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| ID | Type | Description | Link |
|---|---|---|---|
| 7K07CA184145-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention light | Experimental | 30 minutes of intervention systematic light exposure daily for 4 weeks. |
|
| Comparison light | Active Comparator | 30 minutes of comparison systematic light exposure daily for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention systematic light exposure | Device | Bright light using Litebook device. |
| |
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Satisfaction (FACT-TS) | Range between 0 and 5, with 5 meaning higher treatment satisfaction | During the 4th week of the intervention |
| Credibility/Expectancy (Credibility/Expectancy Questionnaire) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa M Wu, PhD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35904252 | Derived | Wu LM, Valdimarsdottir HB, Amidi A, Reid KJ, Ancoli-Israel S, Bovbjerg K, Fox RS, Walker L, Matharu A, Kaseda ET, Galvin JP, Adekola K, Winkel G, Penedo F, Redd WH. Examining the Efficacy of Bright Light Therapy on Cognitive Function in Hematopoietic Stem Cell Transplant Survivors. J Biol Rhythms. 2022 Oct;37(5):471-483. doi: 10.1177/07487304221107833. Epub 2022 Jul 29. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Light | 30 minutes of intervention systematic light exposure daily for 4 weeks. Intervention systematic light exposure: Bright light using Litebook device. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Light | 30 minutes of intervention systematic light exposure daily for 4 weeks. Intervention systematic light exposure: Bright light using Litebook device. |
| BG001 | Comparison Light |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Error | z-score | Baseline to end-of-intervention to 8 weeks after the intervention |
|
13 to 16 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Light | 30 minutes of intervention systematic light exposure daily for 4 weeks. Intervention systematic light exposure: Bright light using Litebook device. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa M. Wu, Ph.D. | Northwestern University Feinberg School of Medicine | (312) 503-7722 | lisa.wu1@northwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jul 16, 2020 | Feb 7, 2022 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D003863 | Depression |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| Comparison systematic light exposure |
| Device |
Dim light using modified Litebook device. |
|
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 |
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.
| Baseline |
| Usage of Light Box (Integrated Meter Measurement and Litebook Log) | Length of time light box has been used. | Throughout intervention period (4 weeks) |
| Chronotype (Morningness-eveningness Questionnaire) | Measure determines chronotype with a lower score indicating an evening type and a higher score indicating a morning type. | Baseline |
30 minutes of comparison long wavelength systematic light exposure daily for 4 weeks.
Comparison systematic light exposure: Dim light using modified Litebook device.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Wechsler Test of Adult Reading | Baseline estimate of premorbid intellectual functioning; The WTAR (Wechsler, 2001) comprises 50 words with irregular pronunciations that participants read aloud. The raw score ranges from 0 to 50, with a higher score indicating better performance, and the raw score can be transformed to an age-adjusted standard score, which is used to predict IQ (M = 100; SD = 15). | Mean | Standard Deviation | units on a scale |
|
| Intervention Light |
30 minutes of intervention systematic light exposure daily for 4 weeks. Intervention systematic light exposure: Bright light using Litebook device. |
| OG001 | 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. |
|
|
| Secondary | Circadian Activity Rhythms (Actigraphy) | F statistic from actigraphy was assessed as a measure of circadian activity rhythm robustness. | Posted | Mean | Standard Error | units on a scale | Baseline to end of intervention to 8 weeks later |
|
|
|
| Secondary | Sleep Quality (Pittsburgh Sleep Quality Index) | The Pittsburgh Sleep Quality Index consists of 19 self-rated items used to calculate sleep quality | Posted | Mean | Standard Error | units on a scale | Baseline, mid intervention, end of intervention, 8 weeks later |
|
|
|
| Secondary | Fatigue (FACIT-fatigue) | This is a 13-item measure of fatigue. | Posted | Mean | Standard Error | units on a scale | Baseline, mid-intervention, end of the intervention, 8 weeks later |
|
|
|
| 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. | Posted | Mean | Standard Error | units on a scale | Baseline, Mid-intervention, End of intervention, 8 weeks later |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, mid-intervention, end-of-intervention, 8 weeks later |
|
|
|
| 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). | Posted | Mean | Standard Error | units on a scale | Baseline, End of intervention, 8 weeks post-intervention |
|
|
|
| Secondary | Interleukin-6 | Serum cytokine IL-6 in pg/mL | Posted | Mean | Standard Deviation | units on a scale | Baseline and end-of-intervention |
|
|
|
| Secondary | Pro-inflammatory Cytokine - TNF Alpha | Serum cytokine TNF-α in pg/mL | Two participants did not provide blood samples at the end-of-intervention | Posted | Mean | Standard Deviation | units on a scale | Baseline and end-of-intervention |
|
|
|
| Secondary | C-Reactive Protein | C-reactive protein in mg/L | Posted | Mean | Standard Deviation | units on a scale | Baseline and end-of-intervention |
|
|
|
| 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. | Posted | Mean | Standard Error | units on a scale | Baseline, mid-intervention, end of intervention, 8 weeks after intervention |
|
|
|
| Other Pre-specified | Treatment Satisfaction (FACT-TS) | Range between 0 and 5, with 5 meaning higher treatment satisfaction | Posted | Mean | Standard Deviation | units on a scale | During the 4th week of the intervention |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Other Pre-specified | Usage of Light Box (Integrated Meter Measurement and Litebook Log) | Length of time light box has been used. | Posted | Mean | Standard Deviation | days | Throughout intervention period (4 weeks) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | 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. | 0 | 24 | 0 | 24 | 0 | 24 |
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| D001519 |
| Behavior |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 8 weeks after intervention |
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| End of treatment |
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| 8 weeks later |
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| End of intervention |
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| 8 weeks post-intervention |
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| End of intervention |
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| 8 weeks post intervention |
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| Mid-intervention |
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| End-of-intervention |
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| 8 weeks later |
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| 8 weeks post-intervention |
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| End-of-intervention |
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| End of intervention |
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| 8 weeks after intervention |
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