<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03304587</url>
  </required_header>
  <id_info>
    <org_study_id>201703147</org_study_id>
    <secondary_id>1R15NR016828-01A1</secondary_id>
    <nct_id>NCT03304587</nct_id>
  </id_info>
  <brief_title>Effects of Bright Light on Co-occurring Cancer-related Symptoms in Breast Cancer Survivors</brief_title>
  <official_title>Effects of Bright Light on Co-occurring Cancer-related Symptoms in Breast Cancer Survivors: A Personalized Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Michigan State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Nursing Research (NINR)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Michigan State University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will implement therapeutic bright light that is tailored to the individual's&#xD;
      circadian typology and will estimate its effects on circadian rhythms, 4 common&#xD;
      cancer-associated symptoms, and impact on quality of life in survivors living with cancer.&#xD;
      Examining a selected phase marker (core body temperature) in relation to the associated&#xD;
      clinical features (symptoms) is the starting point for future investigation of the biological&#xD;
      mechanisms of symptoms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this pilot study is to evaluate the feasibility of implementing a home-based,&#xD;
      personalized bright light intervention, and to estimate the effects of bright light on 4&#xD;
      common long-term or late effects of cancer (sleep disturbance, fatigue, depression, cognitive&#xD;
      dysfunction) and on quality of life in post-treatment survivors of breast cancer. The three&#xD;
      specific aims include:&#xD;
&#xD;
      Aim #1: To assess the feasibility of implementing a home-based, personalized bright light&#xD;
      intervention and the proposed data collection plan in post-treatment survivors of breast&#xD;
      cancer.&#xD;
&#xD;
      Aim #2: To estimate the effects of the personalized bright light intervention on sleep&#xD;
      disturbance, fatigue, depression, cognitive dysfunction, and quality of life in survivors of&#xD;
      breast cancer.&#xD;
&#xD;
      Aim #3: To estimate the effects of a personalized bright light intervention on circadian&#xD;
      rhythms in survivors of breast cancer.&#xD;
&#xD;
      The participants of this randomized, controlled pilot study will be randomized to either&#xD;
      30-minute blue-green light therapy at 12,000 lux or dim red light control at 5 lux. Light&#xD;
      will be self-administered using a light visor cap at home for 14 consecutive days. Tailored&#xD;
      to the individual's circadian pattern, light will be delivered either within 30 minutes of&#xD;
      waking in the morning or between 1900-2000 hours in the evening. The nocturnal sleep patterns&#xD;
      will be monitored by all-night in-lab polysomnography; sleep quality, fatigue, depression,&#xD;
      and quality of life will be self-reported; cognition will be objectively assessed before and&#xD;
      after the intervention. Circadian rhythm will be indexed by nocturnal core body temperature&#xD;
      before and after the intervention. Feasibility will be determined by the proportion of&#xD;
      contacted, recruited, and retained subjects, and completeness of the data collected.&#xD;
      Subjective feedback and burden will be assessed at study exit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 6, 2017</start_date>
  <completion_date type="Actual">August 31, 2022</completion_date>
  <primary_completion_date type="Actual">August 31, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of implementing a home-based, personalized bright light intervention</measure>
    <time_frame>Up to 3 weeks from registration</time_frame>
    <description>-The on and off times of each light exposure will be recorded to assess adherence to the treatment protocol</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effects of bright light on sleep disturbance as measured by the PROMIS-Sleep Disturbance</measure>
    <time_frame>Up to 3 weeks from registration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effects of bright light on sleep disturbance as measured by the PSQI</measure>
    <time_frame>Up to 3 weeks from registration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effects of bright light on fatigue as measured by the PROMIS-Cancer-Fatigue</measure>
    <time_frame>Up to 3 weeks from registration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effects of bright light on fatigue as measured by the Daily Log</measure>
    <time_frame>Up to 3 weeks from registration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effects of bright light on depression as measured by the PROMIS-Depression</measure>
