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

November 3, 2016 updated by: State University of New York at Buffalo
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14214
        • Recruiting
        • Suny University at Buffalo
        • Contact:
        • Principal Investigator:
          • Carleara Ferreira da Rosa Silva, MS, RN
        • Principal Investigator:
          • Grace E Dean, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

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
Time Frame: 5 weeks
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
Time Frame: 5 Weeks
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
Time Frame: 5 weeks
Comparison of insomnia from pre-test to post-test.
5 weeks
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.
5 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessement of chronotype with the Morningness versus Eveningness Questionnaire
Time Frame: 1 day
Chronotype will be assessed at baseline for a descriptive analysis.
1 day
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
5 weeks
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.
5 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 weeks
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
5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State University of New York at Buffalo

Collaborators

Oncology Nursing Society

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Anticipated)

May 1, 2017

Study Registration Dates

First Submitted

October 26, 2016

First Submitted That Met QC Criteria

November 1, 2016

First Posted (Estimate)

November 3, 2016

Study Record Updates

Last Update Posted (Estimate)

November 4, 2016

Last Update Submitted That Met QC Criteria

November 3, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 030-702786

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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