The "Light for the Brain" Study

March 22, 2022 updated by: Lisa M. Wu, Northwestern University

Treating Cognitive Impairments in Cancer Patients Via Systematic Light Exposure

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Feinberg School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention light
30 minutes of intervention systematic light exposure daily for 4 weeks.
Device: Intervention systematic light exposure
Bright light using Litebook device.
Active Comparator: Comparison light
30 minutes of comparison systematic light exposure daily for 4 weeks.
Device: Comparison systematic light exposure
Dim light using modified Litebook device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive Functioning (Neuropsychological Tests)
Time Frame: Baseline to end-of-intervention to 8 weeks after the intervention

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Circadian Activity Rhythms (Actigraphy)
Time Frame: Baseline to end of intervention to 8 weeks later
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)
Time Frame: Baseline, mid intervention, end of intervention, 8 weeks later
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)
Time Frame: Baseline, mid-intervention, end of the intervention, 8 weeks later
This is a 13-item measure of fatigue.
Baseline, mid-intervention, end of the intervention, 8 weeks later
Depressed Mood (CESD)
Time Frame: Baseline, Mid-intervention, End of intervention, 8 weeks later
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)
Time Frame: Baseline, mid-intervention, end-of-intervention, 8 weeks later
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)
Time Frame: Baseline, End of intervention, 8 weeks post-intervention
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
Time Frame: Baseline and end-of-intervention
Serum cytokine IL-6 in pg/mL
Baseline and end-of-intervention
Pro-inflammatory Cytokine - TNF Alpha
Time Frame: Baseline and end-of-intervention
Serum cytokine TNF-α in pg/mL
Baseline and end-of-intervention
C-Reactive Protein
Time Frame: Baseline and end-of-intervention
C-reactive protein in mg/L
Baseline and end-of-intervention
Self-reported Cognitive Function (Patient Assessment of Own Functioning Inventory)
Time Frame: Baseline, mid-intervention, end of intervention, 8 weeks after intervention
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Satisfaction (FACT-TS)
Time Frame: During the 4th week of the intervention
Range between 0 and 5, with 5 meaning higher treatment satisfaction
During the 4th week of the intervention
Credibility/Expectancy (Credibility/Expectancy Questionnaire)
Time Frame: Baseline
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)
Time Frame: Throughout intervention period (4 weeks)
Length of time light box has been used.
Throughout intervention period (4 weeks)
Chronotype (Morningness-eveningness Questionnaire)
Time Frame: Baseline
Measure determines chronotype with a lower score indicating an evening type and a higher score indicating a morning type.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Lisa M Wu, PhD, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

March 1, 2021

Study Registration Dates

First Submitted

January 22, 2016

First Submitted That Met QC Criteria

February 8, 2016

First Posted (Estimate)

February 9, 2016

Study Record Updates

Last Update Posted (Actual)

April 18, 2022

Last Update Submitted That Met QC Criteria

March 22, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00201700
  • 7K07CA184145-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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