    <time_frame>Up to 3 weeks from registration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effects of bright light on depression as measured by the CES-D</measure>
    <time_frame>Up to 3 weeks from registration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effects of bright lights on cognitive dysfunction as measured by the NIH Toolbox Cognition Battery</measure>
    <time_frame>Up to 3 weeks from registration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effects of bright lights on cognitive dysfunction as measured by the MoCA</measure>
    <time_frame>Up to 3 weeks from registration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of bright light on quality of life as measured by the PROMIS-Physical Function</measure>
    <time_frame>Up to 3 weeks from registration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of bright light on quality of life as measured by EORTC QLQ-30</measure>
    <time_frame>Up to 3 weeks from registration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of bright light on circadian rhythms as measured by core body temperature</measure>
    <time_frame>Up to 3 weeks from registration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effects of bright light on level of stress as measured by the PSG</measure>
    <time_frame>Up to 3 weeks from registration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effects of bright light on ambient light exposure as measured by length of exposure x luminous intensity</measure>
    <time_frame>Up to 3 weeks from registration</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">95</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Arm 1: Bright blue-green light</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bright blue-green light (~515nm; 12,000 lux) for 30 minutes once a day.&#xD;
For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.&#xD;
Light therapy will be self-administered using a light visor cap&#xD;
Each participant will make (3) overnight visits to the sleep laboratory&#xD;
On 2 randomly selected days, the participants will wear a light meter during wake time</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2: Dim red light</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Dim red light (5 lux) (control group) for 30 minutes once a day.&#xD;
--For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.&#xD;
Light therapy will be self-administered using a light visor cap&#xD;
Each participant will make (3) overnight visits to the sleep laboratory --On 2 randomly selected days, the participants will wear a light meter during wake time</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Polysomnography (PSG)</intervention_name>
    <description>Sleep patterns will be measured by in-lab PSG following a standardized protocol. 10mm silver/silver chloride electroencephalogram (EEG) and electromyography (EMG) electrodes and 11mm silver/silver chloride electroculography (EOG) electrodes will be connected to a Nihon Kohden system, 912 model (Nihon Kohden, Irvine, CA). A standard sleep montage following the 10/20 procedure for electrode placement, left and right electrooculography referenced to the opposite mastoid and mentalis electromyography will be followed. Data will be visually scored by a polysomnographer blind to study conditions following the American Academy of Sleep Medicine (AASM) Manual.</description>
    <arm_group_label>Arm 1: Bright blue-green light</arm_group_label>
    <arm_group_label>Arm 2: Dim red light</arm_group_label>
    <other_name>PSG</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Rectal thermistor 400 Series</intervention_name>
    <description>Nocturnal core body temperature will be measured using a rectal thermistor 400 series manufactured by YSI (Yellow Springs, OH, USA) inserted up to a depth of 7 cm. and taped in place. The thermistor will be connected to a Model 4600 thermometer (YSI, Yellow Springs, OH, USA) that will be interfaced with the PSG via cabling. Core temperature readings will be continuously monitored and recorded every 5 minutes during the all-night sleep studies.</description>
    <arm_group_label>Arm 1: Bright blue-green light</arm_group_label>
    <arm_group_label>Arm 2: Dim red light</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Bright blue-green light</intervention_name>
    <description>-The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect</description>
    <arm_group_label>Arm 1: Bright blue-green light</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dim red light</intervention_name>
    <description>-The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect</description>
    <arm_group_label>Arm 2: Dim red light</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Digital foot candle datalogging light meter</intervention_name>
