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

Not Applicable

Completed

Conditions: Breast Cancer

Registration Number: NCT03304587

Lead Sponsor: Michigan State University

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.

Detailed 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 & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 30

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Study Attrition and Adherence	Up to 3 weeks from registration	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

Secondary Outcome Measures

Name	Time	Method
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)	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.
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)	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.
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)	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.
Effects of Bright Light on Fatigue as Measured by the Daily Log	Kept throughout the approx 3 weeks of the study	Fatigue self-report is rated numerically from 1-5, with greater score meaning more fatigue
Effect of Bright Light on Quality of Life as Measured by EORTC QLQ-30	Baseline (day 2 of study) and Post-treatment (approx day 17 of study)	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
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)	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.
Effects of Bright Light on Depression as Measured by the CES-D	Baseline (day 2 of study) and Post-treatment (approx day 17 of study)	Center for Epidemiologic Studies Depression Scale (CES-D) score: Total CES-D range is 0-60, with higher score meaning more depressed.
Effects of Bright Lights on Cognitive Dysfunction as Measured by the MoCA	Baseline (day 2 of study) and Post-treatment (approx day 17 of study)	MoCA (Montreal Cognitive Assessment): Test conducted by researcher, with total score range 0-30. Higher score means less cognitive dysfunction.
Effect of Bright Light on Quality of Life as Measured by the PROMIS-Physical Function	Baseline (day 2 of study) and Post-treatment (approx day 17 of study)	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.
Effects of Bright Light on Level of Stress as Measured by the PSG-Total Sleep Time	Baseline (day 2 of study) and Post-treatment (approx day 17 of study)	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.
Effects of Bright Light on Level of Stress as Measured by the PSG-Sleep Onset Latency	Baseline (day 2 of study) and Post-treatment (approx day 17 of study)	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.
Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (Min)	Baseline (day 2 of study) and Post-treatment (approx day 17 of study)	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.
Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (%)	Baseline (day 2 of study) and Post-treatment (approx day 17 of study)	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.
Effects of Bright Light on Level of Stress as Measured by the PSG-Sleep Efficiency	Baseline (day 2 of study) and Post-treatment (approx day 17 of study)	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.
Effects of Bright Light on Level of Stress as Measured by the PSG-Awakenings	Baseline (day 2 of study) and Post-treatment (approx day 17 of study)	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.
Effects of Bright Light on Level of Stress as Measured by the PSG-Arousals	Baseline (day 2 of study) and Post-treatment (approx day 17 of study)	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
Effects of Bright Light on Level of Stress as Measured by the PSG-Arousal Index	Baseline (day 2 of study) and Post-treatment (approx day 17 of study)	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.
Effects of Bright Light on Level of Stress as Measured by the PSG-Wake After Sleep Onset (WASO)	Baseline (day 2 of study) and Post-treatment (approx day 17 of study)	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.

Trial Locations

Locations (1): Michigan State University
🇺🇸
East Lansing, Michigan, United States
Michigan State University
🇺🇸East Lansing, Michigan, United States