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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03304587
• Other study ID #: 201703147
• Secondary ID: 1R15NR016828-01A
• Status: Completed
• Phase: N/A
• Start date: November 6, 2017
• Est. completion date: August 31, 2022

Study information

• Verified date: September 2022
• Source: Michigan State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The purpose of this pilot study is to evaluate the feasibility of implementing a home-based, personalized bright light intervention, and to estimate the effects of bright light on 4 common long-term or late effects of cancer (sleep disturbance, fatigue, depression, cognitive dysfunction) and on quality of life in post-treatment survivors of breast cancer. The three specific aims include: Aim #1: To assess the feasibility of implementing a home-based, personalized bright light intervention and the proposed data collection plan in post-treatment survivors of breast cancer. Aim #2: To estimate the effects of the personalized bright light intervention on sleep disturbance, fatigue, depression, cognitive dysfunction, and quality of life in survivors of breast cancer. Aim #3: To estimate the effects of a personalized bright light intervention on circadian rhythms in survivors of breast cancer. The participants of this randomized, controlled pilot study will be randomized to either 30-minute blue-green light therapy at 12,000 lux or dim red light control at 5 lux. Light will be self-administered using a light visor cap at home for 14 consecutive days. Tailored to the individual's circadian pattern, light will be delivered either within 30 minutes of waking in the morning or between 1900-2000 hours in the evening. The nocturnal sleep patterns will be monitored by all-night in-lab polysomnography; sleep quality, fatigue, depression, and quality of life will be self-reported; cognition will be objectively assessed before and after the intervention. Circadian rhythm will be indexed by nocturnal core body temperature before and after the intervention. Feasibility will be determined by the proportion of contacted, recruited, and retained subjects, and completeness of the data collected. Subjective feedback and burden will be assessed at study exit.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Females
• 21 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.

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Diagnostic Test:
• Polysomnography (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 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.

Other:
• Bright 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
• Dim 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 Test:
• Digital 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.

Other:
• Patient-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.
• Patient-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.
• Patient-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
• Patient-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.
• Pittsburgh 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.
• Center 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.
• Montreal 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.
• European 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.
• Daily 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

Locations

Country	Name	City	State
United States	Michigan State University	East Lansing	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Michigan State University	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of implementing a home-based, personalized bright light intervention	-The on and off times of each light exposure will be recorded to assess adherence to the treatment protocol	Up to 3 weeks from registration
Secondary	Effects of bright light on sleep disturbance as measured by the PROMIS-Sleep Disturbance		Up to 3 weeks from registration
Secondary	Effects of bright light on sleep disturbance as measured by the PSQI		Up to 3 weeks from registration
Secondary	Effects of bright light on fatigue as measured by the PROMIS-Cancer-Fatigue		Up to 3 weeks from registration
Secondary	Effects of bright light on fatigue as measured by the Daily Log		Up to 3 weeks from registration
Secondary	Effects of bright light on depression as measured by the PROMIS-Depression		Up to 3 weeks from registration
Secondary	Effects of bright light on depression as measured by the CES-D		Up to 3 weeks from registration
Secondary	Effects of bright lights on cognitive dysfunction as measured by the NIH Toolbox Cognition Battery		Up to 3 weeks from registration
Secondary	Effects of bright lights on cognitive dysfunction as measured by the MoCA		Up to 3 weeks from registration
Secondary	Effect of bright light on quality of life as measured by the PROMIS-Physical Function		Up to 3 weeks from registration
Secondary	Effect of bright light on quality of life as measured by EORTC QLQ-30		Up to 3 weeks from registration
Secondary	Effect of bright light on circadian rhythms as measured by core body temperature		Up to 3 weeks from registration
Secondary	Effects of bright light on level of stress as measured by the PSG		Up to 3 weeks from registration
Secondary	Effects of bright light on ambient light exposure as measured by length of exposure x luminous intensity		Up to 3 weeks from registration

External Links

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