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Comparison of N-of-1 Trials of Light Therapy for Depressive Symptoms in Cancer Survivors
This study compares the effect of two N-of-1 trials on study compliance with an N-of-1 protocol and on satisfaction with participation in an N-of-1 trial. Using within-person analyses, the study also compares the effect of different types of light therapy on mood, fatigue, sleep, physical activity, and side effects within a mild to moderately depressed cancer survivor population. Ten participants will be randomized to the bright white versus dim red light therapy N-of-1 trial, while the remaining 5 participants will be randomized to a dim white versus dim red light comparator N-of-1 trial.
Fatigue or low energy levels, trouble sleeping and feeling down are symptoms that represent some of the most important concerns in cancer survivors, across a range of cancer types. Despite the impact of these symptoms on quality of life, previous studies have shown that few cancer survivors are receiving adequate treatment for these symptoms. Light therapy involves the use of a light box (a box that lights up) in close proximity for a specified amount of time each day. There can be big differences in the way light therapy affects individual patients. Patients can learn whether this therapy is helpful to them by engaging in an N-of-1 trial. An N-of-1 trial is an experiment conducted with one individual (N refers to "number of individuals in the trial"). In an N-of-1 trial of light therapy, a patient can try light therapy to learn whether it is beneficial to them. All participants will receive two light boxes. The boxes will be labeled "A" and "B." Each light box will emit a different intensity of light. An app will send reminder notifications to participants' smartphones each morning to remind them which light box they should be using, depending on the week. They will be asked to use Box A or Box B each morning for 30 minutes per day for 12 weeks The purpose of this study is to empower cancer survivors with symptoms of fatigue, trouble sleeping or who are feeling down to learn whether light therapy is helpful for them.
Age
21 - No limit years
Sex
ALL
Healthy Volunteers
No
Columbia University Medical Center
New York, New York, United States
Start Date
September 6, 2017
Primary Completion Date
December 31, 2018
Completion Date
December 31, 2018
Last Updated
June 25, 2019
15
ACTUAL participants
Litebook® Advantage
OTHER
Fitbit Flex2 TM
OTHER
Lead Sponsor
Columbia University
Collaborators
NCT05053971
NCT04550494
Data Source & Attribution
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