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The Light for the Brain Study

Treating Cognitive Impairments in Cancer Patients Via Systematic Light Exposure

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02677987
Enrollment
47
Registered
2016-02-09
Start date
2016-04-30
Completion date
2021-03-31
Last updated
2022-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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.

Interventions

Bright light using Litebook device.

Dim light using modified Litebook device.

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Northwestern University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Cognitive Functioning (Neuropsychological Tests)Baseline to end-of-intervention to 8 weeks after the interventionGlobal 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.

Secondary

MeasureTime frameDescription
Depressed Mood (CESD)Baseline, Mid-intervention, End of intervention, 8 weeks laterThe 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.
Interleukin-6Baseline and end-of-interventionSerum cytokine IL-6 in pg/mL
Pro-inflammatory Cytokine - TNF AlphaBaseline and end-of-interventionSerum cytokine TNF-α in pg/mL
C-Reactive ProteinBaseline and end-of-interventionC-reactive protein in mg/L
Self-reported Cognitive Function (Patient Assessment of Own Functioning Inventory)Baseline, mid-intervention, end of intervention, 8 weeks after interventionThe 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.
Circadian Activity Rhythms (Actigraphy)Baseline to end of intervention to 8 weeks laterF statistic from actigraphy was assessed as a measure of circadian activity rhythm robustness.
Sleep Quality (Pittsburgh Sleep Quality Index)Baseline, mid intervention, end of intervention, 8 weeks laterThe Pittsburgh Sleep Quality Index consists of 19 self-rated items used to calculate sleep quality
Fatigue (FACIT-fatigue)Baseline, mid-intervention, end of the intervention, 8 weeks laterThis is a 13-item measure of fatigue.
Neurobehavioral Functioning (Frontal Systems Behavioral Scale)Baseline, mid-intervention, end-of-intervention, 8 weeks laterTotal raw score for entire scale (minimum = 46, maximum = 230) with a higher score indicating greater neurobehavioral symptomatology.
Quality of Life (FACT-BMT)Baseline, End of intervention, 8 weeks post-interventionThis 50-item scale is a commonly used and well-validated measure of the functional status of cancer patients who have undergone BMT (SCT).

Other

MeasureTime frameDescription
Usage of Light Box (Integrated Meter Measurement and Litebook Log)Throughout intervention period (4 weeks)Length of time light box has been used.
Chronotype (Morningness-eveningness Questionnaire)BaselineMeasure determines chronotype with a lower score indicating an evening type and a higher score indicating a morning type.
Credibility/Expectancy (Credibility/Expectancy Questionnaire)BaselineTreatment 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.
Treatment Satisfaction (FACT-TS)During the 4th week of the interventionRange between 0 and 5, with 5 meaning higher treatment satisfaction

Countries

United States

Participant flow

Participants by arm

ArmCount
Intervention Light
30 minutes of intervention systematic light exposure daily for 4 weeks. Intervention systematic light exposure: Bright light using Litebook device.
23
Comparison Light
30 minutes of comparison long wavelength systematic light exposure daily for 4 weeks. Comparison systematic light exposure: Dim light using modified Litebook device.
24
Total47

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up10
Overall StudyWithdrawal by Subject30

Baseline characteristics

CharacteristicIntervention LightTotalComparison Light
Age, Continuous58.0 years
STANDARD_DEVIATION 11.2
56.8 years
STANDARD_DEVIATION 12.1
55.5 years
STANDARD_DEVIATION 13
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants3 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
21 Participants44 Participants23 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants3 Participants2 Participants
Race (NIH/OMB)
Black or African American
1 Participants3 Participants2 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants3 Participants1 Participants
Race (NIH/OMB)
White
19 Participants38 Participants19 Participants
Region of Enrollment
United States
23 participants47 participants24 participants
Sex: Female, Male
Female
17 Participants30 Participants13 Participants
Sex: Female, Male
Male
6 Participants17 Participants11 Participants
Wechsler Test of Adult Reading105.6 units on a scale
STANDARD_DEVIATION 9.5
108.0 units on a scale
STANDARD_DEVIATION 8.3
110.3 units on a scale
STANDARD_DEVIATION 11.1

