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| ID | Type | Description | Link |
|---|---|---|---|
| R21NR019892 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
| St. Jude Children's Research Hospital | OTHER |
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Children and adolescents treated for a brain tumor often experience fatigue and cognitive symptoms, such as slowed information processing and inattention. These symptoms may cause difficulty carrying out daily activities at home and at school. There are few well-researched, non-pharmacological interventions aimed at improving symptoms of fatigue and by extension cognitive symptoms. Systematic bright light exposure has been shown to improve symptoms of fatigue in adult survivors of cancer and children treated for some forms of cancer. This is a pilot/feasibility study and the first known study in children treated for a brain tumor. Findings from this study will be used to help plan a larger study to examine the effectiveness of this intervention and mechanisms of action.
PRIMARY OBJECTIVE:
To evaluate feasibility and adherence in a study of systematic bright light exposure used to improve fatigue and cognitive efficiency in survivors of pediatric brain tumor, including rates of enrollment, adherence, and acceptability.
SECONDARY OBJECTIVES:
To estimate the effect size of change in fatigue associated with bright light exposure.
To estimate the effect size of change in cognitive efficiency associated with bright light exposure.
Participants will be randomized to take part in one of two groups:
Participants will undergo the same evaluations and monitoring throughout the intervention and post-intervention follow-up. All participants will receive a pair of light glasses, with a phone app to track usage, and be fitted with an actigraph following consent to participate. Assessments will be completed at baseline (prior to intervention), with additional assessments at Week 4 (of intervention), Week 6 (end of intervention), and 2-weeks post-intervention (Week 8). Participants and their caregivers will complete questionnaires assessing fatigue, sleep, and mood. Psychological testing to measure attention, working memory, executive control, and processing speed will be completed using a computerized, online battery at each time point and in person at baseline and end of intervention. Caregivers will also be asked to complete a questionnaire about the family's general characteristics and medical history.
At baseline and end of intervention (Week 6), saliva will be collected. For each day of the intervention, participants will share their usage data and complete a daily sleep diary that includes time spent in bed, sleep/wake times, estimated amount of natural sunlight exposure, and medication use. A research coordinator will contact families on Days 2 and 5 and weekly thereafter for the duration of the intervention to identify possible light-related side effects and to check on compliance with light exposure (both frequency and duration). A remote app will be installed on the participant's or caregiver's cell phone to share light usage, which is tracked automatically once the device is turned on. At end of intervention (Week 6), participants and their caregivers will be asked to complete a short acceptability questionnaire.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bright Light Exposure | Active Comparator | Participants are exposed to bright light (1,000 lux at eye level) using light glasses (Luminette Version 3) for a maximum duration of 30 minutes upon awakening each day from Monday to Friday for 6 weeks while wearing an actigraph and periodic completion of questionnaires, cognitive assessments, and lab work. |
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| Dim Light Exposure | Placebo Comparator | Participants are exposed to exposed to dim light (equivalent intensity of <25 lux) using light glasses (Luminette) for a maximum duration of 30 minutes upon awakening each day from Monday to Friday for 6 weeks while wearing an actigraph and periodic completion of questionnaires, cognitive assessments, and lab work. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bright Light Exposure | Behavioral | Research coordinator will follow-up with participant on Days 2 & 5, and weekly thereafter to assess for the presence of potential side effects. If side effects are present with bright light initiation and they do not resolve by Day 5, the intervention will be discontinued. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of approached participants who consent to study participation | The rates of study participation and related 90% Blyth-Still-Casella intervals, as well as their regular 90% confidence interval, will be estimated. Test of one proportion will be performed against an estimated rate of 70%. The rate will be evaluated for the group as a whole as well as separately for the bright light intervention and placebo-control groups. | Once, prior to enrollment |
| Percent of sessions completed during all 6 weeks of bright or dim light exposure | The rates of light intervention adherence and related 90% Blyth-Still-Casella intervals, as well as their regular 90% confidence interval, will be estimated. Test of one proportion will be performed against an estimated rate of 77% of sessions completed on average. The rate will be evaluated for the group as a whole as well as separately for the bright light intervention and placebo-control groups. | At completion of bright or dim light exposure (Week 6) |
