NCT02954809

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 3, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
7.3 years until next milestone

Results Posted

Study results publicly available

May 1, 2025

Completed
Last Updated

May 1, 2025

Status Verified

April 1, 2025

Enrollment Period

1.3 years

First QC Date

October 26, 2016

Results QC Date

April 15, 2022

Last Update Submit

April 15, 2025

Conditions

Keywords

fatiguesleep disturbancescircadian activity rhythms

Outcome Measures

Primary Outcomes (1)

  • Study Completion

    The percentage of participants recruited that completed the study

    Baseline

Other Outcomes (9)

  • Changes in Quality of Life With theFunctional Assessment of Cancer Therapy - Lung

    5 weeks

  • Assessment of Environmental Light With Actigraphy (Actiwatch Spectrum Respironics)

    5 weeks

  • Assessement of Chronotype With the Morningness Versus Eveningness Questionnaire

    1 day

  • +6 more other outcomes

Study Arms (2)

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

Attention Control

ACTIVE COMPARATOR

Exposure to dim light delivered with Red-Yellow Re-Timer glasses for 30 minutes in the morning during one week.

Device: Dim light

Interventions

Exposure to morning bright light therapy delivered with Green-Blue Re-Timer glasses for 30 minutes in the morning during one week.

Experimental
Dim lightDEVICE

Exposure to dim light with Red-Yellow Re-Timer glasses for 30 minutes in the morning during one week.

Attention Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Individuals clinically unstable.
  • Mania, Bipolar disease or seizure disorder
  • Macular degeneration or glaucoma.
  • Currently receiving chemotherapy or radiation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SUNY University at Buffalo

Buffalo, New York, 14214, United States

Location

Related Publications (5)

  • Dean GE, Redeker NS, Wang YJ, Rogers AE, Dickerson SS, Steinbrenner LM, Gooneratne NS. Sleep, mood, and quality of life in patients receiving treatment for lung cancer. Oncol Nurs Forum. 2013 Sep;40(5):441-51. doi: 10.1188/13.ONF.441-451.

    PMID: 23989018BACKGROUND
  • Ancoli-Israel S, Rissling M, Neikrug A, Trofimenko V, Natarajan L, Parker BA, Lawton S, Desan P, Liu L. Light treatment prevents fatigue in women undergoing chemotherapy for breast cancer. Support Care Cancer. 2012 Jun;20(6):1211-9. doi: 10.1007/s00520-011-1203-z. Epub 2011 Jun 11.

    PMID: 21660669BACKGROUND
  • Jeste N, Liu L, Rissling M, Trofimenko V, Natarajan L, Parker BA, Ancoli-Israel S. Prevention of quality-of-life deterioration with light therapy is associated with changes in fatigue in women with breast cancer undergoing chemotherapy. Qual Life Res. 2013 Aug;22(6):1239-44. doi: 10.1007/s11136-012-0243-2. Epub 2012 Aug 3.

    PMID: 22865153BACKGROUND
  • Ancoli-Israel S, Liu L, Rissling M, Natarajan L, Neikrug AB, Palmer BW, Mills PJ, Parker BA, Sadler GR, Maglione J. Sleep, fatigue, depression, and circadian activity rhythms in women with breast cancer before and after treatment: a 1-year longitudinal study. Support Care Cancer. 2014 Sep;22(9):2535-45. doi: 10.1007/s00520-014-2204-5. Epub 2014 Apr 15.

    PMID: 24733634BACKGROUND
  • Redd WH, Valdimarsdottir H, Wu LM, Winkel G, Byrne EE, Beltre MA, Liebman ES, Erazo T, Hayes JA, Isola L, Scigliano E, Meschian Y, Lutgendorf S, Ancoli-Israel S. Systematic light exposure in the treatment of cancer-related fatigue: a preliminary study. Psychooncology. 2014 Dec;23(12):1431-4. doi: 10.1002/pon.3553. Epub 2014 May 2. No abstract available.

    PMID: 24798589BACKGROUND

MeSH Terms

Conditions

FatigueParasomniasChronobiology Disorders

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsSleep Wake DisordersNervous System DiseasesMental Disorders

Results Point of Contact

Title
Dr. Carleara Weiss
Organization
University at Buffalo

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 26, 2016

First Posted

November 3, 2016

Study Start

October 1, 2016

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

May 1, 2025

Results First Posted

May 1, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations