NCT02658708

Bright Light on Fatigue in Women Being Treated for Breast Cancer

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Breast Neoplasms
• Breast Cancer
• Cancer of Breast
• Cancer of the Breast

Interventions

Type	Name	Description
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	-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
OTHER	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
OTHER	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
OTHER	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
OTHER	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.
DIAGNOSTIC_TEST	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.
DIAGNOSTIC_TEST	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
OTHER	Horne-Ostberg Morningness-Eveningness Questionnaire
OTHER	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)

Timeline

• Start date: 2015-10-12
• Primary completion: 2017-05-09
• Completion: 2017-05-09
• First posted: 2016-01-20
• Last updated: 2017-09-25

Locations

1 site across 1 country: United States