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The "Light for the Brain" Study

Primary Purpose

Hematopoietic Stem Cell Transplantation, Cognitive Impairments, Sleep

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention systematic light exposure
Comparison systematic light exposure
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hematopoietic Stem Cell Transplantation

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Northwestern University Feinberg School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention light

Comparison light

Arm Description

30 minutes of intervention systematic light exposure daily for 4 weeks.

30 minutes of comparison systematic light exposure daily for 4 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Circadian Activity Rhythms (Actigraphy)
F statistic from actigraphy was assessed as a measure of circadian activity rhythm robustness.
Sleep Quality (Pittsburgh Sleep Quality Index)
The Pittsburgh Sleep Quality Index consists of 19 self-rated items used to calculate sleep quality
Fatigue (FACIT-fatigue)
This is a 13-item measure of fatigue.
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.
Neurobehavioral Functioning (Frontal Systems Behavioral Scale)
Total raw score for entire scale (minimum = 46, maximum = 230) with a higher score indicating greater neurobehavioral symptomatology.
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).
Interleukin-6
Serum cytokine IL-6 in pg/mL
Pro-inflammatory Cytokine - TNF Alpha
Serum cytokine TNF-α in pg/mL
C-Reactive Protein
C-reactive protein in mg/L
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.

Full Information

First Posted
January 22, 2016
Last Updated
March 22, 2022
Sponsor
Northwestern University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02677987
Brief Title
The "Light for the Brain" Study
Official Title
Treating Cognitive Impairments in Cancer Patients Via Systematic Light Exposure
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
October 2019 (Actual)
Study Completion Date
March 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematopoietic Stem Cell Transplantation, Cognitive Impairments, Sleep, Depression, Fatigue, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention light
Arm Type
Experimental
Arm Description
30 minutes of intervention systematic light exposure daily for 4 weeks.
Arm Title
Comparison light
Arm Type
Active Comparator
Arm Description
30 minutes of comparison systematic light exposure daily for 4 weeks.
Intervention Type
Device
Intervention Name(s)
Intervention systematic light exposure
Intervention Description
Bright light using Litebook device.
Intervention Type
Device
Intervention Name(s)
Comparison systematic light exposure
Intervention Description
Dim light using modified Litebook device.
Primary Outcome Measure Information:
Title
Cognitive Functioning (Neuropsychological Tests)
Description
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 Outcome Measure Information:
Title
Circadian Activity Rhythms (Actigraphy)
Description
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
Title
Sleep Quality (Pittsburgh Sleep Quality Index)
Description
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
Title
Fatigue (FACIT-fatigue)
Description
This is a 13-item measure of fatigue.
Time Frame
Baseline, mid-intervention, end of the intervention, 8 weeks later
Title
Depressed Mood (CESD)
Description
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
Title
Neurobehavioral Functioning (Frontal Systems Behavioral Scale)
Description
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
Title
Quality of Life (FACT-BMT)
Description
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
Title
Interleukin-6
Description
Serum cytokine IL-6 in pg/mL
Time Frame
Baseline and end-of-intervention
Title
Pro-inflammatory Cytokine - TNF Alpha
Description
Serum cytokine TNF-α in pg/mL
Time Frame
Baseline and end-of-intervention
Title
C-Reactive Protein
Description
C-reactive protein in mg/L
Time Frame
Baseline and end-of-intervention
Title
Self-reported Cognitive Function (Patient Assessment of Own Functioning Inventory)
Description
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
Other Pre-specified Outcome Measures:
Title
Treatment Satisfaction (FACT-TS)
Description
Range between 0 and 5, with 5 meaning higher treatment satisfaction
Time Frame
During the 4th week of the intervention
Title
Credibility/Expectancy (Credibility/Expectancy Questionnaire)
Description
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
Title
Usage of Light Box (Integrated Meter Measurement and Litebook Log)
Description
Length of time light box has been used.
Time Frame
Throughout intervention period (4 weeks)
Title
Chronotype (Morningness-eveningness Questionnaire)
Description
Measure determines chronotype with a lower score indicating an evening type and a higher score indicating a morning type.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have a history of HSCT, 1 to 5 years post-HSCT, Relapse-free since most recent HSCT, Age 21 or older, English language proficient Able to provide informed consent Endorse subjective cognitive impairment. Exclusion Criteria: 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), Visual, hearing, or physical impairment sufficient to interfere with cognitive testing or participation, Have a history of whole brain irradiation or surgery, Active diagnosis of autoimmune and/or inflammatory disorder or disorders that may influence immune processes, Chronic use of oral steroid medication, History of systematic light exposure treatment, Diagnosed sleep apnea or narcolepsy, Use of photosensitizing medications, Plan to travel across meridians during the study, Work night, early morning, or swing shifts, Adults unable to consent, individuals who are not yet adults, pregnant women and prisoners will be excluded from the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa M Wu, PhD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35904252
Citation
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. Erratum In: J Biol Rhythms. 2022 Sep 1;:7487304221120697.
Results Reference
derived

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The "Light for the Brain" Study

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