Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Bright Light on Fatigue in Women Being Treated for Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02658708
Recruitment Status : Completed
First Posted : January 20, 2016
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE January 6, 2016
First Posted Date  ICMJE January 20, 2016
Last Update Posted Date September 25, 2017
Actual Study Start Date  ICMJE October 12, 2015
Actual Primary Completion Date May 9, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 14, 2016)
  • Feasibility of implementing a bright light intervention as measured by estimating completion of scheduled PSG recording [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Through of completion of study (approximately 43 days) ]
  • Effect of bright light on sleep patterns as measured by PSG [ Time Frame: Through completion of study (approximately 50 days) ]
  • Effect of bright light on sleep patterns as measured by PROMIS-Sleep Disturbance [ Time Frame: Through of completion of study (approximately 43 days) ]
  • Effect of bight light on sleep patterns as measured by PSQI [ Time Frame: Through completion of study (approximately 50 days) ]
  • Effect of bright light on wake patterns as measured by PSG [ Time Frame: Through completion of study (approximately 50 days) ]
  • Effect of bright light on wake patterns as measured by ESS [ Time Frame: 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 [ Time Frame: Through completion of study (approximately 50 days) ]
  • Effect of bright light on quality of life as measured by EORCT QLQ C-30 [ Time Frame: Through completion of study (approximately 50 days) ]
  • Feasibility of implementing a bright light intervention as measured by completion rates of self-report forms [ Time Frame: Through completion of study (approximately 50 days) ]
    -Feasibility of the procedures will be assessed by descriptive analysis
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bright Light on Fatigue in Women Being Treated for Breast Cancer
Official Title  ICMJE Bright Light on Fatigue in Women Being Treated for Breast Cancer: A Pilot Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Neoplasms
  • Breast Cancer
  • Cancer of Breast
  • Cancer of the Breast
Intervention  ICMJE
  • 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 Name: EORCT QLQ C-30
  • 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 Name: ESS
  • 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 Name: PSQI
  • 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 Name: PSG
  • Other: Horne-Ostberg Morningness-Eveningness Questionnaire
    Other Name: MEQ
  • 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)
Study Arms  ICMJE
  • Experimental: Arm 1: Bright blue-green light
    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
    Interventions:
    • Other: Bright blue-green 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
  • Active Comparator: Arm 2: Dim red light
    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
    Interventions:
    • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 22, 2017)
19
Original Estimated Enrollment  ICMJE
 (submitted: January 14, 2016)
80
Actual Study Completion Date  ICMJE May 9, 2017
Actual Primary Completion Date May 9, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02658708
Other Study ID Numbers  ICMJE 201503075
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Horng-Shiuann Wu, Ph.D., R.N. Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP