Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000257460
Ethics application status
Approved
Date submitted
11/11/2024
Date registered
8/04/2025
Date last updated
8/04/2025
Date data sharing statement initially provided
8/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
BLiPD: Assessing the feasibility and tolerability of bright light therapy for delirium prevention in hospitalised adults with advanced cancer
Scientific title
Randomised, open-label, controlled pilot trial of Bright Light therapy for the Prevention of Delirium in hospitalised adults with advanced cancer (BLiPD)
Secondary ID [1] 313030 0
Nil known
Universal Trial Number (UTN)
Trial acronym
BLiPD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Delirium 335247 0
Advanced cancer 336422 0
Condition category
Condition code
Cancer 331804 331804 0 0
Any cancer
Neurological 332943 332943 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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™?
Intervention code [1] 329578 0
Prevention
Intervention code [2] 330382 0
Treatment: Devices
Comparator / control treatment
Standardized supportive care will be provided in accordance with recommendations in the National Institute for Health and Care Excellence (NICE) Delirium Clinical Guidance. This includes assessment of patients' readiness for and coordination of an exercise program, access to hearing aids/glasses, sleep preservation techniques and reorientation. Light exposure will be minimized from 11:00pm to 6:30 am to standardized light exposure, to help maintain normal sleep pattern in the hospital environment. Standardized support care will be provided up to 7 days starting after admission, or until delirium occurrence, discharge or death.
Control group
Active

