Effects of Bright Light on Co-occurring Cancer-related Symptoms in Breast Cancer Survivors

NCT03304587 | Completed Results DMC FDA Device

• 2 other identifiers: 2017031471R15NR016828-01A1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study will implement therapeutic bright light that is tailored to the individual's circadian typology and will estimate its effects on circadian rhythms, 4 common cancer-associated symptoms, and impact on quality of life in survivors living with cancer. Examining a selected phase marker (core body temperature) in relation to the associated clinical features (symptoms) is the starting point for future investigation of the biological mechanisms of symptoms.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Study Attrition and Adherence

  Study participants kept a daily log where they listed the dates and times they used the light visor - noting time they put it on, and the time they took it off. The light exposure were recorded to assess adherence to the treatment protocol. Adherence: percentage that the study participant used the light visor for 30 minutes per day during the 14-day light therapy intervention (based on the daily log that reported use or not use of the light visor for 30 minutes for the 14 days of the intervention and the time they put it on each day and took it off each day) Attrition: study participants withdrew from the study prior to completing the intervention

  Up to 3 weeks from registration

Secondary Outcomes (18)

• Effects of Bright Light on Sleep Disturbance as Measured by the PROMIS-Sleep Disturbance

  Baseline (day 2 of study) and Post-treatment (approx day 17 of study)

• Effects of Bright Light on Sleep Disturbance as Measured by the PSQI

  Baseline (day 2 of study) and Post-treatment (approx day 17 of study)

• Effects of Bright Light on Fatigue as Measured by the PROMIS-Cancer-Fatigue

  Baseline (day 2 of study) and Post-treatment (approx day 17 of study)

• Effects of Bright Light on Fatigue as Measured by the Daily Log

  Kept throughout the approx 3 weeks of the study

• Effects of Bright Light on Depression as Measured by the PROMIS-Depression

  Baseline (day 2 of study) and Post-treatment (approx day 17 of study)

Study Arms (2)

Arm 1: Bright blue-green light

EXPERIMENTAL

* Bright blue-green light (\~515nm; 12,000 lux) for 30 minutes once a day. * For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings. * Light therapy will be self-administered using a light visor cap * Each participant will make (3) overnight visits to the sleep laboratory * On 2 randomly selected days, the participants will wear a light meter during wake time

Diagnostic Test: Polysomnography (PSG); Diagnostic Test: Rectal thermistor 400 Series; Other: Bright blue-green light; Diagnostic Test: Digital foot candle datalogging light meter; Other: Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer-Fatigue; Other: Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep Disturbance; Other: Patient-Reported Outcomes Measurement Information System (PROMIS)-Depression; Other: Patient-Reported Outcomes Measurement Information System (PROMIS)-Physical Function; Other: Pittsburgh Sleep Quality Index (PSQI); Other: Center for Epidemiological Studies - Depression; Other: Montreal Cognitive Assessment (MoCA); Other: European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire (EORTC QLQ-C30); Other: Daily Log

Arm 2: Dim red light

ACTIVE COMPARATOR

* Dim red light (5 lux) (control group) for 30 minutes once a day. --For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings. * Light therapy will be self-administered using a light visor cap * Each participant will make (3) overnight visits to the sleep laboratory --On 2 randomly selected days, the participants will wear a light meter during wake time

Diagnostic Test: Polysomnography (PSG); Diagnostic Test: Rectal thermistor 400 Series; Other: Dim red light; Diagnostic Test: Digital foot candle datalogging light meter; Other: Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer-Fatigue; Other: Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep Disturbance; Other: Patient-Reported Outcomes Measurement Information System (PROMIS)-Depression; Other: Patient-Reported Outcomes Measurement Information System (PROMIS)-Physical Function; Other: Pittsburgh Sleep Quality Index (PSQI); Other: Center for Epidemiological Studies - Depression; Other: Montreal Cognitive Assessment (MoCA); Other: European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire (EORTC QLQ-C30); Other: Daily Log

Interventions

Polysomnography (PSG) DIAGNOSTIC_TEST

Sleep patterns will be measured by in-lab PSG following a standardized protocol. 10mm silver/silver chloride electroencephalogram (EEG) and electromyography (EMG) electrodes and 11mm silver/silver chloride electroculography (EOG) electrodes will be connected to a Nihon Kohden system, 912 model (Nihon Kohden, Irvine, CA). A standard sleep montage following the 10/20 procedure for electrode placement, left and right electrooculography referenced to the opposite mastoid and mentalis electromyography will be followed. Data will be visually scored by a polysomnographer blind to study conditions following the American Academy of Sleep Medicine (AASM) Manual.

Also known as: PSG

Arm 1: Bright blue-green light; Arm 2: Dim red light

Rectal thermistor 400 Series DIAGNOSTIC_TEST

Nocturnal core body temperature will be measured using a rectal thermistor 400 series manufactured by YSI (Yellow Springs, OH, USA) inserted up to a depth of 7 cm. and taped in place. The thermistor will be connected to a Model 4600 thermometer (YSI, Yellow Springs, OH, USA) that will be interfaced with the PSG via cabling. Core temperature readings will be continuously monitored and recorded every 5 minutes during the all-night sleep studies.

Arm 1: Bright blue-green light; Arm 2: Dim red light

Bright blue-green light OTHER

-The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect

Arm 1: Bright blue-green light

Dim red light OTHER

-The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect

Arm 2: Dim red light

Digital foot candle datalogging light meter DIAGNOSTIC_TEST

On 2 random days during the 2-week bright light treatment, ambient light will be recorded continuously during waking hours using a digital foot candle datalogging light meter (Extech Instruments, Waltham, MA) Model SDL400. The 7.1" x 2.9" x 1.0" light meter (12.21 oz) has the capacity to measure up to 10,000 footcandles (accuracy: ± 4% reading). 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.

Arm 1: Bright blue-green light; Arm 2: Dim red light

Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer-Fatigue OTHER

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. PROMIS-Fatigue was developed based on rigorous methodologies. The psychometric properties have been established across chronic illnesses including cancer. PROMIS measures provide a common metric: the T-score (mean = 50, standard deviation = 10). A mean of 50 equals the mean in the U.S. general population. Higher scores means more the attribute to be measures: e.g., for fatigue, sleep disturbance, depression, higher scores mean worse fatigue, worse sleep disturbance, worse depression. But for physical function, higher scores mean better functioning.

Also known as: PROMIS-Cancer-Fatigue

Arm 1: Bright blue-green light; Arm 2: Dim red light

Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep Disturbance OTHER

8 items with 5-point rating scales measuring overall sleep and sleep-related impairments. Higher scores indicate worse sleep disturbances. Validity was supported by moderate to high correlations with the existing scales, e.g. PSQI, Epworth Sleepiness Scale (ESS). The scores significantly differed participants with and without sleep disorders. PROMIS measures provide a common metric: the T-score (mean = 50, standard deviation = 10). A mean of 50 equals the mean in the U.S. general population. Higher scores means more the attribute to be measures: e.g., for fatigue, sleep disturbance, depression, higher scores mean worse fatigue, worse sleep disturbance, worse depression. But for physical function, higher scores mean better functioning.

Also known as: PROMIS-Sleep Disturbance

Arm 1: Bright blue-green light; Arm 2: Dim red light

Patient-Reported Outcomes Measurement Information System (PROMIS)-Depression OTHER

8 items with 5-point rating scales (1=never to 5=always) measuring affective and cognitive manifestations of depressive mood. Higher scores indicate worse depression. In a sample of depressed outpatients, PROMIS-Depression showed greater reliability when compared to the CES-D and the Patient Health Questionnaire (PHQ-9). Convergent validity with the CES-D and PHQ-9 was supported by strong correlations, ranged 0.72 to 0.84 PROMIS measures provide a common metric: the T-score (mean = 50, standard deviation = 10). A mean of 50 equals the mean in the U.S. general population. Higher scores means more the attribute to be measures: e.g., for fatigue, sleep disturbance, depression, higher scores mean worse fatigue, worse sleep disturbance, worse depression. But for physical function, higher scores mean better functioning.

Also known as: PROMIS-Depression

Arm 1: Bright blue-green light; Arm 2: Dim red light

Patient-Reported Outcomes Measurement Information System (PROMIS)-Physical Function OTHER

8 items with 5-point rating scales measuring the individual's ability to complete daily activities. Higher scores indicate worse functioning. Validity was tested in 1,415 adults with diverse clinical conditions. The PROMIS Physical Function scores corresponded to the expected positive or negative changes in the individual's physical function. PROMIS measures provide a common metric: the T-score (mean = 50, standard deviation = 10). A mean of 50 equals the mean in the U.S. general population. Higher scores means more the attribute to be measures: e.g., for fatigue, sleep disturbance, depression, higher scores mean worse fatigue, worse sleep disturbance, worse depression. But for physical function, higher scores mean better functioning.

Also known as: PROMIS-Physical Function

Arm 1: Bright blue-green light; Arm 2: Dim red light

Pittsburgh Sleep Quality Index (PSQI) OTHER

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. A global PSQI score greater than 5 was found to have a sensitivity of 89.6% and a specificity of 86.5% in differentiating good and poor sleepers.

Also known as: PSQI

Arm 1: Bright blue-green light; Arm 2: Dim red light

Center for Epidemiological Studies - Depression OTHER

20-item self-report instrument commonly used to measure depressive symptoms in cancer patients. Each item is rated on a 4-point rating scale (0=rarely or none of the time to 3=all of the time) describing the frequency of occurrence during the past week. Score can range from 0-60, with higher scores indicating more depressive symptoms.

Also known as: CES-D

Arm 1: Bright blue-green light; Arm 2: Dim red light

Montreal Cognitive Assessment (MoCA) OTHER

The MoCA is highly sensitive for screening patient with mild cognitive impairment. The MoCA is a 30-point scale with 7 cognitive subtests: visuo-executive, naming, attention, language, abstraction, delayed recall, and orientation. It scores from 0 to 30, where higher scores indicate better cognition and a score below 26 indicates cognitive impairment. The MoCA is highly sensitive for screening patient with mild cognitive impairment.

Also known as: MoCA

Arm 1: Bright blue-green light; Arm 2: Dim red light

European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire (EORTC QLQ-C30) OTHER

The EORTC QLQ-C30 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 during the past week.

Also known as: EORTC QLQ-C30

Arm 1: Bright blue-green light; Arm 2: Dim red light

Daily Log OTHER

-A log where the participants will indicate date, wake time, sleep time answer 3 questions regarding the previous nights sleep (answers range from 1=not at all to 5=very much), have an area to indicate if naps occurred during the day, and 2 questions about fatigue \& sleepiness (answers ranging from 0=no fatigue/sleepiness to 10=worst fatigue/sleepiness

Arm 1: Bright blue-green light; Arm 2: Dim red light

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females
• years of age or older 1-3 years post-completion of chemotherapy or/and radiation therapy for stage I-III breast cancer
• Experience ≥ 2 concurrent symptoms (fatigue, sleep disruption, depressive symptoms, and/or cognitive dysfunction as measured by 4 screening instruments)
• Be either phase advanced or delayed (morning or evening types by the Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ) ≥59 or ≤41)
• Sighted
• Mentally competent to consent
• Able to understand English.

You may not qualify if:

• Undergoing cancer treatment for another malignancy
• Have metastatic cancer
• Engaged in shift work or travel across more than three time zones within 2 weeks prior to study
• Current diagnosis of seasonal affective disorder or substance abuse Current diagnosis of major Axis I psychiatric disorders (e.g. depressive disorders), neurological impairments, or muscular dystrophies
• Report severe depressive mood (Center for Epidemiological Studies Depression Scale (CES-D) \>24)
• Take prescribed sedative hypnotics or steroids 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)

Sponsors & Collaborators

• Michigan State University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Michigan State University

East Lansing, Michigan, 48824, United States

Location

Related Publications (2)

• Wu HS, Gao F, Davis JE, Given CW. Effects of chronotype-tailored bright light intervention on post-treatment symptoms and quality of life in breast cancer survivors. Support Care Cancer. 2023 Nov 17;31(12):705. doi: 10.1007/s00520-023-08157-9.

  PMID: 37975923 DERIVED

• Wu HS, Gao F, Davis JE, Given CW. Effects of Chronotype-tailored Bright Light Intervention on Symptoms and Quality of Life in Breast Cancer Survivors. Res Sq [Preprint]. 2023 Aug 25:rs.3.rs-3286350. doi: 10.21203/rs.3.rs-3286350/v1.

  PMID: 37674711 DERIVED

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Polysomnography; Multicenter Studies as Topic; Mental Status and Dementia Tests

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Dr. Horng-Shiuann Wu, Associate Professor
• Organization: Michigan State University College of Nursing

wuhorngs@msu.edu

517-884-4643

Study Officials

• Horng-Shiuann Wu, PhD

  Michigan State University College of Nursing

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 3, 2017
• First Posted: October 9, 2017
• Study Start: November 6, 2017
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: June 10, 2025
• Results First Posted: June 10, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)