Clinical trial NCT03167372: Pilot Comparison of N-of-1 Trials of Light Therapy
Official title: Comparison of N-of-1 Trials of Light Therapy for Depressive Symptoms in Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Health Behavior
Depression
Keywords: Light Therapy
N-of-1
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-05-30
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study aims to assess the feasibility of conducting a randomized trial comparing two N-of-1 trials of light therapy in cancer survivors with depressive symptoms. In the first N-of-1 trial, participants will compare bright white light with dim red light therapy. In the second N-of-1 trial, participants will compare dim white light with dim red light. Participants will be randomized in a 2:1 ratio to either the N-of-1 bright white light vs dim red light experimental arm (N=20) or to a dim white vs dim red light therapy active comparator (N=10).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Protocol Compliance
timeFrame: Length of study (3 months)
measure: Participant Satisfaction
timeFrame: Length of study (3 months)
Secondary outcomes:
measure: Depressive symptoms
timeFrame: Length of study (3 months)
measure: Fatigue
timeFrame: Length of study (3 months)
measure: Side effects
timeFrame: Length of study (3 months)
measure: Physical activity
timeFrame: Length of study (3 months)
measure: Treatment preference for bright white light therapy
timeFrame: Length of study (3 months)
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Ian Kronish, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: