Effects of Bright Light Therapy on Fatigue, Sleep and Circadian Activity Rhythms in Lung Cancer Survivors

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effects of morning bright light therapy on fatigue, sleep disturbances, and circadian activity rhythms in lung cancer survivors.

Detailed Description
-----------------
A randomized controlled trial to test the effects of morning bright light therapy on fatigue, sleep disturbances, and circadian activity rhythms in lung cancer survivors.

Official Title
-----------------
Effects of Bright Light Therapy on Fatigue, Sleep and Circadian Activity Rhythms in Lung Cancer Survivors

Conditions
-----------------
Fatigue, Sleep Disturbance, Circadian Dysregulation

Intervention / Treatment
-----------------
* Device: Morning bright light therapy
* Device: Dim light


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stage I-III Non-small cell lung cancer survivors Must be at >6-weeks and < 3 years post-surgical resection Must have diagnosis fatigue and/or sleep disturbances Exclusion Criteria: Individuals clinically unstable. Mania, Bipolar disease or seizure disorder Macular degeneration or glaucoma. Currently receiving chemotherapy or radiation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Exposure to morning bright light therapy delivered with Green-Blue Re-Timer glasses for 30 minutes in the morning during one week. | Device: Morning bright light therapy<br>* Exposure to morning bright light therapy delivered with Green-Blue Re-Timer glasses for 30 minutes in the morning during one week.<br>|
| Active Comparator: Attention Control<br>Exposure to dim light delivered with Red-Yellow Re-Timer glasses for 30 minutes in the morning during one week. | Device: Dim light<br>* Exposure to dim light with Red-Yellow Re-Timer glasses for 30 minutes in the morning during one week.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fatigue symptoms with Fatigue Severity Index from pre-test to post-test | Comparison of fatigue severity from pre-test to post-test. | 5 weeks | 
| Change in sleep quality with the Pittsburgh Sleep Quality Index from pre-test to post-test | Comparison of Sleep Quality from pre-test to post-test. | 5 Weeks | 
| Changes in insomnia with Insomnia Severity Index from pre-test to post-test | Comparison of insomnia from pre-test to post-test. | 5 weeks | 
| Change in circadian activity rhythms with actigraphy from pre-test to post-test | Circadian Activity Rhythms will be assessed with actigraphy during the 5-week time frame. | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessement of chronotype with the Morningness versus Eveningness Questionnaire | Chronotype will be assessed at baseline for a descriptive analysis. | 1 day | 
| Assessment of Environmental light with actigraphy (Actiwatch Spectrum Respironics) | Exposure to environmental light will be assessed at pre-test, intervention and post-test for a descriptive analysis | 5 weeks | 
| Changes in Quality of Life with theFunctional Assessment of Cancer Therapy - Lung | Quality of Life will be assessed before, during, and after the intervention. | 5 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fatigue, sleep disturbances, circadian activity rhythms