Clinical trial NCT02954809: Feasibility of Bright Light Therapy on Fatigue, Sleep and Circadian Activity Rhythms in Lung Cancer Survivors
Official title: Feasibility of Bright Light Therapy on Fatigue, Sleep and Circadian Activity Rhythms in Lung Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Sleep Disturbance
Circadian Dysregulation
Keywords: fatigue
sleep disturbances
circadian activity rhythms
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: Oncology Nursing Society
First posted: 2016-11-03
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

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.

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.

Eligibility 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.

Primary outcomes:
measure: Study Completion
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
measure: Changes in Quality of Life With theFunctional Assessment of Cancer Therapy - Lung
timeFrame: 5 weeks
measure: Assessment of Environmental Light With Actigraphy (Actiwatch Spectrum Respironics)
timeFrame: 5 weeks
measure: Assessement of Chronotype With the Morningness Versus Eveningness Questionnaire
timeFrame: 1 day
measure: Change in Fatigue Symptoms With Fatigue Severity Index From Pre-test to Post-test
timeFrame: 5 weeks
measure: Change in Sleep Quality With the Pittsburgh Sleep Quality Index From Pre-test to Post-test
timeFrame: 5 Weeks
measure: Changes in Insomnia With Insomnia Severity Index From Pre-test to Post-test
timeFrame: 5 weeks
measure: Change in Circadian Activity Rhythms With Actigraphy From Pre-test to Post-test
timeFrame: 5 weeks
measure: Assessment of Visual Acuity With the Snellen Visual Acuity Chart
timeFrame: 5 weeks
measure: Assessment of Daytime Sleepiness With the Epworth Sleepiness Scale
timeFrame: 5 weeks
Locations:
city: Buffalo
country: United States
facility: SUNY University at Buffalo
state: New York
Study officials:
References:
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.
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. Epub 2011 Jun 11.
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. Epub 2012 Aug 3.
citation: 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.
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. Epub 2014 May 2. No abstract available.