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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 21 years and older
• Women only
• Healthy volunteers accepted
• Adult, Older adult

Trial locations and contacts

1 site in 1 country.

About this study

Official title: Effects of Bright Light on Co-occurring Cancer-related Symptoms in Breast Cancer Survivors: A Personalized Intervention

Conditions

Breast Cancer

Being tested

Polysomnography (PSG), Rectal thermistor 400 Series, Bright blue-green light, Dim red light, Digital foot candle datalogging light meter

Medical subject headings

Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Polysomnography (PSG)Diagnostic test

  Also called 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.

• Rectal thermistor 400 SeriesDiagnostic 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.

• Bright blue-green lightOther

  -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

• Dim red lightOther

  -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

• Digital foot candle datalogging light meterDiagnostic 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.

• Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer-FatigueOther

  Also called 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.

• Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep DisturbanceOther

  Also called 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.

• Patient-Reported Outcomes Measurement Information System (PROMIS)-DepressionOther

  Also called 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.

• Patient-Reported Outcomes Measurement Information System (PROMIS)-Physical FunctionOther

  Also called 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.

• Pittsburgh Sleep Quality Index (PSQI)Other

  Also called 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.

• Center for Epidemiological Studies - DepressionOther

  Also called CES-D

  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.

• Montreal Cognitive Assessment (MoCA)Other

  Also called 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.

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

  Also called 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.

• Daily LogOther

  -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

What is being measured

The primary outcome is the main question the study is designed to answer.

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

   Measured: Up to 3 weeks from registration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted9 Oct 2017
2. Study start6 Nov 2017
3. Primary completion31 Aug 2022
4. Study completion31 Aug 2022

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Publications (2)Papers the sponsor has linked to this study.
• Other trials for Breast CancerStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.