Bright Light on Fatigue in Women Being Treated for Breast Cancer

Study Overview
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Brief Summary
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This proposed study will examine feasibility and implement therapeutic bright light that is tailored to the individual's circadian typology to estimate its therapeutic effects on sleep/wake patterns and fatigue in breast cancer patients undergoing chemotherapy.

Official Title
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Bright Light on Fatigue in Women Being Treated for Breast Cancer: A Pilot Study

Conditions
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Breast Neoplasms, Breast Cancer, Cancer of Breast, Cancer of the Breast

Intervention / Treatment
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* Other: Bright blue-green light using light visor cap
* Other: Dim red light using light visor cap
* Other: European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire
* Other: Epworth Sleepiness Scale
* Other: Pittsburgh Sleep Quality Index
* Other: Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep Disturbance
* Other: Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer-Fatigue
* Diagnostic Test: Digital foot candle datalogging light meter (Extech Instrument, Model SDL400)
* Diagnostic Test: Polysomnography (Easy Ambulatory 2 Cadwell, Kennewick, WA)
* Other: Horne-Ostberg Morningness-Eveningness Questionnaire
* Other: Daily Fatigue and Sleep Log


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 21 years of age or older 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: Concurrent malignancy 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)

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: Bright blue-green light<br>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 | Other: Bright blue-green light using light visor cap<br> <br> Other: European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire<br>* -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<br>* Other names: EORCT QLQ C-30;Other: Epworth Sleepiness Scale<br>* -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<br>* Other names: ESS;Other: Pittsburgh Sleep Quality Index<br>* -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<br>* Other names: PSQI;Other: Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep Disturbance<br>* -Consists of 8 items with 5-point rating scales measuring overall sleep and sleep-related impairments. Higher scores indicate worse sleep disturbances<br>Other: Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer-Fatigue<br>* -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.<br>Diagnostic Test: Digital foot candle datalogging light meter (Extech Instrument, Model SDL400)<br>* -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.<br>Diagnostic Test: Polysomnography (Easy Ambulatory 2 Cadwell, Kennewick, WA)<br>* -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<br>* Other names: PSG;Other: Horne-Ostberg Morningness-Eveningness Questionnaire<br> <br> * Other names: MEQ;Other: Daily Fatigue and Sleep Log<br>* 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)<br>|
| Active Comparator: Arm 2: Dim red light<br>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 | Other: Dim red light using light visor cap<br> <br> Other: European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire<br>* -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<br>* Other names: EORCT QLQ C-30;Other: Epworth Sleepiness Scale<br>* -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<br>* Other names: ESS;Other: Pittsburgh Sleep Quality Index<br>* -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<br>* Other names: PSQI;Other: Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep Disturbance<br>* -Consists of 8 items with 5-point rating scales measuring overall sleep and sleep-related impairments. Higher scores indicate worse sleep disturbances<br>Other: Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer-Fatigue<br>* -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.<br>Diagnostic Test: Digital foot candle datalogging light meter (Extech Instrument, Model SDL400)<br>* -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.<br>Diagnostic Test: Polysomnography (Easy Ambulatory 2 Cadwell, Kennewick, WA)<br>* -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<br>* Other names: PSG;Other: Horne-Ostberg Morningness-Eveningness Questionnaire<br> <br> * Other names: MEQ;Other: Daily Fatigue and Sleep Log<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of implementing a bright light intervention as measured by estimating completion of scheduled PSG recording | -Feasibility of the procedures will be assessed by descriptive analysis | Through completion of study (approximately 50 days) | 
| Effect of bright light on fatigue as measured by PROMIS-Cancer Fatigue |  | Through completion of study (approximately 50 days) | 
| Effect of bright light on fatigue as measured by VAS (diurnal fatigue) in Daily Fatigue and Sleep Log |  | Through of completion of study (approximately 43 days) | 
| Effect of bright light on sleep patterns as measured by PSG |  | Through completion of study (approximately 50 days) | 
| Effect of bright light on sleep patterns as measured by PROMIS-Sleep Disturbance |  | Through of completion of study (approximately 43 days) | 
| Effect of bight light on sleep patterns as measured by PSQI |  | Through completion of study (approximately 50 days) | 
| Effect of bright light on wake patterns as measured by PSG |  | Through completion of study (approximately 50 days) | 
| Effect of bright light on wake patterns as measured by ESS |  | Through completion of study (approximately 50 days) | 
| Effect of bright light on wake patterns as measured by VAS (daytime sleepiness) in Daily Fatigue and Sleep Log |  | Through completion of study (approximately 50 days) | 
| Effect of bright light on quality of life as measured by EORCT QLQ C-30 |  | Through completion of study (approximately 50 days) | 
| Feasibility of implementing a bright light intervention as measured by completion rates of self-report forms | -Feasibility of the procedures will be assessed by descriptive analysis | Through completion of study (approximately 50 days) |