The "Light for the Brain" Study

Depression Clinical Trial

Official title:

Treating Cognitive Impairments in Cancer Patients Via Systematic Light Exposure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02677987
• Other study ID #: STU00201700
• Secondary ID: 7K07CA184145-02
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: March 2021

Study information

• Verified date: March 2022
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: March 2021
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• Intervention systematic light exposure
Bright light using Litebook device.
• Comparison systematic light exposure
Dim light using modified Litebook device.

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment Satisfaction (FACT-TS)	Range between 0 and 5, with 5 meaning higher treatment satisfaction	During the 4th week of the intervention
Other	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.	Baseline
Other	Usage of Light Box (Integrated Meter Measurement and Litebook Log)	Length of time light box has been used.	Throughout intervention period (4 weeks)
Other	Chronotype (Morningness-eveningness Questionnaire)	Measure determines chronotype with a lower score indicating an evening type and a higher score indicating a morning type.	Baseline
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.	Baseline to end-of-intervention to 8 weeks after the intervention
Secondary	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
Secondary	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
Secondary	Fatigue (FACIT-fatigue)	This is a 13-item measure of fatigue.	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.	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.	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).	Baseline, End of intervention, 8 weeks post-intervention
Secondary	Interleukin-6	Serum cytokine IL-6 in pg/mL	Baseline and end-of-intervention
Secondary	Pro-inflammatory Cytokine - TNF Alpha	Serum cytokine TNF-a in pg/mL	Baseline and end-of-intervention
Secondary	C-Reactive Protein	C-reactive protein in mg/L	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.	Baseline, mid-intervention, end of intervention, 8 weeks after intervention