| Percent of participants rating the intervention as acceptable by indicating that they would recommend this intervention to other survivors. | The rates of completion of cognitive assessments and related 90% Blyth-Still-Casella intervals, as well as their regular 90% confidence interval, will be estimated. Test of one proportion will be performed against an estimated rate of 75%. The rate will be evaluated for the group as a whole as well as separately for the bright light intervention and placebo-control groups. | Once, at completion of intervention (Week 6) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fatigue outcome | For the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale, the raw score is converted to a standardized T-score (range 34-85) with a mean of 50 and standard deviation of 10, where a higher score represents greater severity of symptoms. The effect size (Cohen's d- the standardized difference between two means) of bright light exposure on fatigue will be estimated by comparing performance at baseline to that at Week 4 (comparison point in adult literature), using the paired difference divided by its estimated standard deviation. In addition, given potential for missing data, a mixed-effect model will be fit to investigate change in outcome from baseline to Week 4. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kimberly P Raghubar, PhD | Contact | 832-822-3713 | kpraghub@texaschildrens.org |
| Name | Affiliation | Role |
|---|---|---|
| Kimberly P Raghubar, PhD | Baylor College of Medicine | Principal Investigator |
| Heather M Conklin, PhD | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Children's Hospital | Recruiting | Houston | Texas | 77030 | United States |
The investigators will share de-identified data for all IPD that underlie results in a publication upon reasonable request.
6 months after publication.
Upon request to PI
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000073216 | Mental Status and Dementia Tests |
| D009483 | Neuropsychological Tests |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
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Randomized, double-blind, placebo-controlled trial design
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| Dim Light Exposure | Behavioral | A placebo pair of glasses that is identical in form to the bright light glasses with the exception of light intensity will be used in a manner identical to the bright light glasses. |
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| Cognitive Assessment | Other | Cognitive examinations will be completed in-person and remotely via an online platform; caregivers and participants will also be asked to complete questionnaires assessing fatigue, sleep, and mood. These outcomes will be completed at baseline (prior to intervention/placebo), Week 4, Week 6 (end of intervention/placebo), and Week 8 (2-weeks post intervention/placebo). |
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| Baseline (prior to start of intervention) compared to Week 4 (common length of intervention in adult literature) |
| Change in fatigue outcome | For the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale, the raw score is converted to a standardized T-score (range 34-85) with a mean of 50 and standard deviation of 10, where a higher score represents greater severity of symptoms. The effect size (Cohen's d- the standardized difference between two means) of bright light exposure on fatigue will be estimated by comparing performance at baseline to that at Week 6 (end of systematic light exposure), using the paired difference divided by its estimated standard deviation. In addition, given potential for missing data, a mixed-effect model will be fit to investigate change in outcome from baseline to Week 6. | Baseline (prior to start of intervention) compared to Week 6 (end of intervention) |
| Change in neurobehavioral outcome | Attention serves as the primary neurobehavioral endpoint, and it is measured by Omissions T-score (M = 50, SD = 10) from the Conners Continuous Performance Test, Third Edition (CPT-3), where higher scores indicate worse performance (<45 is low and 70+ is very elevated). The effect size (Cohen's d- the standardized difference between two means) of bright light exposure on attention will be estimated by comparing performance at baseline to that at Week 4 (comparison point in adult literature), using the paired difference divided by its estimated standard deviation. In addition, given potential for missing data, a mixed-effect model will be fit to investigate change in outcome from baseline to Week 4. | Baseline (prior to start of intervention) compared to Week 4 (common length of intervention in adult literature) |
| Change in neurobehavioral outcome | Attention serves as the primary neurobehavioral endpoint, and it is measured by Omissions T-score (M = 50, SD = 10) from the Conners Continuous Performance Test, Third Edition (CPT-3), where higher scores indicate worse performance (<45 is low and 70+ is very elevated). The effect size (Cohen's d- the standardized difference between two means) of bright light exposure on attention will be estimated by comparing performance at baseline to that at Week 6 (comparison point in adult literature), using the paired difference divided by its estimated standard deviation. In addition, given potential for missing data, a mixed-effect model will be fit to investigate change in outcome from baseline to Week 6. | Baseline (prior to start of intervention) compared to Week 6 (end of intervention) |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |