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

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• Breast Neoplasms 12,520

Study arms

• Experimental
  Arm 1: Bright blue-green light

  * 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

• Active comparator
  Arm 2: Dim red light

  * 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

• Diagnostic testPolysomnography (PSG)

  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

• Diagnostic testRectal thermistor 400 Series

  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.

• OtherBright blue-green light

  -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

• OtherDim red light

  -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

• Diagnostic testDigital foot candle datalogging light meter

  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.

• OtherPatient-Reported Outcomes Measurement Information System (PROMIS)-Cancer-Fatigue

  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

• OtherPatient-Reported Outcomes Measurement Information System (PROMIS)-Sleep Disturbance

  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

• OtherPatient-Reported Outcomes Measurement Information System (PROMIS)-Depression

  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

• OtherPatient-Reported Outcomes Measurement Information System (PROMIS)-Physical Function

  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

• OtherPittsburgh Sleep Quality Index (PSQI)

  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

• OtherCenter for Epidemiological Studies - Depression

  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

• OtherMontreal Cognitive Assessment (MoCA)

  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

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

  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

• OtherDaily Log

  -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

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

   Time frame: Up to 3 weeks from registration

Secondary outcomes

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

   Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep disturbance T-Score. A higher PROMIS-Sleep disturbance T-score represents greater\\worse sleep disturbance. 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 mean worse sleep disturbance Note: For negatively-worded concepts like Fatigue, a T-score of 60 is one SD worse than average. By comparison, a Fatigue T-score of 40 is one SD better than average.

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

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

   Pittsburgh Sleep Quality Index (PSQI) Global score: The PSQI has 7 components, with each component self-rated from 0-3, with 3 being worse sleep quality. Global PSQI sleep score is the sum of all 7 components, with score range from 0-21, with higher score meaning worse sleep quality.

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

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

   Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer-Fatigue T-Score. A higher PROMIS-Cancer-Fatigue T-score represents greater\\worse fatigue. 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 mean worse fatigue Note: For negatively-worded concepts like Fatigue, a T-score of 60 is one SD worse than average. By comparison, a Fatigue T-score of 40 is one SD better than average.

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

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

   Fatigue self-report is rated numerically from 1-5, with greater score meaning more fatigue

   Time frame: Kept throughout the approx 3 weeks of the study

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

   Patient-Reported Outcomes Measurement Information System (PROMIS)-Depression T-Score. A higher PROMIS-Depression T-score represents greater\\worse Depression. 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 mean worse worse depression. Note: For negatively-worded concepts like Fatigue, a T-score of 60 is one SD worse than average. By comparison, a Fatigue T-score of 40 is one SD better than average.

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

6. Effects of Bright Light on Depression as Measured by the CES-D

   Center for Epidemiologic Studies Depression Scale (CES-D) score: Total CES-D range is 0-60, with higher score meaning more depressed.

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

7. Effects of Bright Lights on Cognitive Dysfunction as Measured by the MoCA

   MoCA (Montreal Cognitive Assessment): Test conducted by researcher, with total score range 0-30. Higher score means less cognitive dysfunction.

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

8. Effect of Bright Light on Quality of Life as Measured by the PROMIS-Physical Function

   Patient-Reported Outcomes Measurement Information System (PROMIS)-Physical Function T-Score. A higher PROMIS-Physical Function T-score represents greater\\better 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 mean better functioning. Note: A T-score of 60 is one SD greater than average; A T-Score of 40 is one SD lower than average.

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

9. Effect of Bright Light on Quality of Life as Measured by EORTC QLQ-30

   Quality of Life (QOL)-Global Health score: Range 0-100, higher score is better global health quality of life Quality of Life (QOL) Symptom score: Range 0-100, Higher score is worse symptoms quality of life Quality of Life (QOL)-Function: Range 0-100, Higher score is better functional quality of life

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

10. Effects of Bright Light on Level of Stress as Measured by the PSG-Total Sleep Time

    Objective testing using in-lab polysomnography (PSG) is used to measure the effects of bright light on level of stress. Minutes of total sleep time is reported.

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

11. Effects of Bright Light on Level of Stress as Measured by the PSG-Sleep Efficiency

    Objective testing using in-lab polysomnography (PSG)is used to measure the effects of bright light on level of stress. Sleep efficiency is reported as percentage of total sleep time.

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

12. Effects of Bright Light on Level of Stress as Measured by the PSG-Sleep Onset Latency

    Objective testing using in-lab polysomnography (PSG) is used to measure the effects of bright light on level of stress. Minutes of latency to sleep onset is reported.

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

13. Effects of Bright Light on Level of Stress as Measured by the PSG-Awakenings

    Objective testing using in-lab polysomnography (PSG)is used to measure the effects of bright light on level of stress. Minutes of awakenings during sleep is recorded.

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

14. Effects of Bright Light on Level of Stress as Measured by the PSG-Arousals

    Objective testing using in-lab polysomnography (PSG)is used to measure the effects of bright light on level of stress. Arousal minutes during sleep are recorded

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

15. Effects of Bright Light on Level of Stress as Measured by the PSG-Arousal Index

    Objective testing using in-lab polysomnography (PSG) is used to measure the effects of bright light on level of stress. Arousal index is total number of arousals per hour of sleep.

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

16. Effects of Bright Light on Level of Stress as Measured by the PSG-Wake After Sleep Onset (WASO)

    Objective testing using in-lab polysomnography (PSG) is used to measure the effects of bright light on level of stress. Minutes till wake after sleep onset is reported.

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

17. Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (Min)

    Objective testing using in-lab polysomnography (PSG) used to measure effects of bright light on level of stress. Minutes spent in each sleep stage is reported. Stage 1 is when a person first falls asleep, normally lasts 1-7minutes. Body has not fully relaxed, though body and brain activities start to slow with periods of brief movements. Stage 2 the body enters a more subdued state including a drop in temperature, relaxed muscles and slowed breathing and heart rate. Stage 3 muscle tone, pulse and breathing rate decrease as body relaxes. REM brain activity picks up, body experiences atonia-a temporary paralysis of muscles except for eyes and muscles that control breathing. Usually takes 90 minutes to reach REM stage.

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

18. Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (%)

    Objective testing using in-lab polysomnography (PSG) is used to measure the effects of bright light on level of stress. Percentage of time in each sleep stage is reported. Stage 1 is when a person first falls asleep, normally lasts 1-7minutes. Body has not fully relaxed, though body and brain activities start to slow with periods of brief movements. Stage 2 the body enters a more subdued state including a drop in temperature, relaxed muscles and slowed breathing and heart rate. Stage 3 muscle tone, pulse and breathing rate decrease as body relaxes. REM brain activity picks up, body experiences atonia-a temporary paralysis of muscles except for eyes and muscles that control breathing. Usually takes 90 minutes to reach REM stage.

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

Baseline characteristics

5 further baseline measures are reported on the registry.

Related links

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

Study documents

• Study protocol · May 1, 2022
• Statistical analysis plan · May 1, 2022
• Informed consent form · May 23, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No