The "Light for the Brain" Study

Northwestern University47 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hematopoietic Stem Cell Transplantation Cognitive Impairments Sleep Depression

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Have a history of HSCT, 2. 1 to 5 years post-HSCT, 3. Relapse-free since most recent HSCT, 4. Age 21 or older, 5. English language proficient 6. Able to provide informed consent 7. Endorse subjective cognitive impairment. Exclusion Criteria: 1. 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), 2. Visual, hearing, or physical impairment sufficient to interfere with cognitive testing or participation, 3. Have a history of whole brain irradiation or surgery, 4. Active diagnosis of autoimmune and/or inflammatory disorder or disorders that may influence immune processes, 5. Chronic use of oral steroid medication, 6. History of systematic light exposure treatment, 7. Diagnosed sleep apnea or narcolepsy, 8. Use of photosensitizing medications, 9. Plan to travel across meridians during the study, 10. Work night, early morning, or swing shifts, 11. Adults unable to consent, individuals who are not yet adults, pregnant women and prisoners will be excluded from the study.

Outcomes

Primary Outcomes

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.

Time frame: Baseline to end-of-intervention to 8 weeks after the intervention

Secondary Outcomes

Circadian Activity Rhythms (Actigraphy)

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

Time frame: 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

Time frame: Baseline, mid intervention, end of intervention, 8 weeks later

Fatigue (FACIT-fatigue)

This is a 13-item measure of fatigue.

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: Baseline, End of intervention, 8 weeks post-intervention

Interleukin-6

Serum cytokine IL-6 in pg/mL

Time frame: Baseline and end-of-intervention

Pro-inflammatory Cytokine - TNF Alpha

Serum cytokine TNF-α in pg/mL

Time frame: Baseline and end-of-intervention

C-Reactive Protein

C-reactive protein in mg/L

Time frame: 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.

Time frame: Baseline, mid-intervention, end of intervention, 8 weeks after intervention

The "Light for the Brain" Study

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes