Trial Outcomes & Findings for The "Light for the Brain" Study (NCT NCT02677987)

The "Light for the Brain" Study

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.

F statistic from actigraphy was assessed as a measure of circadian activity rhythm robustness.

The Pittsburgh Sleep Quality Index consists of 19 self-rated items used to calculate sleep quality

This is a 13-item measure of fatigue.

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.

Total raw score for entire scale (minimum = 46, maximum = 230) with a higher score indicating greater neurobehavioral symptomatology.

This 50-item scale is a commonly used and well-validated measure of the functional status of cancer patients who have undergone BMT (SCT).

Serum cytokine IL-6 in pg/mL

Serum cytokine TNF-α in pg/mL

C-reactive protein in mg/L

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.

Range between 0 and 5, with 5 meaning higher treatment satisfaction

Treatment credibility and outcome expectancy were assessed at baseline with the mean of the first 3 items of the Credibility/Expectancy Questionnaire. Items are scored on a Likert scale from 1 to 9, and the term "symptoms" was replaced with "thinking, memory and concentration problems." Higher scores represent greater credibility and outcome expectancy.

Length of time light box has been used.

Measure determines chronotype with a lower score indicating an evening type and a higher score indicating a morning type.