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

Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02954809
• Other study ID #: 030-702786
• Status: Recruiting
• Phase: N/A
• First received: October 26, 2016
• Last updated: November 3, 2016
• Start date: October 2016

Study information

• Verified date: October 2016
• Source: State University of New York at Buffalo
• Contact: Carleara Ferreira da Rosa Silva, MS, RN
• Phone: 716-829-3494
• Email: carleara[@]buffalo.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Chronobiology Disorders
• Circadian Dysregulation
• Dyssomnias
• Fatigue
• Parasomnias
• Sleep Disturbance
• Sleep Wake Disorders

Intervention

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

Locations

Country	Name	City	State
United States	SUNY University at Buffalo	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
State University of New York at Buffalo	Oncology Nursing Society

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assessment of Visual acuity with the Snellen visual acuity chart	Visual acuity data will be collected and save for safety purposes only at pre-test and post-test.	5 weeks	Yes
Other	Assessment of daytime sleepiness with the Epworth Sleepiness Scale	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	Yes
Primary	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	No
Primary	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	No
Primary	Changes in insomnia with Insomnia Severity Index from pre-test to post-test	Comparison of insomnia from pre-test to post-test.	5 weeks	No
Primary	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	No
Secondary	Assessement of chronotype with the Morningness versus Eveningness Questionnaire	Chronotype will be assessed at baseline for a descriptive analysis.	1 day	No
Secondary	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	No
Secondary	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	No