BLiPD: Assessing the feasibility and tolerability of bright light therapy for delirium prevention in hospitalised adults with advanced cancer

Commencing the morning after randomisation, the Re-Timer™ device will be applied for a single continuous time of 60 minutes starting between 7:00am and 9:00am (to finish no later than 10:00am) daily, until delirium occurrence, discharge, death or a minimum of seven days if the participant remains in hospital. To accommodate for participant schedules, we have provided a flexible dosing period (starting from 7:00am-9:00am, to finish no later than 10:00am), allowing participants and staff to select the most suitable time for the intervention. We will encourage consistency by using the device as close to the participants wake time as possible, applying the Re-Timer device at approximately the same time each day, ideally matching the start time on Day 1. We will collect data on start times and record any reasons for significant changes on the daily eCRF completed by the research nurse. In addition, standardised supportive care, according to NICE delirium clinical guidelines will be provided, as well as standardised evening light exposure, defined as dimmed hospital room lighting from 11:00pm until the next morning at 6:30am, for the duration of treatment. The Re-Timer™ device will be worn like a pair of spectacles, emitting 500 lux of green/blue light and has a wavelength of 500 nanometres (nm), that is emitted directly into each eye. Patient protocol Prior to application, the research nurse will enter room, rousing the participant and sitting them in an upright position in bed, where they will remain for the duration of the treatment. The research nurse will turn on the device, select the high brightness setting and place it on the participants head like a pair of spectacles. If the participant wishes to wear their glasses while using the Re-Timer, the research nurse will assist putting their usual glasses on first, if needed, then placing the Re-Timer over the top. During treatment, participants are free to engage in usual activities such as reading, watching TV, eating breakfast etc. The research will remind participants each dose that they are to remain seated during treatment (i.e., not to walk around the room) and they must keep their eyes open (e.g., no sleeping or resting with eyes shut). The Re-Timer device will automatically switch off after 60 minutes of use. If the participant requests to turn off the Re-Timer before 60 minutes, the research nurse will remove it from their head first and turn it off, documenting stop time and reasons for deviations to treatment protocol in the daily eCRF. Study participants randomised to the experimental group have the option to continue using the study intervention beyond the minimum treatment period of seven days if their hospital admission is ongoing. All study participants that remain in hospital beyond Day 7 will continually be assessed daily according to the assessment schedule, as previously detailed, until Day 14, discharge, or death (whichever comes first). For experimental participants, the following data will be collected daily during Day 1-7 or 8-14 if continuing into extension phase, discharge or death: - Duration of treatment (min) - Time to treatment discontinuation (days) - Treatment start time. Reasons for significant changes in start time will be documented by the research nurse in the Data Collection Worksheet and eCRF. One-on-one participant semi-structured interviews will be conducted in the participants room by the research nurse. The interviews will be audio recorded and analysed using thematic content analysis to identify emergent themes and trends related to participants’ perceptions of the tolerability and acceptability of the Re-Timer device. These discussions will take place between Days 2-7 post intervention commencement. An informal topic guide was created to help guide the discussions. Question in the topic guide include: Why did you choose to participate in this study? What did you know about delirium prior to participating in this study? Do you have any feedback regarding the information you received about the study? (Prompts: was the information provided about the study sufficient, and if not, what additional details would you have liked to receive?) Do you have any feedback about the PICF? (Prompt: did it clearly outline what the study involved? How can we improve the PICF?) Do you have any feedback about the baseline assessments? Describe your experience using the Re-Timer™ Device. (Prompts: What did you like or not like about using the device? Was the device easy to use? Did you run into any technical issues? Was the timing of use appropriate?) Describe any symptoms you experienced while using the Re-Timer™ device? How long did these symptoms last? (Prompts: headaches, blurred vision, irritability, anxiety) Have you noticed any other changes, good or bad, that you may attribute to using the Re-Timer™ device? (Prompts: sleep quality, energy or fatigue levels, mood changes, eating and other) Do you think the Re-Timer™ device was helpful? Why/why not? Do you have any feedback about the study measures? (Prompt: what did you like or not like about the study measures) Describe your experience with the evening saliva sampling. Do you have any suggestions on ways to make this study more practical for future participants? Do you have any further comments or questions you would like to raise about this study or the Re-Timer™?