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

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ClinicalTrials.gov Identifier: NCT02954809
Recruitment Status : Recruiting
First Posted : November 3, 2016
Last Update Posted : November 4, 2016
Sponsor:
Collaborator:
Oncology Nursing Society
Information provided by (Responsible Party):
State University of New York at Buffalo

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.

Condition or disease Intervention/treatment Phase
Fatigue Sleep Disturbance Circadian Dysregulation Device: Morning bright light therapy Device: Dim light Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: Effects of Bright Light Therapy on Fatigue, Sleep and Circadian Activity Rhythms in Lung Cancer Survivors
Study Start Date : October 2016
Estimated Primary Completion Date : May 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental
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
Exposure to morning bright light therapy delivered with Green-Blue Re-Timer glasses for 30 minutes in the morning during one week.

Active Comparator: Attention Control
Exposure to dim light delivered with Red-Yellow Re-Timer glasses for 30 minutes in the morning during one week.
Device: Dim light
Exposure to dim light with Red-Yellow Re-Timer glasses for 30 minutes in the morning during one week.




Primary Outcome Measures :
  1. Change in fatigue symptoms with Fatigue Severity Index from pre-test to post-test [ Time Frame: 5 weeks ]
    Comparison of fatigue severity from pre-test to post-test.

  2. Change in sleep quality with the Pittsburgh Sleep Quality Index from pre-test to post-test [ Time Frame: 5 Weeks ]
    Comparison of Sleep Quality from pre-test to post-test.

  3. Changes in insomnia with Insomnia Severity Index from pre-test to post-test [ Time Frame: 5 weeks ]
    Comparison of insomnia from pre-test to post-test.

  4. Change in circadian activity rhythms with actigraphy from pre-test to post-test [ Time Frame: 5 weeks ]
    Circadian Activity Rhythms will be assessed with actigraphy during the 5-week time frame.


Secondary Outcome Measures :
  1. Assessement of chronotype with the Morningness versus Eveningness Questionnaire [ Time Frame: 1 day ]
    Chronotype will be assessed at baseline for a descriptive analysis.

  2. Assessment of Environmental light with actigraphy (Actiwatch Spectrum Respironics) [ Time Frame: 5 weeks ]
    Exposure to environmental light will be assessed at pre-test, intervention and post-test for a descriptive analysis

  3. Changes in Quality of Life with theFunctional Assessment of Cancer Therapy - Lung [ Time Frame: 5 weeks ]
    Quality of Life will be assessed before, during, and after the intervention.


Other Outcome Measures:
  1. Assessment of Visual acuity with the Snellen visual acuity chart [ Time Frame: 5 weeks ]
    Visual acuity data will be collected and save for safety purposes only at pre-test and post-test.

  2. Assessment of daytime sleepiness with the Epworth Sleepiness Scale [ Time Frame: 5 weeks ]
    Daytime Sleepiness will be assessed for safety purposes only at pre-test, intervention and post-test. Individuals with high daytime sleepiness and/or at risk of falling asleep while driving or performing hazardous activities will be referred out to primary care



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02954809


Contacts
Contact: Carleara Ferreira da Rosa Silva, MS, RN 716-829-3494 carleara@buffalo.edu
Contact: Grace E Dean, PhD 716-829-3235 gdean@buffalo.edu

Locations
United States, New York
SUNY University at Buffalo Recruiting
Buffalo, New York, United States, 14214
Contact: Carleara Ferreira da Rosa Silva, MS, RN    716-829-3494    carleara@buffalo.edu   
Principal Investigator: Carleara Ferreira da Rosa Silva, MS, RN         
Principal Investigator: Grace E Dean, PhD         
Sponsors and Collaborators
State University of New York at Buffalo
Oncology Nursing Society

Publications:

Responsible Party: State University of New York at Buffalo
ClinicalTrials.gov Identifier: NCT02954809     History of Changes
Other Study ID Numbers: 030-702786
First Posted: November 3, 2016    Key Record Dates
Last Update Posted: November 4, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by State University of New York at Buffalo:
fatigue
sleep disturbances
circadian activity rhythms

Additional relevant MeSH terms:
Fatigue
Dyssomnias
Sleep Wake Disorders
Parasomnias
Chronobiology Disorders
Signs and Symptoms
Nervous System Diseases
Mental Disorders
Neurologic Manifestations