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Healthcare 2020, 8, 10 4 of 14 2.5.2. Side Effects During daily push notifications reminding patients to use the appropriate lightbox, patients were also asked whether they had any side-effects from the lightbox, and if so, to describe them using a free text entry. 2.5.3. Lightbox Preference After completing the personalized trial, patients reviewed the results with the study coordinator, and then stated their preferred treatment (i.e., BWL, DRL, or neither), likelihood of continuing to use the preferred lightbox (1—“not at all likely” to 4—“very likely”), helpfulness of participation in the personalized trial (1—“not at all helpful” to 4—“very helpful”), and how much they would recommend personalized trials of light therapy to other depressed cancer survivors (1—“not at all” to 5—“very much”). 2.5.4. Other Measures At enrollment, patients’ sociodemographic characteristics (age, gender, race, ethnicity, years of education, employment status, health insurance status), cancer history (type of cancer, treatment modalities), depression history (prior diagnosis of depression, use of antidepressants, psychotherapy, or CAM for depression), other medical history (number of medications and comorbid conditions), and preference for shared decision-making [27] were obtained through self-report. At the final interview, patients were asked to describe the ease of using the smartphone application. 2.6. Data Visualization Over the course of the personalized trial, patients could view their average symptom scores per treatment period (Figure A1, Panel a). At the end of the trial, they were provided with a column graph that visualized their average symptoms during the personalized trial, grouped by treatment period (Figure A1, Panel b). Statistically significant differences in symptoms were highlighted by including a checkmark corresponding to the lightbox that resulted in lower symptoms. 2.7. Sample Size Estimate In personalized trials, sample size refers to the number of assessments and treatment periods for each patient. As we had no prior data from which to estimate within-patient day-to-day variability in depressive symptoms nor an expected effect size for depressive symptom reduction when comparing BWL to DRL, we did not calculate statistical power a priori for the number of treatment periods or number of assessments per treatment period. Rather, the sample size for each personalized trial was based on collecting the maximal amount of data expected to be tolerable from the perspective of patient study burden. In prior focus groups assessing patient preferences for the design of personalized trials, a 12-week study duration with 5 min of assessments per day was viewed as the upper limit of what patients would comply with, and this corresponded to the duration and intensity of self-assessments used in this study [17]. 2.8. Statistical Analyses Descriptive statistics were used to describe patients in the study. To determine whether BWL was superior to DRL for reducing depressive symptoms for individual patients, treatment effects were assessed using an autoregressive model that included the type of light therapy as the main exposure, adjusted for time (e.g., days since enrollment) linearly as a covariate, and accounted for autocorrelations of the order 1. Statistical significance was defined as p < 0.05. Given substantial heterogeneity in the within-patient effects of BWL, data were not pooled across patients.PDF Image | Bright White Light Therapy for Depression in Cancer Survivors
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