TY - JOUR T1 - Sleep disturbance in patients with cancer: a feasibility study of multimodal therapy JF - BMJ Supportive & Palliative Care JO - BMJ Support Palliat Care SP - 170 LP - 179 DO - 10.1136/bmjspcare-2019-001877 VL - 11 IS - 2 AU - Sriram Yennurajalingam AU - Cindy Carmack AU - Dave Balachandran AU - Cathy Eng AU - Bora Lim AU - Marvin Delgado AU - Diana Guzman Gutierrez AU - Monica Raznahan AU - Minjeong Park AU - Kenneth R Hess AU - Janet L Williams AU - Zhanni Lu AU - Jewel Ochoa AU - Eduardo Bruera Y1 - 2021/06/01 UR - http://spcare.bmj.com/content/11/2/170.abstract N2 - Background Our aim was to determine feasibility and effect sizes of bright light therapy (BLT), melatonin (MLT), methylphenidate (MP) and eight combinations (BLT+MLT+MP, BLT+MLT, BLT+MP, BLT alone, MLT+MP, MLT alone, MP alone, placebo for BLT, MLT and MP) defined as multimodal therapy (MMT), to improve sleep quality (SQ) (Pittsburgh Sleep Quality Index (PSQI)) from baseline to day 15. We also examined the effects of MMT on insomnia, fatigue, depression, quality of life and actigraphy.Methods Patients with advanced cancer with poor SQ (PSQI ≥5) were eligible. Using a double-blind randomised factorial study design, patients were randomised into 1 of the 8 arms for 2 weeks. Feasibility and effect sizes were assessed.Results 81% (54/67) of randomised patients completed the study. There were no differences in the demographics and SQ between groups. The adherence rates for BLT, MLT and MP were 93%, 100% and 100%, respectively. BLT+MLT+placebo of MP; BLT+placebo of MLT+placebo of MP; BLT+MLT+MP showed an effect size (Cohen’s d) for change in PSQI scores of 0.64, 0.57 and 0.63, respectively. PSQI change using linear regression showed BLT (n=29) has effect size of 0.46, p=0.017; MLT (n=26), 0.24, p=0.20; MP (n=26), 0.06, p=0.46. No significant differences were observed in scores for insomnia, fatigue, depression, quality of life and actigraphy. There were no differences in adverse events by groups(p=0.80).Conclusions The use of MMT to treat SQ disturbance was feasible. BLT+MLT showed the most promising effect size in improvement in SQ, and additional larger studies are needed.Trial registration number NCT01628029.Data are available on reasonable request. The study protocol and the analyses are available on reasonable request. ER -