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Healthcare 2020, 8, 10 2 of 14 Keywords: depression; cancer survivor; bright white light therapy; N-of-1 trials; personalized medicine 1. Introduction More than one in five cancer survivors has elevated depressive symptoms, three-fold the prevalence in the general population [1–3]. Depressive symptoms are a major contributor to poor quality of life in cancer survivors [4]. Cancer survivors with depressive symptoms are also at risk of poor adherence to preventive therapies, [5,6] worse prognosis, [7,8], and higher health care costs [9]. Even though evidence for their effectiveness is often lacking, complementary and alternative medicine (CAM) treatments have become increasingly popular among cancer survivors, with up to 80% of cancer survivors reporting CAM use at least once after diagnosis [10–12]. Among CAM treatments for depressive symptoms, there is growing evidence in support of bright white light therapy (BWL) [13]. Recent small randomized clinical trials (RCTs) suggest that BWL may be effective for reducing depressive symptoms and fatigue in cancer survivors [14–16]. RCTs, however, estimate the effect of BWL for the average patient in the trial, and provide limited information on the treatment effect that an individual patient can expect to receive. Personalized trials represent an innovative approach to determining the effectiveness of BWL in cancer survivors [17]. Key features of personalized trials, also known as N-of-1 trials, include a within-subject crossover design with treatment reversals, systematic collection of data on treatment effects, and visualization of data such that patients can share in decision-making about the relative benefits and harms of treatments [18,19]. When conducted successfully, such trials can provide the highest level of evidence for clinical decision-making [20,21]. This design is particularly useful when there is uncertainty regarding whether a treatment is likely to be effective for a given patient [22–24]. Thus, personalized trials can help fill the evidence gap regarding BWL by helping cancer survivors learn, through their own guided experiment, whether BWL is helpful for them. Accordingly, our goal was to conduct a series of personalized trials comparing BWL with dim red light sham treatment (DRL) within individual depressed cancer survivors. The trials were enabled by a smartphone application that was specifically developed for this use case. We hypothesized that there would be heterogeneous effects of BWL on depressive symptoms, with some patients obtaining significant benefits and others finding no benefits in comparison with DRL. 2. Materials and Methods 2.1. Customization of N-of-1Trial Smartphone Application and Electronic Platform We partnered with Overlap Health, Inc. (West Hollywood, Florida) to create a smartphone application for conducting personalized trials of light therapy. The application was designed to (1) guide a patient through a multiple crossover design experiment comparing a bright white (10,000 lux) and a dim red lightbox (50 lux), (2) collect ambulatory assessments of depressive symptoms, fatigue, and side-effects, (3) store and transmit data in a HIPAA-certified manner, (4) aggregate data by treatment period, and (5) visualize data across intervention and sham periods in a manner that helps patients determine whether BWL was effective for them. 2.2. Eligibility, Recruitment, and Consent Implementation of this trial followed the CONSORT (Consolidated Standards of Reporting Trials) 2015 CENT (extension for reporting N-of-1 trials) Statement. (1) Patients were eligible if they were 21 years or older, English speaking, and used an iOS smartphone (i.e., iPhone), a requirement for using the application. Patients also had to have at least mild depressive symptoms (eight-item patient health questionnaire (PHQ-8) score 5–24). (2) Patients who reported suicidal ideations or a history ofPDF Image | Bright White Light Therapy for Depression in Cancer Survivors
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