Acute LeukemiaNCT04597086
Bright White Light Therapy for the Improvement of Sleep, Fatigue, Distress, Depression, and Anxiety in Hospitalized Leukemia Patients
A study testing Best Practice, Bright White Light Therapy and Survey Administration in people with Acute Leukemia and Recurrent Leukemia, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Leukemia, Recurrent Leukemia, Refractory Leukemia
- What is being tested?
- Best Practice, Bright White Light Therapy and Survey Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2020to 13 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: The Effects of Bright White Light Therapy on Fatigue, Sleep, Distress, Depression and Anxiety in the Hospitalized Leukemia Patient
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To assess the efficacy of bright white light therapy (BWLT) on fatigue in patients diagnosed with leukemia during their hospitalization.
SECONDARY OBJECTIVES:
- To assess the efficacy of BWLT on sleep disturbance in patients diagnosed with leukemia during their hospitalization.
- 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
- Acute Leukemia, Recurrent Leukemia, Refractory Leukemia
- Being tested
- Best Practice, Bright White Light Therapy, Survey Administration
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive standard of care
Bright White Light TherapyProcedure or surgery
Receive BWLT
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Group I (BWLT, best practice) | Experimental | Patients receive BWLT over 30 minutes in addition to standard of care daily during hospital stay. Receives: Other: Best Practice; Procedure: Bright White Light Therapy; Other: Survey Administration |
| Group II (standard of care) | Active comparator | Patients receive standard of care during hospital stay. Receives: Other: Best Practice; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to one month after discharge
Secondary outcomes (4)
Sleep disturbance
Will be assessed by PROMIS-Sleep Disturbance. Will fit a mixed model.
Measured: Up to one month after discharge
Anxiety
Will be assessed by General Anxiety Disorder-7. Will fit a mixed model.
Measured: Up to one month after discharge
Depression
Will be assessed by Patient Health Questionnaire Depression Scale. Will fit a mixed model.
Measured: Up to one month after discharge
Distress
Will be assessed by Distress Thermometer. Will fit a mixed model.
Measured: Up to one month after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start14 Sep 2020
- Primary completion13 Jan 2023
- Study completion13 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute LeukemiaStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shelly Brown, Ohio State University Comprehensive Cancer Center
- Investigators
- Shelly Brown, MS, APRN-CNS, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04597086
- Sponsor's protocol ID
- OSU-20091
- Other IDs
- NCI-2020-07234
- Status last verified
- Apr 2023
- First submitted
- 1 Oct 2020
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Bright White Light Therapy on Fatigue, Sleep, Distress, Depression and Anxiety in the Hospitalized Leukemia Patient
- ClinicalTrials.gov ID
- NCT04597086
- Acronym / sponsor ID
- OSU-20091
- Conditions
- Acute Leukemia, Recurrent Leukemia, Refractory Leukemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 13 Jan 2023 (actual)
- Study completion
- 13 Jan 2023 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To assess the efficacy of bright white light therapy (BWLT) on fatigue in patients diagnosed with leukemia during their hospitalization.
SECONDARY OBJECTIVES:
- To assess the efficacy of BWLT on sleep disturbance in patients diagnosed with leukemia during their hospitalization.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (BWLT, best practice) | Experimental | Other: Best Practice, Procedure: Bright White Light Therapy, Other: Survey AdministrationPatients receive BWLT over 30 minutes in addition to standard of care daily during hospital stay. |
| Group II (standard of care) | Active comparator | Other: Best Practice, Other: Survey AdministrationPatients receive standard of care during hospital stay. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- Current eye disorders which is defined as:
- Diagnosed bipolar disorder
- Persons with pacemakers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive standard of care | Other | Group I (BWLT, best practice), Group II (standard of care) |
| Bright White Light TherapyReceive BWLT | Procedure or surgery | Group I (BWLT, best practice) |
| Survey AdministrationAncillary studies | Other | Group I (BWLT, best practice), Group II (standard of care) |
Primary outcome
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.
4 secondary outcomes
Sleep disturbance
Time frame: Up to one month after discharge
Anxiety
Time frame: Up to one month after discharge
Depression
Time frame: Up to one month after discharge
Distress
Time frame: Up to one month after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shelly Brown, MS, APRN-CNS principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Bright White Light Therapy and Survey Administration in people with Acute Leukemia and Recurrent Leukemia, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of fatigue (time frame: Up to one month after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.