Comparison of N-of-1 Trials of Light Therapy for Depressive Symptoms in Cancer Survivors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Columbia University
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Protocol Compliance
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •History of cancer (not including basal cell or squamous cell carcinoma, or carcinoma in situ)
- •Current mild to moderate severity depressive symptoms (PHQ-8 score 5 to 19)
- •iPhone user
Exclusion Criteria
- •Has not completed primary cancer treatment including initial chemotherapy, surgical resection, or radiation therapy
- •Non-English speaking
- •Severe depression (PHQ-8 score >=20) or active suicidal ideations
- •Other severe mental illness that would preclude participation in a study that requires extensive self-monitoring, including depression with psychotic features, other psychotic disorder, bipolar disorder, severe personality disorder
- •<6 months life expectancy due to cancer or other severe medical illness
- •Other severe medical illness that would preclude ability to do daily self-tracking
- •Unavailable for follow-up over the course of the 3 month trial
Arms & Interventions
Bright white light vs dim red light
A balanced sequence (ABBA) over a 12 week period of bright white light and dim red light; alternating bright white and dim red light every 3 weeks.
Subjects will receive 2 Litebook® Advantage lightboxes - 1 bright white and 1 dim red. Information such as mood, fatigue, sleep and light therapy side effects will be self-reported using a smartphone diary; physical activity and sleep will also be reported using a Fitbit Flex2 TM. Data visualization at 12 weeks.
Intervention: Litebook® Advantage (Other)
Bright white light vs dim red light
A balanced sequence (ABBA) over a 12 week period of bright white light and dim red light; alternating bright white and dim red light every 3 weeks.
Subjects will receive 2 Litebook® Advantage lightboxes - 1 bright white and 1 dim red. Information such as mood, fatigue, sleep and light therapy side effects will be self-reported using a smartphone diary; physical activity and sleep will also be reported using a Fitbit Flex2 TM. Data visualization at 12 weeks.
Intervention: Fitbit Flex2 TM (Other)
Dim white light vs dim red light
A balanced sequence (ABBA) over a 12 week period of dim white light and dim red light; alternating dim white and dim red light every 3 weeks.
Subjects will receive 2 Litebook® Advantage lightboxes - 1 dim white and 1 dim red. Information such as mood, fatigue, sleep and light therapy side effects will be self-reported using a smartphone diary; physical activity and sleep will also be reported using a Fitbit Flex2 TM. Data visualization at 12 weeks.
Intervention: Litebook® Advantage (Other)
Dim white light vs dim red light
A balanced sequence (ABBA) over a 12 week period of dim white light and dim red light; alternating dim white and dim red light every 3 weeks.
Subjects will receive 2 Litebook® Advantage lightboxes - 1 dim white and 1 dim red. Information such as mood, fatigue, sleep and light therapy side effects will be self-reported using a smartphone diary; physical activity and sleep will also be reported using a Fitbit Flex2 TM. Data visualization at 12 weeks.
Intervention: Fitbit Flex2 TM (Other)
Outcomes
Primary Outcomes
Protocol Compliance
Time Frame: Length of study (3 months)
The proportion of participants randomized to the N-of-1 trial group who are compliant with the N-of-1 trial protocol
Participant Satisfaction
Time Frame: Length of study (3 months)
The proportion of participants randomized to the N-of-1 trial who are satisfied with the N-of-1 trial protocol
Secondary Outcomes
- Depressive symptoms(Length of study (3 months))
- Side effects(Length of study (3 months))
- Treatment preference for bright white light therapy(Length of study (3 months))
- Fatigue(Length of study (3 months))
- Physical activity(Length of study (3 months))
Investigators
Ian Kronish
Associate Professor of Medicine
Columbia University