: -

Identifier Source: org_study_id

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