    <description>On 2 random days during the 2-week bright light treatment, ambient light will be recorded continuously during waking hours using a digital foot candle datalogging light meter (Extech Instruments, Waltham, MA) Model SDL400. The 7.1&quot; x 2.9&quot; x 1.0&quot; light meter (12.21 oz) has the capacity to measure up to 10,000 footcandles (accuracy: ± 4% reading). The light-weight light sensor is approximately 2 inches in diameter and comes with a clip and strap that makes it comfortable to wear just below the neck.</description>
    <arm_group_label>Arm 1: Bright blue-green light</arm_group_label>
    <arm_group_label>Arm 2: Dim red light</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer-Fatigue</intervention_name>
    <description>8 items with a 5-point rating scale (1=not at all to 5 =very much) measuring fatigue experience and fatigue impact. Higher scores indicate worse fatigue. PROMIS-Fatigue was developed based on rigorous methodologies. The psychometric properties have been established across chronic illnesses including cancer.</description>
    <arm_group_label>Arm 1: Bright blue-green light</arm_group_label>
    <arm_group_label>Arm 2: Dim red light</arm_group_label>
    <other_name>PROMIS-Cancer-Fatigue</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep Disturbance</intervention_name>
    <description>8 items with 5-point rating scales measuring overall sleep and sleep-related impairments. Higher scores indicate worse sleep disturbances. Validity was supported by moderate to high correlations with the existing scales, e.g. PSQI, Epworth Sleepiness Scale (ESS). The scores significantly differed participants with and without sleep disorders.</description>
    <arm_group_label>Arm 1: Bright blue-green light</arm_group_label>
    <arm_group_label>Arm 2: Dim red light</arm_group_label>
    <other_name>PROMIS-Sleep Disturbance</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Patient-Reported Outcomes Measurement Information System (PROMIS)-Depression</intervention_name>
    <description>8 items with 5-point rating scales (1=never to 5=always) measuring affective and cognitive manifestations of depressive mood. Higher scores indicate worse depression. In a sample of depressed outpatients, PROMIS-Depression showed greater reliability when compared to the CES-D and the Patient Health Questionnaire (PHQ-9). Convergent validity with the CES-D and PHQ-9 was supported by strong correlations, ranged 0.72 to 0.84</description>
    <arm_group_label>Arm 1: Bright blue-green light</arm_group_label>
    <arm_group_label>Arm 2: Dim red light</arm_group_label>
    <other_name>PROMIS-Depression</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Patient-Reported Outcomes Measurement Information System (PROMIS)-Physical Function</intervention_name>
    <description>8 items with 5-point rating scales measuring the individual's ability to complete daily activities. Higher scores indicate worse functioning. Validity was tested in 1,415 adults with diverse clinical conditions. The PROMIS Physical Function scores corresponded to the expected positive or negative changes in the individual's physical function.</description>
    <arm_group_label>Arm 1: Bright blue-green light</arm_group_label>
    <arm_group_label>Arm 2: Dim red light</arm_group_label>
    <other_name>PROMIS-Physical Function</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pittsburgh Sleep Quality Index (PSQI)</intervention_name>
    <description>19 self-report items measuring sleep quality, latency, duration, efficiency, disturbance, medication use, and daytime dysfunction. Each item is rated on a 0-3 rating scale. The global PSQI score ranges 0-21, with higher scores indicating more severe sleep disturbance. A global PSQI score greater than 5 was found to have a sensitivity of 89.6% and a specificity of 86.5% in differentiating good and poor sleepers.</description>
    <arm_group_label>Arm 1: Bright blue-green light</arm_group_label>
    <arm_group_label>Arm 2: Dim red light</arm_group_label>
    <other_name>PSQI</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Center for Epidemiological Studies - Depression</intervention_name>
    <description>20-item self-report instrument commonly used to measure depressive symptoms in cancer patients. Each item is rated on a 4-point rating scale (0=rarely or none of the time to 3=all of the time) describing the frequency of occurrence during the past week. Score can range from 0-60, with higher scores indicating more depressive symptoms.</description>
    <arm_group_label>Arm 1: Bright blue-green light</arm_group_label>
    <arm_group_label>Arm 2: Dim red light</arm_group_label>
    <other_name>CES-D</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Montreal Cognitive Assessment (MoCA)</intervention_name>
