TY - JOUR
T1 - Sleep disturbance in patients with cancer
T2 - A feasibility study of multimodal therapy
AU - Yennurajalingam, Sriram
AU - Carmack, Cindy
AU - Balachandran, Dave
AU - Eng, Cathy
AU - Lim, Bora
AU - Delgado, Marvin
AU - Guzman Gutierrez, DIana
AU - Raznahan, Monica
AU - Park, Minjeong
AU - Hess, Kenneth R.
AU - Williams, Janet L.
AU - Lu, Zhanni
AU - Ochoa, Jewel
AU - Bruera, Eduardo
N1 - Publisher Copyright:
© 2021 BMJ Publishing Group. All rights reserved.
PY - 2021/6/1
Y1 - 2021/6/1
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.
AB - 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.
KW - cancer
KW - light therapy
KW - melatonin
KW - methylphenidate
KW - multimodal therapy
KW - psychoeducation sessions
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U2 - 10.1136/bmjspcare-2019-001877
DO - 10.1136/bmjspcare-2019-001877
M3 - Article
C2 - 31924662
AN - SCOPUS:85078314917
SN - 2045-435X
VL - 11
SP - 170
EP - 179
JO - BMJ Supportive and Palliative Care
JF - BMJ Supportive and Palliative Care
IS - 2
ER -