Outcomes
Primary outcome [1] 339443 0
Feasibility of Re-Timer (experimental arm only)
Timepoint [1] 339443 0
The primary endpoint is the rate of full completion of the study intervention, defined as a single continuous time of 60 minutes of BLT, between 7:00am and 10:00am, for the first seven consecutive days (the time period in which most delirium episodes during an acute admission would occur), or until delirium occurrence, hospital discharge, or death (whichever comes first). A partial completion will be recorded for participants that receive at least 45 minutes of BLT, between 7:00am and 10:00am, for at least 80% of their admission.
Secondary outcome [1] 440008 0
Safety events of interest (experimental arm only)
Timepoint [1] 440008 0
Safety events of interest, as measured by the NCI-CTCAE 5.0, will be measured daily by the research nurse from Days 1 through 7 post intervention commencement. Participants that remain in hospital beyond Day 7 will continually be assessed for delirium each shift until Day 14, hospital discharge, or death (whichever comes first).
Secondary outcome [2] 440009 0
Delirium incidence
Timepoint [2] 440009 0
Delirium incidence will be measured by each nursing shift (three time per day) by ward nurses from Days 1 through 7 post intervention commencement. Participants that remain in hospital beyond Day 7 will continually be assessed for delirium each shift until Day 14, hospital discharge, or death (whichever comes first).
Secondary outcome [3] 440010 0
Melatonin assessments
Timepoint [3] 440010 0
Changes in melatonin salivary levels on Day 1 and Day 4 (or exit, whichever comes first) post intervention commencement.
Secondary outcome [4] 440011 0
Sleep quality
Timepoint [4] 440011 0
The ISI will be assessed at baseline (Day 0) and every seven days (i.e., Day 7 and Day 14 if participant continues into the extension phase) post intervention commencement, and upon discharge (modified for seven-day recall period) to describe changes in sleep quality from baseline (Day 0 - when participants are screened for eligibility).
Secondary outcome [5] 440012 0
In-hospital resource utilisation
Timepoint [5] 440012 0
The research nurse will complete a daily eCRF to collect time (minutes per day), participant length of stay (days) and ancillary resources needed to assist each participant in the treatment arm with intervention from Days 1-7 post intervention commencement. This will be supplemented by retrospective medical file review for cross-validation of participant length of stay (days) and other resources needed, on Day 7 (post intervention commencement), withdrawal, discharge or death (whichever comes first).
Secondary outcome [6] 440013 0
Feasibility of the study design (Particiapnt experience - experimental arm only)
Timepoint [6] 440013 0
One-on-one semi-structured interviews with participants (experimental arm only) during the intervention (between Days 2-7 post intervention commencement) will be conducted by the research nurse.
Secondary outcome [7] 443822 0
Reasons for treatment cessation (experimental arm only)
Timepoint [7] 443822 0
Reasons for intervention cessation or discontinuation will be measured daily by the research nurse from Days 1 through 7 post intervention commencement. Participants that choose to enter the extension phase (Days 7-14) will continually be assessed for this outcome.
Secondary outcome [8] 443823 0
Time to treatment discontinuation (TTD)
Timepoint [8] 443823 0
TTD will be measured daily by the research nurse from Days 1 through 7 post intervention commencement. Participants that choose to enter the extension phase (Days 7-14) will continually be assessed for this outcome.
Secondary outcome [9] 443824 0
Delirium confirmation
Timepoint [9] 443824 0
The CAM-long will be used to screen participants for eligibility (Day 0) and to confirm delirium episodes identified through the NuDESC screening assessments as detailed above from Days 1 through 7 post intervention commencement. Participants that remain in hospital beyond Day 7 will continually be assessed for delirium outcomes daily until Day 14, hospital discharge, or death (whichever comes first).
Secondary outcome [10] 443825 0
Delirium severity
Timepoint [10] 443825 0
Delirium severity (via the DRS-R-98) will be measured only if a patient screens positive for delirium using the NuDESC and is confirmed by the CAM-long from Days 1 through 7 post intervention commencement. Participants that remain in hospital beyond Day 7 will continually be assessed for delirium outcomes daily until Day 14, hospital discharge, or death (whichever comes first).
Secondary outcome [11] 443829 0
Delirium Aetiology Checklist
Timepoint [11] 443829 0
The DEC will be measured only once a patient screens positive for delirium using the NuDESC and is confirmed by the CAM-long from Days 1 through 7 post intervention commencement. Participants that remain in hospital beyond Day 7 will continually be assessed for delirium outcomes daily until Day 14, hospital discharge, or death (whichever comes first).
Secondary outcome [12] 443830 0
Performance status
Timepoint [12] 443830 0
The AKPS will be collected upon hospital admission for eligibility and baseline measures (i.e., Day 0), Day 7 post intervention commencement, upon delirium occurrence, and upon discharge/withdrawal/death.
Secondary outcome [13] 443832 0
Cognitive impairment
Timepoint [13] 443832 0
The SBT will be assessed upon admission to hospital (i.e., Day 0) only for participants who have a clinical diagnosis of moderate to severe dementia to confirm eligibility, and upon discharge/withdrawal/death post intervention commencement.
Secondary outcome [14] 443834 0
Total sleep time
Timepoint [14] 443834 0
The research nurse will download metrics from the GENEActiveTM app on Day 7 and record patients total sleep time during days 1-7 post intervention commencement.
Secondary outcome [15] 443835 0
Obstructive sleep apnea risk
Timepoint [15] 443835 0
Participants will complete the STOP-Bang questionnaire at baseline (Day 0) to identify individuals at risk for OSA.
Secondary outcome [16] 443836 0
Quality of Life
Timepoint [16] 443836 0
Participants will complete at the questionnaire baseline (Day 0) and at the end of intervention (Day 7) or upon discharge (whichever comes first) and compared to baseline measures to inform feasibility of using this instrument to derive utility weights in future cost effectiveness analyses.
Secondary outcome [17] 443844 0
Feasibility of the study design (staff perspective)
Timepoint [17] 443844 0
Two focus groups will take place at each participating site. The first will be conducted halfway through the study (roughly after n=28 participants have engaged with the study) and the second upon study completion (1 month post participants enrolment).
Secondary outcome [18] 444327 0
Self-reported day-time sleep habits
Timepoint [18] 444327 0
Patient's will complete a daily eCRF from Days 1, post intervention commencement, until Day 7, hospital discharge, or death (whichever comes first). Participants that remain in hospital beyond Day 7 will continually be asked to complete the daily self-reported day-time sleep habits until hospital discharge, cessation or death (whichever comes first).