    <description>The MoCA is highly sensitive for screening patient with mild cognitive impairment. The MoCA is a 30-point scale with 7 cognitive subtests: visuo-executive, naming, attention, language, abstraction, delayed recall, and orientation. It scores from 0 to 30, where higher scores indicate better cognition and a score below 26 indicates cognitive impairment. The MoCA is highly sensitive for screening patient with mild cognitive impairment.</description>
    <arm_group_label>Arm 1: Bright blue-green light</arm_group_label>
    <arm_group_label>Arm 2: Dim red light</arm_group_label>
    <other_name>MoCA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire (EORTC QLQ-C30)</intervention_name>
    <description>The EORTC QLQ-C30 consists of 30 items with a 4-point rating scale (1=not at all to 4=very much) measuring functioning, symptom intensity, and global health status/quality of life during the past week.</description>
    <arm_group_label>Arm 1: Bright blue-green light</arm_group_label>
    <arm_group_label>Arm 2: Dim red light</arm_group_label>
    <other_name>EORTC QLQ-C30</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Daily Log</intervention_name>
    <description>-A log where the participants will indicate date, wake time, sleep time answer 3 questions regarding the previous nights sleep (answers range from 1=not at all to 5=very much), have an area to indicate if naps occurred during the day, and 2 questions about fatigue &amp; sleepiness (answers ranging from 0=no fatigue/sleepiness to 10=worst fatigue/sleepiness</description>
    <arm_group_label>Arm 1: Bright blue-green light</arm_group_label>
    <arm_group_label>Arm 2: Dim red light</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Females&#xD;
&#xD;
          -  21 years of age or older 1-3 years post-completion of chemotherapy or/and radiation&#xD;
             therapy for stage I-III breast cancer&#xD;
&#xD;
          -  Experience ≥ 2 concurrent symptoms (fatigue, sleep disruption, depressive symptoms,&#xD;
             and/or cognitive dysfunction as measured by 4 screening instruments)&#xD;
&#xD;
          -  Be either phase advanced or delayed (morning or evening types by the Horne-Ostberg&#xD;
             Morningness-Eveningness Questionnaire (MEQ) ≥59 or ≤41)&#xD;
&#xD;
          -  Sighted&#xD;
&#xD;
          -  Mentally competent to consent&#xD;
&#xD;
          -  Able to understand English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Undergoing cancer treatment for another malignancy&#xD;
&#xD;
          -  Have metastatic cancer&#xD;
&#xD;
          -  Engaged in shift work or travel across more than three time zones within 2 weeks prior&#xD;
             to study&#xD;
&#xD;
          -  Current diagnosis of seasonal affective disorder or substance abuse Current diagnosis&#xD;
             of major Axis I psychiatric disorders (e.g. depressive disorders), neurological&#xD;
             impairments, or muscular dystrophies&#xD;
&#xD;
          -  Report severe depressive mood (Center for Epidemiological Studies Depression Scale&#xD;
             (CES-D) &gt;24)&#xD;
&#xD;
          -  Take prescribed sedative hypnotics or steroids Have eye conditions (glaucoma or&#xD;
             retinal disease), problems triggered by bright light (e.g., migraine), or take&#xD;
             photosensitizing medications (e.g., some porphyrin drugs, antipsychotics,&#xD;
             antiarrhythmic agents)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Horng-Shiuann Wu, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Michigan State University College of Nursing</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Michigan State University</name>
      <address>
        <city>East Lansing</city>
        <state>Michigan</state>
        <zip>48824</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.siteman.wustl.edu</url>
    <description>Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine</description>
  </link>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>October 3, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <last_update_submitted>September 8, 2022</last_update_submitted>
  <last_update_submitted_qc>September 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Michigan State University</investigator_affiliation>
    <investigator_full_name>Horng-Shiuann Wu</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03304587
org study id: 201703147
secondary id: 1R15NR016828-01A1
nct id: NCT03304587
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
This study will implement therapeutic bright light that is tailored to the individual's
      circadian typology and will estimate its effects on circadian rhythms, 4 common
      cancer-associated symptoms, and impact on quality of life in survivors living with cancer.
      Examining a selected phase marker (core body temperature) in relation to the associated
      clinical features (symptoms) is the starting point for future investigation of the biological
      mechanisms of symptoms.
The purpose of this pilot study is to evaluate the feasibility of implementing a home-based,
      personalized bright light intervention, and to estimate the effects of bright light on 4
      common long-term or late effects of cancer (sleep disturbance, fatigue, depression, cognitive
      dysfunction) and on quality of life in post-treatment survivors of breast cancer. The three
      specific aims include:

      Aim #1: To assess the feasibility of implementing a home-based, personalized bright light
      intervention and the proposed data collection plan in post-treatment survivors of breast
      cancer.

      Aim #2: To estimate the effects of the personalized bright light intervention on sleep
      disturbance, fatigue, depression, cognitive dysfunction, and quality of life in survivors of
      breast cancer.

      Aim #3: To estimate the effects of a personalized bright light intervention on circadian
      rhythms in survivors of breast cancer.

      The participants of this randomized, controlled pilot study will be randomized to either
      30-minute blue-green light therapy at 12,000 lux or dim red light control at 5 lux. Light
      will be self-administered using a light visor cap at home for 14 consecutive days. Tailored
      to the individual's circadian pattern, light will be delivered either within 30 minutes of
      waking in the morning or between 1900-2000 hours in the evening. The nocturnal sleep patterns
      will be monitored by all-night in-lab polysomnography; sleep quality, fatigue, depression,
      and quality of life will be self-reported; cognition will be objectively assessed before and
      after the intervention. Circadian rhythm will be indexed by nocturnal core body temperature
      before and after the intervention. Feasibility will be determined by the proportion of
      contacted, recruited, and retained subjects, and completeness of the data collected.
      Subjective feedback and burden will be assessed at study exit.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Feasibility of implementing a home-based, personalized bright light intervention
time frame: Up to 3 weeks from registration
description: -The on and off times of each light exposure will be recorded to assess adherence to the treatment protocol
measure: Effects of bright light on sleep disturbance as measured by the PROMIS-Sleep Disturbance
time frame: Up to 3 weeks from registration
measure: Effects of bright light on sleep disturbance as measured by the PSQI
time frame: Up to 3 weeks from registration
measure: Effects of bright light on fatigue as measured by the PROMIS-Cancer-Fatigue
time frame: Up to 3 weeks from registration
measure: Effects of bright light on fatigue as measured by the Daily Log
time frame: Up to 3 weeks from registration
measure: Effects of bright light on depression as measured by the PROMIS-Depression
time frame: Up to 3 weeks from registration
measure: Effects of bright light on depression as measured by the CES-D
time frame: Up to 3 weeks from registration
measure: Effects of bright lights on cognitive dysfunction as measured by the NIH Toolbox Cognition Battery
time frame: Up to 3 weeks from registration
measure: Effects of bright lights on cognitive dysfunction as measured by the MoCA
time frame: Up to 3 weeks from registration
measure: Effect of bright light on quality of life as measured by the PROMIS-Physical Function
time frame: Up to 3 weeks from registration
measure: Effect of bright light on quality of life as measured by EORTC QLQ-30
time frame: Up to 3 weeks from registration
measure: Effect of bright light on circadian rhythms as measured by core body temperature
time frame: Up to 3 weeks from registration
measure: Effects of bright light on level of stress as measured by the PSG
time frame: Up to 3 weeks from registration
measure: Effects of bright light on ambient light exposure as measured by length of exposure x luminous intensity
time frame: Up to 3 weeks from registration
arm group label: Arm 1: Bright blue-green light
arm group type: Experimental
description: Bright blue-green light (~515nm; 12,000 lux) for 30 minutes once a day.
For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.
Light therapy will be self-administered using a light visor cap
Each participant will make (3) overnight visits to the sleep laboratory
On 2 randomly selected days, the participants will wear a light meter during wake time
arm group label: Arm 2: Dim red light
arm group type: Active Comparator
description: Dim red light (5 lux) (control group) for 30 minutes once a day.
--For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.
Light therapy will be self-administered using a light visor cap
Each participant will make (3) overnight visits to the sleep laboratory --On 2 randomly selected days, the participants will wear a light meter during wake time
intervention type: Diagnostic Test
intervention name: Polysomnography (PSG)
description: Sleep patterns will be measured by in-lab PSG following a standardized protocol. 10mm silver/silver chloride electroencephalogram (EEG) and electromyography (EMG) electrodes and 11mm silver/silver chloride electroculography (EOG) electrodes will be connected to a Nihon Kohden system, 912 model (Nihon Kohden, Irvine, CA). A standard sleep montage following the 10/20 procedure for electrode placement, left and right electrooculography referenced to the opposite mastoid and mentalis electromyography will be followed. Data will be visually scored by a polysomnographer blind to study conditions following the American Academy of Sleep Medicine (AASM) Manual.
arm group label: Arm 1: Bright blue-green light
arm group label: Arm 2: Dim red light
other name: PSG
intervention type: Diagnostic Test
intervention name: Rectal thermistor 400 Series
description: Nocturnal core body temperature will be measured using a rectal thermistor 400 series manufactured by YSI (Yellow Springs, OH, USA) inserted up to a depth of 7 cm. and taped in place. The thermistor will be connected to a Model 4600 thermometer (YSI, Yellow Springs, OH, USA) that will be interfaced with the PSG via cabling. Core temperature readings will be continuously monitored and recorded every 5 minutes during the all-night sleep studies.
arm group label: Arm 1: Bright blue-green light
arm group label: Arm 2: Dim red light
intervention type: Other
intervention name: Bright blue-green light
description: -The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
arm group label: Arm 1: Bright blue-green light
intervention type: Other
intervention name: Dim red light
description: -The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
arm group label: Arm 2: Dim red light
intervention type: Diagnostic Test
intervention name: Digital foot candle datalogging light meter
description: On 2 random days during the 2-week bright light treatment, ambient light will be recorded continuously during waking hours using a digital foot candle datalogging light meter (Extech Instruments, Waltham, MA) Model SDL400. The 7.1" x 2.9" x 1.0" light meter (12.21 oz) has the capacity to measure up to 10,000 footcandles (accuracy: ± 4% reading). The light-weight light sensor is approximately 2 inches in diameter and comes with a clip and strap that makes it comfortable to wear just below the neck.
arm group label: Arm 1: Bright blue-green light
arm group label: Arm 2: Dim red light
intervention type: Other
intervention name: Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer-Fatigue
description: 8 items with a 5-point rating scale (1=not at all to 5 =very much) measuring fatigue experience and fatigue impact. Higher scores indicate worse fatigue. PROMIS-Fatigue was developed based on rigorous methodologies. The psychometric properties have been established across chronic illnesses including cancer.
arm group label: Arm 1: Bright blue-green light
arm group label: Arm 2: Dim red light
other name: PROMIS-Cancer-Fatigue
intervention type: Other
intervention name: Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep Disturbance
description: 8 items with 5-point rating scales measuring overall sleep and sleep-related impairments. Higher scores indicate worse sleep disturbances. Validity was supported by moderate to high correlations with the existing scales, e.g. PSQI, Epworth Sleepiness Scale (ESS). The scores significantly differed participants with and without sleep disorders.
arm group label: Arm 1: Bright blue-green light
arm group label: Arm 2: Dim red light
other name: PROMIS-Sleep Disturbance
intervention type: Other
intervention name: Patient-Reported Outcomes Measurement Information System (PROMIS)-Depression
description: 8 items with 5-point rating scales (1=never to 5=always) measuring affective and cognitive manifestations of depressive mood. Higher scores indicate worse depression. In a sample of depressed outpatients, PROMIS-Depression showed greater reliability when compared to the CES-D and the Patient Health Questionnaire (PHQ-9). Convergent validity with the CES-D and PHQ-9 was supported by strong correlations, ranged 0.72 to 0.84
arm group label: Arm 1: Bright blue-green light
arm group label: Arm 2: Dim red light
other name: PROMIS-Depression
intervention type: Other
intervention name: Patient-Reported Outcomes Measurement Information System (PROMIS)-Physical Function
description: 8 items with 5-point rating scales measuring the individual's ability to complete daily activities. Higher scores indicate worse functioning. Validity was tested in 1,415 adults with diverse clinical conditions. The PROMIS Physical Function scores corresponded to the expected positive or negative changes in the individual's physical function.
arm group label: Arm 1: Bright blue-green light
arm group label: Arm 2: Dim red light
other name: PROMIS-Physical Function
intervention type: Other
intervention name: Pittsburgh Sleep Quality Index (PSQI)
description: 19 self-report items measuring sleep quality, latency, duration, efficiency, disturbance, medication use, and daytime dysfunction. Each item is rated on a 0-3 rating scale. The global PSQI score ranges 0-21, with higher scores indicating more severe sleep disturbance. A global PSQI score greater than 5 was found to have a sensitivity of 89.6% and a specificity of 86.5% in differentiating good and poor sleepers.
arm group label: Arm 1: Bright blue-green light
arm group label: Arm 2: Dim red light
other name: PSQI
intervention type: Other
intervention name: Center for Epidemiological Studies - Depression
description: 20-item self-report instrument commonly used to measure depressive symptoms in cancer patients. Each item is rated on a 4-point rating scale (0=rarely or none of the time to 3=all of the time) describing the frequency of occurrence during the past week. Score can range from 0-60, with higher scores indicating more depressive symptoms.
arm group label: Arm 1: Bright blue-green light
arm group label: Arm 2: Dim red light
other name: CES-D
intervention type: Other
intervention name: Montreal Cognitive Assessment (MoCA)
description: The MoCA is highly sensitive for screening patient with mild cognitive impairment. The MoCA is a 30-point scale with 7 cognitive subtests: visuo-executive, naming, attention, language, abstraction, delayed recall, and orientation. It scores from 0 to 30, where higher scores indicate better cognition and a score below 26 indicates cognitive impairment. The MoCA is highly sensitive for screening patient with mild cognitive impairment.
arm group label: Arm 1: Bright blue-green light
arm group label: Arm 2: Dim red light
other name: MoCA
intervention type: Other
intervention name: European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire (EORTC QLQ-C30)
description: The EORTC QLQ-C30 consists of 30 items with a 4-point rating scale (1=not at all to 4=very much) measuring functioning, symptom intensity, and global health status/quality of life during the past week.
arm group label: Arm 1: Bright blue-green light
arm group label: Arm 2: Dim red light
other name: EORTC QLQ-C30
intervention type: Other
intervention name: Daily Log
description: -A log where the participants will indicate date, wake time, sleep time answer 3 questions regarding the previous nights sleep (answers range from 1=not at all to 5=very much), have an area to indicate if naps occurred during the day, and 2 questions about fatigue & sleepiness (answers ranging from 0=no fatigue/sleepiness to 10=worst fatigue/sleepiness
arm group label: Arm 1: Bright blue-green light
arm group label: Arm 2: Dim red light
criteria: 
gender: Female
minimum age: 21 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Horng-Shiuann Wu, PhD
role: Study Chair
affiliation: Michigan State University College of Nursing
facility: 
country: United States
url: http://www.siteman.wustl.edu
description: Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
responsible party type: Principal Investigator
investigator affiliation: Michigan State University
investigator full name: Horng-Shiuann Wu
investigator title: Associate Professor
mesh term: Breast Neoplasms
sharing ipd: No