Multimodal therapy for the treatment of sleep disturbance in patients with advanced cancer.

185 Background: Poor sleep quality is frequent in patients with advanced cancer (62%), and is associated with a severe symptom distress and mortality. There are limited evidence based treatment options in advanced cancer patients.To obtain feasibility, preliminary estimates of the effects of various treatments [light therapy, melatonin, Methylphenidate] and combinations of treatments in multimodal therapy (MMT) to improve sleep quality, as measured by change in Pittsburg Sleep Quality Index (PSQI) scores from baseline to Day 15. We also examined MMT effects on FACT-G, insomnia - Insomnia severity index (ISI), actigraphy. Methods: Cancer patients with moderate sleep disturbance were eligible. Using a double-blind (patient, investigators) randomized factorial study design, eligible Pts were randomized into 1 of the 8 arms of the study which included all possible combinations of the interventions (light therapy, melatonin, and methylphenidate) and/or their corresponding placebo treatments for a duration of 2 weeks. All patients received 3 sessions of standardized CBT. Linear regression analysis was used to assess treatment effects. Results: 84% (54/ 64) randomized Pts were evaluable. At baseline, median (IQR) total PSQI was 13 (12, 15); and ISI was 18 (14, 21). There were no differences in the demographics and baseline sleep quality between groups. The adherence rates for light therapy, melatonin, and methylphenidate were 93%, 100%, and 100% respectively. Light therapy had moderate effects on sleep quality (effect size .43, P=0.017). No significant differences in ISI, FACT-G scores, and objective sleep variables between groups. There were no significant difference in adverse events by groups (P=.97). Conclusions: MMT interventions to treat sleep disturbance were feasible. Light therapy provided the best signal for improvement in sleep quality, and should proceed to large randomized control trials. Clinical trial information: NCT0168029. [Table: see text]