- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02429063
Light Therapy to Increase Energy in Adolescents and Young Adults Newly Diagnosed With Solid Tumors: A Pilot Study
Study Overview
Status
Intervention / Treatment
Detailed Description
This feasibility and acceptability study will assess the rate of consent to, adherence to, and side effects from a therapy study in a randomized trial comparing bright white light (BWL) to dim red light (DRL). Four questionnaires will be distributed to patients and/or their parents, depending upon the questionnaire, to study the fatigue, quality of life, mood symptoms, and side effects of the BWL/DRL intervention in adolescents and young adults being treated for solid tumors, including lymphoma.
PRIMARY OBJECTIVES:
- To estimate the feasibility and acceptability of a BWL intervention compared to a DRL standard comparison group in adolescent/young adult solid tumor and lymphoma patients.
SECONDARY OBJECTIVE:
- To estimate the effect size of this intervention on measures of fatigue in order to design a larger clinical trial of efficacy of a randomized control trial of BWL versus DRL intervention for fatigue in pediatric oncology patients.
OTHER PRESPECIFIED OBJECTIVES:
- Estimate the effect of participant location (inpatient, hospital-based housing, or home) on adherence.
- Estimate rates of depressive symptoms.
- Describe quality of life.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Tennessee
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Memphis, Tennessee, United States, 38105
- St . Jude Children's Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
INCLUSION CRITERIA:
- Age 12 years or older
- Has initiated treatment as part of an active St. Jude Children's Research Hospital (SJCRH) treatment plan
- ≤ 30 days post diagnosis of a solid tumor or lymphoma
- Patient speaks, reads and writes in English or Spanish
- Potential participant/guardian is willing to sign informed consent
EXCLUSION CRITERIA:
- Blind or having a history of eye disease including, but not limited to, macular degeneration, or other diagnosed retinal problems
- Undergone laser corrective eye surgery in the past 30 days
- Significant physiological or psychological impairment that interferes with participation (e.g., migraines, bipolar disorder, psychosis, seasonal affective disorder)
- Recently started on anti-depressant medications (past one month for those on Selective Serotonin Reuptake Inhibitors [SSRI] and past two months for those started on Monoamine Oxidase Inhibitors [MAOI])
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bright White Light
Participants use the bright white light intervention for 30 minutes upon waking each morning for 60 days.
|
The light will be administered via a Litebook Elite or Litebook Advantage (Litebook®, Ltd., Medicine Hat, Canada).
The Litebook® is a small (6×5×1 in.) and lightweight (8 oz.) box and will be fitted with adherence monitors to record at what time and for what duration the light box is turned on.
The Litebook® is designed to be placed on a table approximately 18 inches from the participant's head and within 45° of the midline of the visual field.
The BWL Litebook® looks identical to the DRL and utilizes 24 white light-emitting diode (LED) lights and does not emit ultraviolet light.
Other Names:
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Experimental: Dim Red Light
Participants use the dim red light intervention for 30 minutes upon waking each morning for 60 days.
|
The light will be administered via a Litebook Elite or Litebook Advantage (Litebook®, Ltd., Medicine Hat, Canada).
The Litebook® is a small (6×5×1 in.) and lightweight (8 oz.) box and will be fitted with adherence monitors to record at what time and for what duration the light box is turned on.
The Litebook® is designed to be placed on a table approximately 18 inches from the participant's head and within 45° of the midline of the visual field.
The DRL Litebook looks identical to the BWL box and contains red lights rather than white LED lights.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of consent
Time Frame: Day 0
|
Estimate the rates of consent to a BWL intervention, compared to DRL in adolescent/young adult solid tumor and lymphoma patients.
|
Day 0
|
Rate of adherence
Time Frame: At the end of therapy (Day 60)
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Estimate the rates of adherence to the intervention in adolescent/young adult solid tumor or lymphoma patients for each group.
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At the end of therapy (Day 60)
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Rate of side effects
Time Frame: At the end of therapy (Day 60)
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Estimate rates of side effects in a light therapy intervention trial.
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At the end of therapy (Day 60)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of fatigue
Time Frame: At the end of therapy (Day 60)
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Estimate the rates of fatigue between the intervention and comparison groups.
Fatigue will be measured by self- and parent-report with the 18-item PedsQL™ Multidimensional Fatigue Scale (MFS) that includes three subscales: (1) general fatigue (six items), (2) sleep/rest fatigue (six items), and (3) cognitive fatigue (six items).
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At the end of therapy (Day 60)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of adherence by participant location
Time Frame: At the end of therapy (Day 60)
|
Estimate the effect of participant location (inpatient, hospital-based housing, or home) on adherence.
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At the end of therapy (Day 60)
|
Rate of depressive symptoms
Time Frame: Baseline (Day 0), and approximately Day 14, Day 28 Day 42, and Day 60
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Mood symptoms will be assessed with the Children's Depression Inventory, 2nd Edition (CDI 2) in participants 8-17 years old and by the BDI-II in participants 18 years of age and older.
The CDI 2 is a 27-item self-report measure of depressive symptoms in children ages 7-17.
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Baseline (Day 0), and approximately Day 14, Day 28 Day 42, and Day 60
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Metrics of quality of life and well-being
Time Frame: Baseline (Day 0), and approximately Day 14, Day 28, Day 42, and Day 60
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Quality of life will be assessed by self- and parent-report with the PedsQL™ Acute Version [34] that includes 4 subscales: (1) physical functioning (eight items), (2) emotional functioning (five items), (3) social functioning (five items), and (4) school functioning (five items) as well as a total score.
The Likert scale and scoring method are identical to the MFS, with higher scores indicating better health-related quality of life.
The PedsQL™ will be completed prior to initiation of the intervention, at three time points during the intervention period (14 +/- 3, 28 +/- 3 days, and 42 +/- 3 days) , and at the end of the 60 day intervention/period (days 61-68).
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Baseline (Day 0), and approximately Day 14, Day 28, Day 42, and Day 60
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LITE
- NCI-2015-00679 (Registry Identifier: NCI Clinical Trial Registration Program)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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