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Effects of Bright Light on Co-occurring Cancer-related Symptoms in Breast Cancer Survivors

This study is currently recruiting participants.
Verified November 2017 by Washington University School of Medicine
Sponsor:
ClinicalTrials.gov Identifier:
NCT03304587
First Posted: October 9, 2017
Last Update Posted: November 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Goldfarb School of Nursing at Barnes-Jewish College
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Washington University School of Medicine
  Purpose
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.

Condition Intervention Phase
Breast Cancer Diagnostic Test: Polysomnography (PSG) Diagnostic Test: Rectal thermistor 400 Series Other: Bright blue-green light Other: Dim red light Diagnostic Test: Digital foot candle datalogging light meter Other: Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer-Fatigue Other: Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep Disturbance Other: Patient-Reported Outcomes Measurement Information System (PROMIS)-Depression Other: Patient-Reported Outcomes Measurement Information System (PROMIS)-Physical Function Other: Pittsburgh Sleep Quality Index (PSQI) Other: Center for Epidemiological Studies - Depression Other: Montreal Cognitive Assessment (MoCA) Other: European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire (EORTC QLQ-C30) Other: Daily Log Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of Bright Light on Co-occurring Cancer-related Symptoms in Breast Cancer Survivors: A Personalized Intervention

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Feasibility of implementing a home-based, personalized bright light intervention [ Time Frame: Up to 3 weeks from registration ]
    -The on and off times of each light exposure will be recorded to assess adherence to the treatment protocol


Secondary Outcome Measures:
  • Effects of bright light on sleep disturbance as measured by the PROMIS-Sleep Disturbance [ Time Frame: Up to 3 weeks from registration ]
  • Effects of bright light on sleep disturbance as measured by the PSQI [ Time Frame: Up to 3 weeks from registration ]
  • Effects of bright light on fatigue as measured by the PROMIS-Cancer-Fatigue [ Time Frame: Up to 3 weeks from registration ]
  • Effects of bright light on fatigue as measured by the Daily Log [ Time Frame: Up to 3 weeks from registration ]
  • Effects of bright light on depression as measured by the PROMIS-Depression [ Time Frame: Up to 3 weeks from registration ]
  • Effects of bright light on depression as measured by the CES-D [ Time Frame: Up to 3 weeks from registration ]
  • Effects of bright lights on cognitive dysfunction as measured by the NIH Toolbox Cognition Battery [ Time Frame: Up to 3 weeks from registration ]
  • Effects of bright lights on cognitive dysfunction as measured by the MoCA [ Time Frame: Up to 3 weeks from registration ]
  • Effect of bright light on quality of life as measured by the PROMIS-Physical Function [ Time Frame: Up to 3 weeks from registration ]
  • Effect of bright light on quality of life as measured by EORTC QLQ-30 [ Time Frame: Up to 3 weeks from registration ]
  • Effect of bright light on circadian rhythms as measured by core body temperature [ Time Frame: Up to 3 weeks from registration ]
  • Effects of bright light on level of stress as measured by the PSG [ Time Frame: Up to 3 weeks from registration ]
  • 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 ]

Estimated Enrollment: 60
Actual Study Start Date: November 6, 2017
Estimated Study Completion Date: November 30, 2020
Estimated Primary Completion Date: November 30, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: Bright blue-green light
  • 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
Diagnostic Test: Polysomnography (PSG)
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.
Other Name: PSG
Diagnostic Test: Rectal thermistor 400 Series
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.
Other: Bright blue-green light
-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
Diagnostic Test: Digital foot candle datalogging light meter
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.
Other: Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer-Fatigue
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.
Other Name: PROMIS-Cancer-Fatigue
Other: Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep Disturbance
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.
Other Name: PROMIS-Sleep Disturbance
Other: Patient-Reported Outcomes Measurement Information System (PROMIS)-Depression
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
Other Name: PROMIS-Depression
Other: Patient-Reported Outcomes Measurement Information System (PROMIS)-Physical Function
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.
Other Name: PROMIS-Physical Function
Other: Pittsburgh Sleep Quality Index (PSQI)
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.
Other Name: PSQI
Other: Center for Epidemiological Studies - Depression
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.
Other Name: CES-D
Other: Montreal Cognitive Assessment (MoCA)
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.
Other Name: MoCA
Other: European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire (EORTC QLQ-C30)
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.
Other Name: EORTC QLQ-C30
Other: Daily Log
-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
Active Comparator: Arm 2: Dim red light
  • 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
Diagnostic Test: Polysomnography (PSG)
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.
Other Name: PSG
Diagnostic Test: Rectal thermistor 400 Series
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.
Other: Dim red light
-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
Diagnostic Test: Digital foot candle datalogging light meter
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.
Other: Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer-Fatigue
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.
Other Name: PROMIS-Cancer-Fatigue
Other: Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep Disturbance
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.
Other Name: PROMIS-Sleep Disturbance
Other: Patient-Reported Outcomes Measurement Information System (PROMIS)-Depression
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
Other Name: PROMIS-Depression
Other: Patient-Reported Outcomes Measurement Information System (PROMIS)-Physical Function
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.
Other Name: PROMIS-Physical Function
Other: Pittsburgh Sleep Quality Index (PSQI)
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.
Other Name: PSQI
Other: Center for Epidemiological Studies - Depression
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.
Other Name: CES-D
Other: Montreal Cognitive Assessment (MoCA)
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.
Other Name: MoCA
Other: European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire (EORTC QLQ-C30)
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.
Other Name: EORTC QLQ-C30
Other: Daily Log
-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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Females
  • 21 years of age or older 1-3 years post-completion of chemotherapy or/and radiation therapy for stage I-III breast cancer
  • Experience ≥ 2 concurrent symptoms (fatigue, sleep disruption, depressive symptoms, and/or cognitive dysfunction as measured by 4 screening instruments)
  • Be either phase advanced or delayed (morning or evening types by the Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ) ≥59 or ≤41)
  • Sighted
  • Mentally competent to consent
  • Able to understand English.

Exclusion Criteria:

  • Undergoing cancer treatment for another malignancy
  • Have metastatic cancer
  • Engaged in shift work or travel across more than three time zones within 2 weeks prior to study
  • Current diagnosis of seasonal affective disorder or substance abuse Current diagnosis of major Axis I psychiatric disorders (e.g. depressive disorders), neurological impairments, or muscular dystrophies
  • Report severe depressive mood (Center for Epidemiological Studies Depression Scale (CES-D) >24)
  • Take prescribed sedative hypnotics or steroids Have eye conditions (glaucoma or retinal disease), problems triggered by bright light (e.g., migraine), or take photosensitizing medications (e.g., some porphyrin drugs, antipsychotics, antiarrhythmic agents)
  Contacts and Locations
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): NCT03304587


Contacts
Contact: Horng-Shiuann Wu, Ph.D., RN 314-454-8929 hxw0198@bjc.org

Locations
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Horng-Shiuann Wu, Ph.D., RN    314-454-8929    hxw0198@bjc.org   
Principal Investigator: Horng-Shiuann Wu, Ph.D., RN         
Sub-Investigator: Jean E Davis, Ph.D., RN, FAAN         
Sub-Investigator: Cynthia X Ma, M.D., Ph.D.         
Sub-Investigator: Feng Gao, M.D., Ph.D.         
Sponsors and Collaborators
Washington University School of Medicine
Goldfarb School of Nursing at Barnes-Jewish College
National Institute of Nursing Research (NINR)
Investigators
Study Chair: Horng-Shiuann Wu, Ph.D., RN Washington University School of Medicine
  More Information

Additional Information:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03304587     History of Changes
Other Study ID Numbers: 201703147
1R15NR016828-01A1 ( U.S. NIH Grant/Contract )
First Submitted: October 3, 2017
First Posted: October 9, 2017
Last Update Posted: November 9, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases