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

April 15, 2025 updated by: Carleara Weiss, State University of New York at Buffalo
The purpose of this study is to determine the feasibility of a morning bright light therapy intervention for fatigue, sleep disturbances, and circadian activity rhythms in lung cancer survivors.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Carleara Ferreira da Rosa Silva, MS, RN
  • Phone Number: 716-829-3494
  • Email: carleara@buffalo.edu

Study Contact Backup

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14214
        • Suny University at Buffalo

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

  • Primary Purpose: Device Feasibility
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Study Completion
Time Frame: Baseline
The percentage of participants recruited that completed the study
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
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
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
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
State University of New York at Buffalo

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 26, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 3, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 030-702786

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

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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