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 230 / 24
other
Total, other adverse events
0 / 230 / 24
serious
Total, serious adverse events
0 / 230 / 24

Outcome results

Primary

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

ArmMeasureGroupValue (MEAN)Dispersion
Intervention LightCognitive Functioning (Neuropsychological Tests)End of intervention0.24 z-scoreStandard Error 0.14
Intervention LightCognitive Functioning (Neuropsychological Tests)8 weeks after intervention0.43 z-scoreStandard Error 0.14
Comparison LightCognitive Functioning (Neuropsychological Tests)End of intervention0.16 z-scoreStandard Error 0.14
Comparison LightCognitive Functioning (Neuropsychological Tests)8 weeks after intervention0.50 z-scoreStandard Error 0.14
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
Intervention LightCircadian Activity Rhythms (Actigraphy)Baseline1696.19 units on a scaleStandard Error 290.49
Intervention LightCircadian Activity Rhythms (Actigraphy)End of intervention1999.72 units on a scaleStandard Error 295.87
Intervention LightCircadian Activity Rhythms (Actigraphy)8 weeks after intervention1858.04 units on a scaleStandard Error 293.04
Comparison LightCircadian Activity Rhythms (Actigraphy)Baseline1551.72 units on a scaleStandard Error 293.04
Comparison LightCircadian Activity Rhythms (Actigraphy)End of intervention1373.88 units on a scaleStandard Error 293.04
Comparison LightCircadian Activity Rhythms (Actigraphy)8 weeks after intervention1466.82 units on a scaleStandard Error 295.87
Secondary

C-Reactive Protein

C-reactive protein in mg/L

Time frame: Baseline and end-of-intervention

ArmMeasureGroupValue (MEAN)Dispersion
Intervention LightC-Reactive ProteinBaseline5.67 units on a scaleStandard Deviation 10.11
Intervention LightC-Reactive ProteinEnd-of-intervention5.95 units on a scaleStandard Deviation 15.29
Comparison LightC-Reactive ProteinBaseline3.68 units on a scaleStandard Deviation 3.09
Comparison LightC-Reactive ProteinEnd-of-intervention3.53 units on a scaleStandard Deviation 2.61
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
Intervention LightDepressed Mood (CESD)Mid-intervention20.4583 units on a scaleStandard Error 1.5343
Intervention LightDepressed Mood (CESD)Baseline18.6293 units on a scaleStandard Error 1.3655
Intervention LightDepressed Mood (CESD)8 weeks post intervention20.1206 units on a scaleStandard Error 1.6286
Intervention LightDepressed Mood (CESD)End of intervention19.1489 units on a scaleStandard Error 1.2097
Comparison LightDepressed Mood (CESD)8 weeks post intervention19.0299 units on a scaleStandard Error 1.1423
Comparison LightDepressed Mood (CESD)Baseline20.4500 units on a scaleStandard Error 1.4378
Comparison LightDepressed Mood (CESD)End of intervention17.0500 units on a scaleStandard Error 1.1821
Comparison LightDepressed Mood (CESD)Mid-intervention18.1000 units on a scaleStandard Error 1.0366
Secondary

Fatigue (FACIT-fatigue)

This is a 13-item measure of fatigue.

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

ArmMeasureGroupValue (MEAN)Dispersion
Intervention LightFatigue (FACIT-fatigue)Baseline29.9804 units on a scaleStandard Error 1.7374
Intervention LightFatigue (FACIT-fatigue)Mid-intervention29.5833 units on a scaleStandard Error 2.1666
Intervention LightFatigue (FACIT-fatigue)End of intervention30.8219 units on a scaleStandard Error 1.9725
Intervention LightFatigue (FACIT-fatigue)8 weeks post-intervention30.5041 units on a scaleStandard Error 2.1484
Comparison LightFatigue (FACIT-fatigue)8 weeks post-intervention32.3366 units on a scaleStandard Error 1.8079
Comparison LightFatigue (FACIT-fatigue)Baseline30.0000 units on a scaleStandard Error 1.5458
Comparison LightFatigue (FACIT-fatigue)End of intervention33.7513 units on a scaleStandard Error 1.4237
Comparison LightFatigue (FACIT-fatigue)Mid-intervention33.6356 units on a scaleStandard Error 1.3701
Secondary

