Brain Tumor Clinical Trial
— SLEPBTOfficial title:
Systematic Light Exposure Intervention for Fatigue and Cognitive Efficiency in Pediatric Brain Tumor Survivors
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: 1. 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: 2. To estimate the effect size of change in fatigue associated with bright light exposure. 3. To estimate the effect size of change in cognitive efficiency associated with bright light exposure.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | March 2025 |
Est. primary completion date | February 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years to 18 Years |
Eligibility | Inclusion Criteria: - Diagnosed and treated for a brain tumor at Texas Children's Hospital - Treated with either surgery only or surgery and proton beam radiation therapy - Treated for tumors other than high-grade gliomas, brain stem gliomas, or atypical teratoid rhabdoid tumors given associated reduced survival rates - Currently or previously enrolled in longitudinal studies of neurocognitive outcomes in survivors of pediatric brain tumor (Lisa Kahalley, PI; H-29026, H-35681, H-40804, H-40961, H-49380, H-26785, H-41705 - Ages 10-18 years - At least 1 year post-diagnosis - Endorsed mild to moderate symptoms of fatigue on the PROMIS - Approval from Long-Term Survivorship provider - Adequate vision for computerized tasks - English-speaking - Intelligence Quotient (IQ) above 70 Exclusion Criteria: - Diagnosis and/or treatment for secondary malignancy in the past 12 months - Current or previous (within 12 months) suicidal ideation or severe depression requiring immediate intervention - Presence of photophobia or other eye diseases, seizures, and/or migraines - Use of photosensitizing medications - Current or previous use of light therapy |
Country | Name | City | State |
---|---|---|---|
United States | Texas Children's Hospital | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Baylor College of Medicine | National Institute of Nursing Research (NINR), St. Jude Children's Research Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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) | |
Primary | 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) | |
Secondary | 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. | Baseline (prior to start of intervention) compared to Week 4 (common length of intervention in adult literature) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) |
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