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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Diagnostic Test: Polysomnography (PSG); Diagnostic Test: Rectal thermistor 400 Series; Other: Bright blue-green light; 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

• 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.

Study Timeline

• Study First Submitted: 2017-10-03
• Study First Submitted QC: 2017-10-03
• Study First Posted: 2017-10-09
• Study Start: 2017-11-06
• Primary Completion: 2022-08-31
• Study Completion: 2022-08-31
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-08
• Last Update Posted: 2022-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 95

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

Arm && Interventions

Group	Intervention	Description
Arm 1: Bright blue-green light	Rectal thermistor 400 Series	* 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
Arm 1: Bright blue-green light	Polysomnography (PSG)	* 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
Arm 1: Bright blue-green light	Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer-Fatigue	* 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
Arm 1: Bright blue-green light	Center for Epidemiological Studies - Depression	* 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
Arm 2: Dim red light	Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer-Fatigue	* 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
Arm 2: Dim red light	Rectal thermistor 400 Series	* 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
Arm 1: Bright blue-green light	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
Arm 1: Bright blue-green light	Digital foot candle datalogging light meter	* 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
Arm 1: Bright blue-green light	European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire (EORTC QLQ-C30)	* 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
Arm 1: Bright blue-green light	Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep Disturbance	* 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
Arm 1: Bright blue-green light	Patient-Reported Outcomes Measurement Information System (PROMIS)-Depression	* 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
Arm 1: Bright blue-green light	Pittsburgh Sleep Quality Index (PSQI)	* 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
Arm 1: Bright blue-green light	Daily Log	* 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
Arm 1: Bright blue-green light	Patient-Reported Outcomes Measurement Information System (PROMIS)-Physical Function	* 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
Arm 1: Bright blue-green light	Montreal Cognitive Assessment (MoCA)	* 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
Arm 2: Dim red light	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
Arm 2: Dim red light	Patient-Reported Outcomes Measurement Information System (PROMIS)-Depression	* 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
Arm 2: Dim red light	Pittsburgh Sleep Quality Index (PSQI)	* 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
Arm 2: Dim red light	Polysomnography (PSG)	* 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
Arm 2: Dim red light	Patient-Reported Outcomes Measurement Information System (PROMIS)-Physical Function	* 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
Arm 2: Dim red light	Digital foot candle datalogging light meter	* 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
Arm 2: Dim red light	Daily Log	* 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
Arm 2: Dim red light	Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep Disturbance	* 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
Arm 2: Dim red light	Center for Epidemiological Studies - Depression	* 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
Arm 2: Dim red light	Montreal Cognitive Assessment (MoCA)	* 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
Arm 2: Dim red light	European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire (EORTC QLQ-C30)	* 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

Primary Outcome Measures

Name	Time	Method
Feasibility of implementing a home-based, personalized bright light intervention	Up to 3 weeks from registration	-The on and off times of each light exposure will be recorded to assess adherence to the treatment protocol

Secondary Outcome Measures

Name	Time	Method
Effects of bright light on fatigue as measured by the Daily Log	Up to 3 weeks from registration
Effects of bright light on depression as measured by the CES-D	Up to 3 weeks from registration
Effects of bright lights on cognitive dysfunction as measured by the NIH Toolbox Cognition Battery	Up to 3 weeks from registration
Effect of bright light on quality of life as measured by EORTC QLQ-30	Up to 3 weeks from registration
Effects of bright light on level of stress as measured by the PSG	Up to 3 weeks from registration
Effects of bright light on sleep disturbance as measured by the PROMIS-Sleep Disturbance	Up to 3 weeks from registration
Effects of bright light on fatigue as measured by the PROMIS-Cancer-Fatigue	Up to 3 weeks from registration
Effect of bright light on quality of life as measured by the PROMIS-Physical Function	Up to 3 weeks from registration
Effects of bright lights on cognitive dysfunction as measured by the MoCA	Up to 3 weeks from registration
Effect of bright light on circadian rhythms as measured by core body temperature	Up to 3 weeks from registration
Effects of bright light on ambient light exposure as measured by length of exposure x luminous intensity	Up to 3 weeks from registration
Effects of bright light on sleep disturbance as measured by the PSQI	Up to 3 weeks from registration
Effects of bright light on depression as measured by the PROMIS-Depression	Up to 3 weeks from registration

Trial Locations

Locations (1)

Michigan State University; 🇺🇸 East Lansing, Michigan, United States