Interleukin-6

Serum cytokine IL-6 in pg/mL

Time frame: Baseline and end-of-intervention

ArmMeasureGroupValue (MEAN)Dispersion
Intervention LightInterleukin-6Baseline3.24 units on a scaleStandard Deviation 2.72
Intervention LightInterleukin-6End-of-intervention3.98 units on a scaleStandard Deviation 4.87
Comparison LightInterleukin-6Baseline3.24 units on a scaleStandard Deviation 1.79
Comparison LightInterleukin-6End-of-intervention3.28 units on a scaleStandard Deviation 2.6
Secondary

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

Population: Participants did not always complete this measure, which accounts for why there are sometimes fewer participants than the overall number of participants analyzed at different time points. Linear mixed models allows for missing time points.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention LightNeurobehavioral Functioning (Frontal Systems Behavioral Scale)Baseline91.39 score on a scaleStandard Deviation 17.71
Intervention LightNeurobehavioral Functioning (Frontal Systems Behavioral Scale)Mid-intervention92.96 score on a scaleStandard Deviation 21.12
Intervention LightNeurobehavioral Functioning (Frontal Systems Behavioral Scale)End-of-intervention89.04 score on a scaleStandard Deviation 19.69
Intervention LightNeurobehavioral Functioning (Frontal Systems Behavioral Scale)8 weeks later87.29 score on a scaleStandard Deviation 21.58
Comparison LightNeurobehavioral Functioning (Frontal Systems Behavioral Scale)8 weeks later92.78 score on a scaleStandard Deviation 19.47
Comparison LightNeurobehavioral Functioning (Frontal Systems Behavioral Scale)Baseline89.36 score on a scaleStandard Deviation 19.57
Comparison LightNeurobehavioral Functioning (Frontal Systems Behavioral Scale)End-of-intervention88.90 score on a scaleStandard Deviation 19.08
Comparison LightNeurobehavioral Functioning (Frontal Systems Behavioral Scale)Mid-intervention90.55 score on a scaleStandard Deviation 18.56
Secondary

Pro-inflammatory Cytokine - TNF Alpha

Serum cytokine TNF-α in pg/mL

Time frame: Baseline and end-of-intervention

Population: Two participants did not provide blood samples at the end-of-intervention

