Acute Leukemia, Recurrent Leukemia, Refractory Leukemia
Conditions
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.
Interventions
OTHERBest Practice
Receive standard of care
PROCEDUREBright White Light Therapy
Receive BWLT
OTHERSurvey Administration
Ancillary studies
Sponsors
Ohio State University Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Sleep disturbance | Up to one month after discharge | Will be assessed by PROMIS-Sleep Disturbance. Will fit a mixed model. |
| Anxiety | Up to one month after discharge | Will be assessed by General Anxiety Disorder-7. Will fit a mixed model. |
| Depression | Up to one month after discharge | Will be assessed by Patient Health Questionnaire Depression Scale. Will fit a mixed model. |
| Distress | Up to one month after discharge | Will be assessed by Distress Thermometer. Will fit a mixed model. |
Countries
United States
Outcome results
None listed