Breast Neoplasms, Breast Cancer, Cancer of Breast, Cancer of the Breast
Conditions
Brief 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.
Interventions
OTHERBright blue-green light using light visor cap
OTHERDim red light using light visor cap
OTHEREuropean 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
-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
-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
-Consists of 8 items with 5-point rating scales measuring overall sleep and sleep-related impairments. Higher scores indicate worse sleep disturbances
-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_TESTDigital 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_TESTPolysomnography (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
OTHERHorne-Ostberg Morningness-Eveningness Questionnaire
OTHERDaily 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)
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of implementing a bright light intervention as measured by estimating completion of scheduled PSG recording | Through completion of study (approximately 50 days) | -Feasibility of the procedures will be assessed by descriptive analysis |
| 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 | Through completion of study (approximately 50 days) | -Feasibility of the procedures will be assessed by descriptive analysis |
Countries
United States
Outcome results
None listed