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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Bright blue-green light | Experimental | 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 |
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| Arm 2: Dim red light | Active Comparator | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bright blue-green light using light visor cap | Other |
| ||
| Dim red light using light visor cap |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Horng-Shiuann Wu, Ph.D., R.N. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33478260 | Derived | 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. |
| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| Other |
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| European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire | Other | -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 |
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| Epworth Sleepiness Scale | Other | -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 |
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| Pittsburgh Sleep Quality Index | Other | -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 |
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| Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep Disturbance | Other | -Consists of 8 items with 5-point rating scales measuring overall sleep and sleep-related impairments. Higher scores indicate worse sleep disturbances |
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| Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer-Fatigue | Other | -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. |
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| Digital foot candle datalogging light meter (Extech Instrument, Model SDL400) | Diagnostic Test | -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. |
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| Polysomnography (Easy Ambulatory 2 Cadwell, Kennewick, WA) | Diagnostic Test | -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 |
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| Horne-Ostberg Morningness-Eveningness Questionnaire | Other |
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| Daily Fatigue and Sleep Log | Other |
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| 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) |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D017286 | Polysomnography |
| ID | Term |
|---|---|
| D008991 | Monitoring, Physiologic |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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