Clinical trial · Interventional
Effects of Bright Light on Co-occurring Cancer-related Symptoms in Breast Cancer Survivors
Effects of Bright Light on Co-occurring Cancer-related Symptoms in Breast Cancer Survivors: A Personalized Intervention
NCT03304587CI-TRIAL-00090827completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (14)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bright blue-green light | Other | — | UNRESOLVED |
| Center for Epidemiological Studies - Depression | Other | — | UNRESOLVED |
| Daily Log | Other | — | UNRESOLVED |
| Digital foot candle datalogging light meter | Diagnostic Test | — | UNRESOLVED |
| Dim red light | Other | — | UNRESOLVED |
| European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire (EORTC QLQ-C30) | Other | — | UNRESOLVED |
| Montreal Cognitive Assessment (MoCA) | Other | — | UNRESOLVED |
| Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer-Fatigue |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1: Bright blue-green light
- description
- * 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
- interventionNames
- 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)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
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)
References
Publications (2)
- DERIVEDWu HS, Gao F, Davis JE, Given CW. Effects of chronotype-tailored bright light intervention on post-treatment symptoms and quality of life in breast cancer survivors. Support Care Cancer. 2023 Nov 17;31(12):705. doi: 10.1007/s00520-023-08157-9. PMID 37975923
- DERIVEDWu HS, Gao F, Davis JE, Given CW. Effects of Chronotype-tailored Bright Light Intervention on Symptoms and Quality of Life in Breast Cancer Survivors. Res Sq [Preprint]. 2023 Aug 25:rs.3.rs-3286350. doi: 10.21203/rs.3.rs-3286350/v1. PMID 37674711