Background: Two-thirds of people with advanced cancer experience delirium during hospitalisation.1 Failure to improve delirium is associated with high mortality.2,3 Commonly used antipsychotics lack evidence of effectiveness once delirium develops and may cause harm,4,5 making delirium prevention a priority. Currently, multi-component non-pharmacological strategies are the most effective for reducing delirium.6 However, inclusion of cognitive and exercise components poses adherence challenges, especially in people with advanced cancer. Delirium is associated with sleep disturbances,7 providing a potential therapeutic target. Bright light therapy (BLT) is a non-pharmacological intervention with demonstrated therapeutic benefits that regulate and improve sleep quantity and quality in people with sleep disorders. Recently, BLT has been adopted into the context of delirium, demonstrating some benefit in various hospitalised patient cohorts.8 Further evaluation is warranted, particularly in advanced cancer where little data exists.
Aim: To determine the feasibility and tolerability of BLT in hospitalised adults with advanced cancer.
Method: BLT will be administered for 1 hour every morning for 7 days. The study will collect clinical outcomes data and determine feasibility of collection of correlative endpoints, including sleep quality and duration and salivary melatonin levels, which will underpin mechanistic exploration in future trials. As a pilot feasibility study, an initial target of 10 participants has been set, to inform any study design modifications for a larger Phase II/III study.
Data analysis: Baseline demographic and clinical data will be summarised using descriptive statistics, mean, median, standard deviation and range for continuous variables and frequencies and percentages for categorical variables. Feasibility outcomes will be reported as frequencies and percentages. All participants receiving the first dose of the intervention will be included for safety and tolerability analysis and the data will also be summarised descriptively. An exploratory analysis of melatonin salivary levels will be carried out. Conclusions on the effectiveness of the intervention will be determined in subsequent studies.