The Light for the Brain Study

Study Overview
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Brief Summary
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Cognitive impairment (such as memory problems) due to cancer and its treatment can interfere with quality of life and can linger long after treatment has ended, yet research examining cognitive rehabilitation approaches has produced limited clinical benefit. The proposed study will provide information about systematic light exposure for the treatment of cognitive impairment in hematopoietic stem cell transplant (HSCT) survivors and will investigate how it works. This study would facilitate the development of this potential treatment, giving health care providers and cancer survivors a much-needed tool to help with cancer-related cognitive impairment.

Official Title
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Treating Cognitive Impairments in Cancer Patients Via Systematic Light Exposure

Conditions
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Hematopoietic Stem Cell Transplantation, Cognitive Impairments, Sleep, Depression, Fatigue, Quality of Life

Intervention / Treatment
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* Device: Intervention systematic light exposure
* Device: Comparison systematic light exposure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a history of HSCT, 1 to 5 years post-HSCT, Relapse-free since most recent HSCT, Age 21 or older, English language proficient Able to provide informed consent Endorse subjective cognitive impairment. Exclusion Criteria: Diagnosed or suspected neurological, psychiatric (including bipolar disorder or mania), or medical condition that might impair cognitive functioning (other than those caused by the cancer or its treatment), Visual, hearing, or physical impairment sufficient to interfere with cognitive testing or participation, Have a history of whole brain irradiation or surgery, Active diagnosis of autoimmune and/or inflammatory disorder or disorders that may influence immune processes, Chronic use of oral steroid medication, History of systematic light exposure treatment, Diagnosed sleep apnea or narcolepsy, Use of photosensitizing medications, Plan to travel across meridians during the study, Work night, early morning, or swing shifts, Adults unable to consent, individuals who are not yet adults, pregnant women and prisoners will be excluded from the study.

Ages Eligible for Study
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Minimum Age: 21 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention light<br>30 minutes of intervention systematic light exposure daily for 4 weeks. | Device: Intervention systematic light exposure<br>* Bright light using Litebook device.<br>|
| Active Comparator: Comparison light<br>30 minutes of comparison systematic light exposure daily for 4 weeks. | Device: Comparison systematic light exposure<br>* Dim light using modified Litebook device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive Functioning (Neuropsychological Tests) | Global composite z-score from baseline to 8 weeks after the intervention based on the HVLT-R; BVMT-R; Psychomotor vigilance task; Trail-making tests A and B; WAIS-IV Coding, Digit Span, Block Design; D-KEFS Color-Word Inhibition, Verbal Fluency; Conners Continuous Performance Test III. Raw scores at baseline of tests within single domains were averaged and then standardized to z-scores. The mean of the z-scores was calculated, and then this composite z-score was standardized to z-scores. Follow up intervention z-scores were calculated based on differences between raw scores at baseline and raw scores at follow-up time points and divided by the standard deviation of the baseline domain z-score) within each domain, and then averaged to create follow up global composite scores. A z-score below 0 indicated poorer performance than at baseline and a z-score above 0 indicated better performance than at baseline. | Baseline to end-of-intervention to 8 weeks after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circadian Activity Rhythms (Actigraphy) | F statistic from actigraphy was assessed as a measure of circadian activity rhythm robustness. | Baseline to end of intervention to 8 weeks later | 
| Sleep Quality (Pittsburgh Sleep Quality Index) | The Pittsburgh Sleep Quality Index consists of 19 self-rated items used to calculate sleep quality | Baseline, mid intervention, end of intervention, 8 weeks later | 
| Fatigue (FACIT-fatigue) | This is a 13-item measure of fatigue. | Baseline, mid-intervention, end of the intervention, 8 weeks later | 
| Depressed Mood (CESD) | The Center for Epidemiological Studies Depression Scale (CES-D) is a 20-item self-report instrument that measures symptoms of depressed mood over the past week. | Baseline, Mid-intervention, End of intervention, 8 weeks later | 
| Neurobehavioral Functioning (Frontal Systems Behavioral Scale) | Total raw score for entire scale (minimum = 46, maximum = 230) with a higher score indicating greater neurobehavioral symptomatology. | Baseline, mid-intervention, end-of-intervention, 8 weeks later | 
| Quality of Life (FACT-BMT) | This 50-item scale is a commonly used and well-validated measure of the functional status of cancer patients who have undergone BMT (SCT). | Baseline, End of intervention, 8 weeks post-intervention | 
| Interleukin-6 | Serum cytokine IL-6 in pg/mL | Baseline and end-of-intervention | 
| Pro-inflammatory Cytokine - TNF Alpha | Serum cytokine TNF-α in pg/mL | Baseline and end-of-intervention | 
| C-Reactive Protein | C-reactive protein in mg/L | Baseline and end-of-intervention | 
| Self-reported Cognitive Function (Patient Assessment of Own Functioning Inventory) | The 33-item Patient Assessment of Own Functioning Inventory (PAOFI) is a reliable and valid measure of perceptions of cognitive functioning (Bell et al., 2013; Chelune et al., 1986). Using a Likert scale from 1 (Almost Always) to 6 (Almost Never), ratings of 1-3 were scored 1 indicating impairment, and ratings from 4 to 6 were scored 0 indicating no impairment. Total impairment was calculated by summing the number of impaired items. | Baseline, mid-intervention, end of intervention, 8 weeks after intervention |