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Completed

NCT Number: NCT02677987

The "Light for the Brain" Study

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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Key information

Conditions

Hematopoietic Stem Cell Transplantation Behavior Behavioral Symptoms Cognition Disorders Cognitive Dysfunction Cognitive Impairments Depression Fatigue Mental Disorders Neurocognitive Disorders Pathological Conditions, Signs and Symptoms Quality of Life Signs and Symptoms Sleep

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intervention systematic light exposure

Device

Bright light using Litebook device.

Comparison systematic light exposure

Device

Dim light using modified Litebook device.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. Fatigue (FACIT-fatigue)

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

    This is a 13-item measure of fatigue.

  4. 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.

  5. 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.

  6. 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).

  7. Interleukin-6

    Time frame: Baseline and end-of-intervention

    Serum cytokine IL-6 in pg/mL

  8. Pro-inflammatory Cytokine - TNF Alpha

    Time frame: Baseline and end-of-intervention

    Serum cytokine TNF-α in pg/mL

  9. C-Reactive Protein

    Time frame: Baseline and end-of-intervention

    C-reactive protein in mg/L

  10. 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.

Other outcomes

  1. Treatment Satisfaction (FACT-TS)

    Time frame: During the 4th week of the intervention

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

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Treating Cognitive Impairments in Cancer Patients Via Systematic Light Exposure

Important dates

Study start
2016
Primary completion
2019
Study completion
2021
First posted
Feb 9, 2016
Registry last updated
Apr 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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