Light Therapy to Increase Energy in Adolescents and Young Adults Newly Diagnosed With Solid Tumors: A Pilot Study

Study Overview
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Brief Summary
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Fatigue is one of the most consistent and distressing symptoms reported by pediatric oncology patients. The investigators' work has demonstrated that in the period from diagnosis through the initial 8 weeks of treatment, adolescents and young adults with solid tumors experience substantial fatigue that is not related to sleep disruption. Fatigue can contribute to many adverse outcomes including poor treatment adherence, reduced social activities, depressive symptoms, behavior problems, and poorer quality of life. Unfortunately, no definitive intervention to reduce fatigue has been developed for pediatric oncology patients. Investigators propose a study to estimate the feasibility and acceptability of bright light therapy as an intervention to decrease fatigue in adolescents and young adults who are newly diagnosed and receiving treatment for solid tumors, including lymphoma.

Detailed Description
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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.

Official Title
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Light Therapy to Increase Energy in Adolescents and Young Adults Newly Diagnosed With Solid Tumors: A Pilot Study

Conditions
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Neoplasms, Fatigue

Intervention / Treatment
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* Other: Bright White Light
* Other: Dim Red Light


Participation Criteria
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Eligibility Criteria
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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])

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bright White Light<br>Participants use the bright white light intervention for 30 minutes upon waking each morning for 60 days. | Other: Bright White Light<br>* 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.<br>* Other names: BWL;|
| Experimental: Dim Red Light<br>Participants use the dim red light intervention for 30 minutes upon waking each morning for 60 days. | Other: Dim Red Light<br>* 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.<br>* Other names: DRL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of consent | 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 | Estimate the rates of adherence to the intervention in adolescent/young adult solid tumor or lymphoma patients for each group. | At the end of therapy (Day 60) | 
| Rate of side effects | Estimate rates of side effects in a light therapy intervention trial. | At the end of therapy (Day 60) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of fatigue | 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). | At the end of therapy (Day 60) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Solid Tumors