Eligibility
Key inclusion criteria
Adult (18 years or older);

Diagnosis of advanced cancer (which can be confirmed clinically, by imaging and/or with histopathology);

Being admitted to a palliative or oncology unit at participating investigational sites;

Participant can complete assessments and comply with the study procedures; and

Participant is able to give fully informed written consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Delirium on admission, according to criteria on Confusion Assessment Method – Long form. (CAM-long)

Moderate to severe dementia on admission defined as a clinical diagnosis with a Short-Blessed Test (SBT) score =10

Contraindications to use and/or tolerance of Re-Timer™ device, as per Supplementary Document S1 The Re-Timer™ medical manual, include: photosensitive skin disorders of the face, use of photosensitising medications, severe eye disorders within significantly impaired vision or photophobia (e.g., retinal blindness, severe cataract, severe glaucoma, severe macular degeneration), current diagnosis of bipolar disorder, active seizure disorders within last 30 days, and claustrophobia which in view of participant would prohibit tolerance of device

Australian-modified Karnofsky performance score (AKPS) less than 30 upon admission to hospital

Other key diagnostic, pre-existing condition, medication or physical attribute which would exclude the person from participating in the study on the basis of safety, ability to provide key data or other reasons.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be achieved by employing block randomisation and central randomisation mechanisms. Block randomisation creates balanced groups of participants by assigning them in fixed-size blocks, preventing prediction of future assignments. Central randomisation, managed through REDCap, further enhances concealment by handling the randomisation process off-site. This method ensures that neither the participants, site staff nor the researchers can influence or predict the allocation sequence, maintaining the integrity of the trial and reducing selection bias. Together, these techniques provide a robust framework for maintaining randomisation and concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation sequence will be generated using the REDCap (Research Electronic Data Capture) database randomisation tool. Block randomisation will occur at each site in randomly assigned blocks of four in a 1:1 ratio.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
All data analysis will be performed using IBM Statistical Package for the Social Sciences (SPSS) (version 27) software (IBM Corp, Released 2020). Baseline demographic and clinical data will be summarised using descriptive statistics, mean, median, standard deviation and interquartile range for continuous variables and frequencies and percentages for categorical variables. Comparisons between the two arms will be conducted using appropriate statistical tests. For continuous variables, independent samples t-tests (or Mann-Whitney U tests for non-normally distributed data) will be used. For categorical variables, Chi-square tests (or Fisher's exact tests for small sample sizes) will be used. All statistical analyses will be performed using a significance level of 0.05, and results will be reported with 95% confidence intervals where applicable.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/05/2025
Actual
Date of last participant enrolment
Anticipated
4/05/2029
Actual
Date of last data collection
Anticipated
21/05/2029
Actual
Sample size
Target
56
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 317470 0
Other Collaborative groups
Name [1] 317470 0
NIDUS
Country [1] 317470 0
United States of America
Funding source category [2] 317522 0
University
Name [2] 317522 0
University of Technology Sydney
Country [2] 317522 0
Australia
Primary sponsor type
University
Name
University of Technology Sydney
Address
Country
Australia
Secondary sponsor category [1] 319763 0
None
Name [1] 319763 0
Address [1] 319763 0
Country [1] 319763 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316187 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 316187 0
Ethics committee country [1] 316187 0
Australia
Date submitted for ethics approval [1] 316187 0
27/05/2024
Approval date [1] 316187 0
31/07/2024
Ethics approval number [1] 316187 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137066 0
Dr Rayan Saleh Moussa
Address 137066 0
Cancer Symptoms Trials, University of Technology Sydney, 15 Broadway, Ultimo NSW 2007
Country 137066 0
Australia
Phone 137066 0
+61 423251710
Fax 137066 0
Email 137066 0
[email protected]
Contact person for public queries
Name 137067 0
Rayan Saleh Moussa
Address 137067 0
Cancer Symptoms Trials, University of Technology Sydney, 15 Broadway, Ultimo NSW 2007
Country 137067 0
Australia
Phone 137067 0
+61 423251710
Fax 137067 0
Email 137067 0
[email protected]
Contact person for scientific queries
Name 137068 0
Rayan Saleh Moussa
Address 137068 0
Cancer Symptoms Trials, University of Technology Sydney, 15 Broadway, Ultimo NSW 2007
Country 137068 0
Australia
Phone 137068 0
+61 423251710
Fax 137068 0
Email 137068 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
What individual participant data might be shared?
• Individual participant data that underlie the results reported in the primary publication, after de-identification (text, tables, figures and appendices) will be available.

What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Health economic analyses
• Studies testing whether findings can be repeated or confirmed
• Teaching research methods or developing new statistical techniques
• Data will be available for analysis to achieve the aims in the approved proposal.

When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Contacting the Chief Investigator (CI) Rayan Saleh Moussa - phone: 0423251710; email: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.