Bright Light on Fatigue in Women Being Treated for Breast Cancer

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

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)

Sponsors & Collaborators

• Washington University School of Medicine

  lead OTHER

Principal Investigators

• Horng-Shiuann Wu, Ph.D., R.N. · Washington University School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-10-12

Primary Completion

2017-05-09

Completion

2017-05-09

Countries

• United States

Study Locations