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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-07234 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (BWLT, best practice) | Experimental | Patients receive BWLT over 30 minutes in addition to standard of care daily during hospital stay. |
|
| Group II (standard of care) | Active Comparator | Patients receive standard of care during hospital stay. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Receive standard of care |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to one month after discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep disturbance | Will be assessed by PROMIS-Sleep Disturbance. Will fit a mixed model. | Up to one month after discharge |
| Anxiety | Will be assessed by General Anxiety Disorder-7. Will fit a mixed model. |
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Inclusion Criteria:
Exclusion Criteria:
Current eye disorders which is defined as:
Diagnosed bipolar disorder
Persons with pacemakers
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| Name | Affiliation | Role |
|---|---|---|
| Shelly Brown, MS, APRN-CNS | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 17, 2019 | Feb 27, 2023 |
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| Bright White Light Therapy | Procedure | Receive BWLT |
|
| Survey Administration | Other | Ancillary studies |
|
| Up to one month after discharge |
| Depression | Will be assessed by Patient Health Questionnaire Depression Scale. Will fit a mixed model. | Up to one month after discharge |
| Distress | Will be assessed by Distress Thermometer. Will fit a mixed model. | Up to one month after discharge |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| D014467 | Ultraviolet Therapy |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
| D010789 | Phototherapy |
| D013812 | Therapeutics |
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