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Trial record 7 of 67 for:    Behaviors and Mental Disorders[CONDITION-BROWSE-BRANCH] | Recruiting, Not yet recruiting, Available Studies | ( Map: Illinois, United States ) | NIH, U.S. Fed

The "Light for the Brain" Study

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ClinicalTrials.gov Identifier: NCT02677987
Recruitment Status : Recruiting
First Posted : February 9, 2016
Last Update Posted : July 3, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Lisa M. Wu, Northwestern University

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.

Condition or disease Intervention/treatment Phase
Hematopoietic Stem Cell Transplantation Cognitive Impairments Sleep Depression Fatigue Quality of Life Device: Intervention systematic light exposure Device: Comparison systematic light exposure Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Treating Cognitive Impairments in Cancer Patients Via Systematic Light Exposure
Study Start Date : April 2016
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2021

Arm Intervention/treatment
Experimental: Intervention light
30 minutes of intervention systematic light exposure daily for 4 weeks.
Device: Intervention systematic light exposure
Active Comparator: Comparison light
30 minutes of comparison systematic light exposure daily for 4 weeks.
Device: Comparison systematic light exposure



Primary Outcome Measures :
  1. Cognitive functioning (neuropsychological tests and self-report) [ Time Frame: Baseline ]
  2. Cognitive functioning (neuropsychological tests and self-report) [ Time Frame: Change from Baseline to the 4th week of the intervention ]
  3. Cognitive functioning (neuropsychological tests and self-report) [ Time Frame: Change from Baseline to 2 months after the intervention ]

Secondary Outcome Measures :
  1. Circadian activity rhythms (actigraphy) [ Time Frame: Baseline ]
  2. Circadian activity rhythms (actigraphy) [ Time Frame: During the 4th week of the intervention ]
  3. Circadian activity rhythms (actigraphy) [ Time Frame: 2 months after the intervention ]
  4. Sleep quality (Pittsburgh Sleep Quality Index) [ Time Frame: Baseline ]
  5. Sleep quality (Pittsburgh Sleep Quality Index) [ Time Frame: During the 4th week of the intervention ]
  6. Sleep quality (Pittsburgh Sleep Quality Index) [ Time Frame: 2 months after the intervention ]
  7. Fatigue (FACIT-fatigue) [ Time Frame: Baseline ]
  8. Fatigue (FACIT-fatigue) [ Time Frame: During the 4th week of the intervention ]
  9. Fatigue (FACIT-fatigue) [ Time Frame: 2 months after the intervention ]
  10. Depressed mood (CESD) [ Time Frame: Baseline ]
  11. Depressed mood (CESD) [ Time Frame: During the 4th week of the intervention ]
  12. Depressed mood (CESD) [ Time Frame: 2 months after the intervention ]
  13. Neurobehavioral functioning (frontal systems behavioral scale) [ Time Frame: Baseline ]
  14. Neurobehavioral functioning (frontal systems behavioral scale) [ Time Frame: During the 4th week of the intervention ]
  15. Neurobehavioral functioning (frontal systems behavioral scale) [ Time Frame: 2 months after the intervention ]
  16. Quality of life (FACT-BMT) [ Time Frame: Baseline ]
  17. Quality of life (FACT-BMT) [ Time Frame: During the 4th week of the intervention ]
  18. Quality of life (FACT-BMT) [ Time Frame: 2 months after the intervention ]
  19. Pro-inflammatory cytokines [ Time Frame: Baseline ]
  20. Pro-inflammatory cytokines [ Time Frame: During the 4th week of the intervention ]
  21. C-Reactive Protein [ Time Frame: Baseline ]
  22. C-Reactive Protein [ Time Frame: During the 4th week of the intervention ]
  23. Peripheral blood mononuclear cells [ Time Frame: Baseline ]
  24. Peripheral blood mononuclear cells [ Time Frame: During the 4th week of the intervention ]
  25. Intracellular ribonucleic acid [ Time Frame: Baseline ]
  26. Intracellular ribonucleic acid [ Time Frame: During the 4th week of the intervention ]

Other Outcome Measures:
  1. Treatment satisfaction (FACT-TS) [ Time Frame: During the 4th week of the intervention ]
  2. Credibility/Expectancy (Credibility/Expectancy questionnaire) [ Time Frame: Baseline ]
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02677987


Contacts
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Contact: Lisa M Wu, PhD (312)503-7722 lisa.wu1@northwestern.edu

Locations
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United States, Illinois
Northwestern University Feinberg School of Medicine Recruiting
Chicago, Illinois, United States, 60611
Contact: Lisa M Wu, PhD    312-503-7722    lisa.wu1@northwestern.edu   
Contact       lightstudy@northwestern.edu   
Sponsors and Collaborators
Northwestern University
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Lisa M Wu, PhD Northwestern University

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Responsible Party: Lisa M. Wu, Assistant Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT02677987     History of Changes
Other Study ID Numbers: STU00201700
7K07CA184145-02 ( U.S. NIH Grant/Contract )
First Posted: February 9, 2016    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Fatigue
Cognitive Dysfunction
Signs and Symptoms
Cognition Disorders
Neurocognitive Disorders
Mental Disorders