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.
- light therapy
- multimodal therapy
- psychoeducation sessions
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Deceased KRH since deceased
Correction notice This article has been updated since it was first published online.
Contributors SY, CLC, DB, EB conceived the study. SY, CLC, CE, BL, MD, DGG, MR, JLW, ZL, JO were responsible for conduct of the study including data collection and analysis. SY, EB, CLC, DB, CE, BL, MD, DGG, MR, JLW, ZL, JO, MP, KRH contributed to reporting of the work described in the article including writing of the final draft. SY and EB are guarantors of the study.
Funding SY is supported in part by NCI (1R01CA231521-01A1), NINR (R21 NR016736-01A1) Helsinn Health Care and Genentech (research grant support).
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval The institutional review board of The University of Texas MD Anderson Cancer Center approved this protocol.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available on reasonable request. The study protocol and the analyses are available on reasonable request.
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