Bright Light on Fatigue in Women Being Treated for Breast Cancer
NCT ID: NCT02658708
Last Updated: 2017-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
19 participants
INTERVENTIONAL
2015-10-12
2017-05-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1: Bright blue-green light
Complete the MEQ at screening, the day before 2nd cycle of chemo, and on the day of 3rd cycle of chemo, -21 day light intervention at home for 30 min once a day during 2nd cycle of chemo, Scores of ≤41 (evening types) on MEQ will have light delivered within 30 minutes of waking for 21 consecutive mornings. Score of ≥59 (morning types) on MEQ will have light delivered between 1900-2000 hours for 21 consecutive evenings. Light therapy will be self-administered using a light visor cap. On 2 randomly selected days ambient light will be recorded continuously during waking hours using a digital foot candle datalogging light meter, Continuous ambulatory PSG for 24 hours at the participant's home before and after the light intervention, Complete the fatigue and sleep log on a daily basis and two visual analog scales (VAS) (diurnal fatigue and daytime sleepiness) within half an hour upon awakening, at 1200 hours, 1600 hours, 2000 hours, and within half an hour before going to bed
Bright blue-green light using light visor cap
European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire
-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
Epworth Sleepiness Scale
-Consists of 8 common daily activities with a 4-point rating scale (0=would never doze to 3=a high chance of dozing) measuring usual daytime sleepiness over a recent time period
Pittsburgh Sleep Quality Index
-Contains 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
Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep Disturbance
-Consists of 8 items with 5-point rating scales measuring overall sleep and sleep-related impairments. Higher scores indicate worse sleep disturbances
Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer-Fatigue
-Consists of 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.
Digital foot candle datalogging light meter (Extech Instrument, Model SDL400)
-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.
Polysomnography (Easy Ambulatory 2 Cadwell, Kennewick, WA)
-A standard sleep montage of electroencephalography following the 10/20 procedure for electrode placement, left and right electrooculography referenced to the opposite mastoid and mentalis electromyography will be followed
Horne-Ostberg Morningness-Eveningness Questionnaire
Daily Fatigue and Sleep Log
* Two visual analog scales (VAS) for diurnal fatigue and daytime sleepiness
* Two 0-10 point rating scales (average and worst fatigue levels in 24 hours)
Arm 2: Dim red light
Complete the MEQ at screening, the day before 2nd cycle of chemo, and on the day of 3rd cycle of chemo, 21 day light intervention at home for 30 min once a day during 2nd cycle of chemo, Scores of ≤41 (evening types) on MEQ will have light delivered within 30 minutes of waking for 21 consecutive mornings. Score of ≥59 (morning types) on MEQ will have light delivered between 1900-2000 hours for 21 consecutive evenings. Light therapy will be self-administered using a light visor cap. On 2 days randomly selected days ambient light will be recorded continuously during waking hours using a digital foot candle datalogging light meter, Continuous ambulatory PSG for 24 hours at the participant's home before and after the light intervention, Complete the fatigue and sleep log on a daily basis and two visual analog scales (VAS) (diurnal fatigue and daytime sleepiness) within half an hour upon awakening, at 1200 hours, 1600 hours, 2000 hours, and within half an hour before going to bed
Dim red light using light visor cap
European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire
-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
Epworth Sleepiness Scale
-Consists of 8 common daily activities with a 4-point rating scale (0=would never doze to 3=a high chance of dozing) measuring usual daytime sleepiness over a recent time period
Pittsburgh Sleep Quality Index
-Contains 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
Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep Disturbance
-Consists of 8 items with 5-point rating scales measuring overall sleep and sleep-related impairments. Higher scores indicate worse sleep disturbances
Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer-Fatigue
-Consists of 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.
Digital foot candle datalogging light meter (Extech Instrument, Model SDL400)
-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.
Polysomnography (Easy Ambulatory 2 Cadwell, Kennewick, WA)
-A standard sleep montage of electroencephalography following the 10/20 procedure for electrode placement, left and right electrooculography referenced to the opposite mastoid and mentalis electromyography will be followed
Horne-Ostberg Morningness-Eveningness Questionnaire
Daily Fatigue and Sleep Log
* Two visual analog scales (VAS) for diurnal fatigue and daytime sleepiness
* Two 0-10 point rating scales (average and worst fatigue levels in 24 hours)
Interventions
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Bright blue-green light using light visor cap
Dim red light using light visor cap
European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire
-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
Epworth Sleepiness Scale
-Consists of 8 common daily activities with a 4-point rating scale (0=would never doze to 3=a high chance of dozing) measuring usual daytime sleepiness over a recent time period
Pittsburgh Sleep Quality Index
-Contains 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
Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep Disturbance
-Consists of 8 items with 5-point rating scales measuring overall sleep and sleep-related impairments. Higher scores indicate worse sleep disturbances
Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer-Fatigue
-Consists of 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.
Digital foot candle datalogging light meter (Extech Instrument, Model SDL400)
-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.
Polysomnography (Easy Ambulatory 2 Cadwell, Kennewick, WA)
-A standard sleep montage of electroencephalography following the 10/20 procedure for electrode placement, left and right electrooculography referenced to the opposite mastoid and mentalis electromyography will be followed
Horne-Ostberg Morningness-Eveningness Questionnaire
Daily Fatigue and Sleep Log
* Two visual analog scales (VAS) for diurnal fatigue and daytime sleepiness
* Two 0-10 point rating scales (average and worst fatigue levels in 24 hours)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Newly diagnosed with stage I-III breast cancer
* Scheduled to receive 21-day cycles of intravenous chemotherapy
* Experiencing disrupted sleep (determined by Pittsburgh Sleep Quality Index)
* Morning or evening types (determined by Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ)
* Sighted
* Mentally competent to consent
* Able to under English
Exclusion Criteria
* Undergoing other cancer treatments
* Engage in shift work or travel across more than 3 time zones within 2 weeks prior to study
* Known history of seasonal affective disorder or substance abuse
* Current diagnosis of major Axis I psychiatric disorders, neurological impairments, or muscular dystrophies
* Regularly use steroid or other immunosuppressive medications
* Take prescribed sedative hypnotics or sleep medications because these conditions may affect fatigue and/or sleep/wake patterns.
* 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)
21 Years
FEMALE
No
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Horng-Shiuann Wu, Ph.D., R.N.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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References
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Wu HS, Davis JE, Chen L. Bright light shows promise in improving sleep, depression, and quality of life in women with breast cancer during chemotherapy: findings of a pilot study. Chronobiol Int. 2021 May;38(5):694-704. doi: 10.1080/07420528.2021.1871914. Epub 2021 Jan 21.
Related Links
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Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
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201503075
Identifier Type: -
Identifier Source: org_study_id