ArmMeasureGroupValue (MEAN)Dispersion
Intervention LightPro-inflammatory Cytokine - TNF AlphaBaseline7.55 units on a scaleStandard Deviation 2.49
Intervention LightPro-inflammatory Cytokine - TNF AlphaEnd-of-intervention7.44 units on a scaleStandard Deviation 3.26
Comparison LightPro-inflammatory Cytokine - TNF AlphaBaseline7.00 units on a scaleStandard Deviation 2.13
Comparison LightPro-inflammatory Cytokine - TNF AlphaEnd-of-intervention7.30 units on a scaleStandard Deviation 2.36
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
Intervention LightQuality of Life (FACT-BMT)Baseline110.27 units on a scaleStandard Error 4.187
Intervention LightQuality of Life (FACT-BMT)End of intervention116.88 units on a scaleStandard Error 3.5606
Intervention LightQuality of Life (FACT-BMT)8 weeks post-intervention112.68 units on a scaleStandard Error 4.4154
Comparison LightQuality of Life (FACT-BMT)Baseline109.66 units on a scaleStandard Error 4.2157
Comparison LightQuality of Life (FACT-BMT)End of intervention111.94 units on a scaleStandard Error 4.9821
Comparison LightQuality of Life (FACT-BMT)8 weeks post-intervention110.92 units on a scaleStandard Error 5.097
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
Intervention LightSelf-reported Cognitive Function (Patient Assessment of Own Functioning Inventory)Mid-intervention6.5927 units on a scaleStandard Error 1.2457
Intervention LightSelf-reported Cognitive Function (Patient Assessment of Own Functioning Inventory)Baseline8.5217 units on a scaleStandard Error 1.219
Intervention LightSelf-reported Cognitive Function (Patient Assessment of Own Functioning Inventory)End of intervention4.7065 units on a scaleStandard Error 1.258
Intervention LightSelf-reported Cognitive Function (Patient Assessment of Own Functioning Inventory)8 weeks after intervention7.0445 units on a scaleStandard Error 1.284
Comparison LightSelf-reported Cognitive Function (Patient Assessment of Own Functioning Inventory)8 weeks after intervention6.2142 units on a scaleStandard Error 1.2023
Comparison LightSelf-reported Cognitive Function (Patient Assessment of Own Functioning Inventory)Baseline7.9703 units on a scaleStandard Error 1.2023
Comparison LightSelf-reported Cognitive Function (Patient Assessment of Own Functioning Inventory)Mid-intervention6.9583 units on a scaleStandard Error 1.1934
Comparison LightSelf-reported Cognitive Function (Patient Assessment of Own Functioning Inventory)End of intervention5.5905 units on a scaleStandard Error 1.2023
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
Intervention LightSleep Quality (Pittsburgh Sleep Quality Index)Baseline7.3157 units on a scaleStandard Error 0.7672
Intervention LightSleep Quality (Pittsburgh Sleep Quality Index)Mid-treatment6.7500 units on a scaleStandard Error 0.8544
Intervention LightSleep Quality (Pittsburgh Sleep Quality Index)End of treatment6.5296 units on a scaleStandard Error 0.7567
Intervention LightSleep Quality (Pittsburgh Sleep Quality Index)8 weeks later6.1922 units on a scaleStandard Error 0.7345
Comparison LightSleep Quality (Pittsburgh Sleep Quality Index)8 weeks later8.3745 units on a scaleStandard Error 0.8023
Comparison LightSleep Quality (Pittsburgh Sleep Quality Index)Baseline8.5000 units on a scaleStandard Error 0.691
Comparison LightSleep Quality (Pittsburgh Sleep Quality Index)End of treatment7.5500 units on a scaleStandard Error 0.6343
Comparison LightSleep Quality (Pittsburgh Sleep Quality Index)Mid-treatment7.7500 units on a scaleStandard Error 0.7137
Other Pre-specified

Chronotype (Morningness-eveningness Questionnaire)

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

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Intervention LightChronotype (Morningness-eveningness Questionnaire)17.91 score on a scaleStandard Deviation 3.15
Comparison LightChronotype (Morningness-eveningness Questionnaire)15.65 score on a scaleStandard Deviation 4.11
Other Pre-specified

Credibility/Expectancy (Credibility/Expectancy Questionnaire)

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.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Intervention LightCredibility/Expectancy (Credibility/Expectancy Questionnaire)6.9 units on a scaleStandard Deviation 1.5
Comparison LightCredibility/Expectancy (Credibility/Expectancy Questionnaire)6.3 units on a scaleStandard Deviation 1.4
Other Pre-specified

Treatment Satisfaction (FACT-TS)

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

Time frame: During the 4th week of the intervention

ArmMeasureValue (MEAN)Dispersion
Intervention LightTreatment Satisfaction (FACT-TS)2.5 units on a scaleStandard Deviation 0.8
Comparison LightTreatment Satisfaction (FACT-TS)2.0 units on a scaleStandard Deviation 1
Other Pre-specified

Usage of Light Box (Integrated Meter Measurement and Litebook Log)

Length of time light box has been used.

Time frame: Throughout intervention period (4 weeks)

ArmMeasureValue (MEAN)Dispersion
Intervention LightUsage of Light Box (Integrated Meter Measurement and Litebook Log)21.1 daysStandard Deviation 7.5
Comparison LightUsage of Light Box (Integrated Meter Measurement and Litebook Log)21.0 daysStandard Deviation 8.7

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026