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Trial registered on ANZCTR


Registration number
ACTRN12624001259538
Ethics application status
Approved
Date submitted
6/09/2024
Date registered
16/10/2024
Date last updated
16/10/2024
Date data sharing statement initially provided
16/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
BEACON: A registry for the collection of patient-reported outcomes and the lived experience of patients with brain tumours.
Scientific title
BEACON: A prospective registry of the patient-reported outcomes and lived experience of patients with brain tumours.
Secondary ID [1] 312907 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain Cancer 335061 0
Condition category
Condition code
Cancer 331570 331570 0 0
Brain

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
5
Target follow-up type
Years
Description of intervention(s) / exposure
To enroll in this study participants must self register to the BEACON portal and complete questionnaires every 3 months on their 1) Diagnosis and treatment, 2)Home supports (3) Quality of life. All data entered will be available to the participant to download after each survey is completed. It is anticipated that the surveys will take between 20 to 30 minutes to complete each time. Access to the internet will be required to complete the questionnaires, either by using a smart phone or a computer at home at a time convenient to the participant. The follow-up period is 5 years.
Intervention code [1] 329440 0
Not applicable
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339309 0
To explore the impact of brain cancer on quality of life.
Timepoint [1] 339309 0
3 monthly for 5 years.
Secondary outcome [1] 439420 0
Explore symptoms of brain cancer
Timepoint [1] 439420 0
3 monthly for 5 years.
Secondary outcome [2] 439421 0
Explore treatment patterns for brain cancer
Timepoint [2] 439421 0
3 monthly for 5 years.

Eligibility
Key inclusion criteria
1. Able to provide informed, voluntary consent in English.
2. Adults aged 18 years and/or above.
3. A brain tumour diagnosis, including but not limited to glioma, meningioma, brain metastases and rare tumours including medulloblastoma and ependymoma.
4. Able to complete online questionnaires with or without the use of a proxy in English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they meet any of the following criteria:
1. Participants who do not have a diagnosis of brain tumour or high clinical suspicion of such
2. Participants who do not have consistent access to a computer/smart phone and internet
3. Participants who are not proficient in reading and writing English
4. Significant cognitive impairment

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/01/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
6/01/2030
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 317339 0
Other Collaborative groups
Name [1] 317339 0
The Walter and Eliza Hall Institute of Medical Research (WEHI)
Country [1] 317339 0
Australia
Primary sponsor type
Other Collaborative groups
Name
The Walter and Eliza Hall Institute of Medical Research (WEHI)
Address
Country
Australia
Secondary sponsor category [1] 319641 0
None
Name [1] 319641 0
Address [1] 319641 0
Country [1] 319641 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316070 0
The Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 316070 0
Ethics committee country [1] 316070 0
Australia
Date submitted for ethics approval [1] 316070 0
25/10/2023
Approval date [1] 316070 0
28/08/2024
Ethics approval number [1] 316070 0
HREC/103541/MH-2023

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

Contacts
Principal investigator
Name 136678 0
Dr Lucy Gately
Address 136678 0
Walter and Eliza Hall Institute of Medical Research 1G Royal Parade Parkville Victoria 3052
Country 136678 0
Australia
Phone 136678 0
+61 3 9345 2747
Fax 136678 0
Email 136678 0
[email protected]
Contact person for public queries
Name 136679 0
Megan Dumas
Address 136679 0
Walter and Eliza Hall Institute of Medical Research 1G Royal Parade Parkville Victoria 3052
Country 136679 0
Australia
Phone 136679 0
+61 3 9348 2747
Fax 136679 0
Email 136679 0
[email protected]
Contact person for scientific queries
Name 136680 0
Megan Dumas
Address 136680 0
Walter and Eliza Hall Institute of Medical Research 1G Royal Parade Parkville Victoria 3052
Country 136680 0
Australia
Phone 136680 0
+61 3 9348 2747
Fax 136680 0
Email 136680 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24169Ethical approval    388405-(Uploaded-05-09-2024-11-48-27)-BEACON_RMH HREC App_Initial_28Aug2024.pdf



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.