Bright Light on Fatigue in Women Being Treated for Breast Cancer

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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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Breast Neoplasms Breast Cancer Cancer of Breast Cancer of the Breast	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 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	Phase 1

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	19 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Bright Light on Fatigue in Women Being Treated for Breast Cancer: A Pilot Study
Actual Study Start Date :	October 12, 2015
Actual Primary Completion Date :	May 9, 2017
Actual Study Completion Date :	May 9, 2017

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Breast cancer

MedlinePlus related topics: Breast Cancer Fatigue

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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	Other: Bright blue-green 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)
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	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)

Arm

Intervention/treatment

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

Other: Bright blue-green 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)

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

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

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)

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)

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	21 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02658708

Locations

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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110

Sponsors and Collaborators

Washington University School of Medicine

Investigators

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Principal Investigator:	Horng-Shiuann Wu, Ph.D., R.N.	Washington University School of Medicine

More Information

Additional Information:

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

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Responsible Party:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT02658708
Other Study ID Numbers:	201503075
First Posted:	January 20, 2016 Key Record Dates
Last Update Posted:	September 25, 2017
Last Verified:	September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Breast Neoplasms Fatigue Neoplasms by Site	Neoplasms Breast Diseases Skin Diseases

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