Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001494527
Ethics application status
Approved
Date submitted
2/12/2024
Date registered
20/12/2024
Date last updated
20/12/2024
Date data sharing statement initially provided
20/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
BOLDER: Breast cancer decision making and outcomes in OLDER Australians
Scientific title
BOLDER: Breast cancer decision making and outcomes in OLDER Australians
Secondary ID [1] 313504 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
breast cancer 335933 0
geriatric oncology 335934 0
Condition category
Condition code
Cancer 332519 332519 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a non interventional study.

All patients will undergo a screening geriatric questionnaire (G8), anticipated to take 5-10 minutes, prior to their medical oncology appointment. During their medical oncology appointment where they will decide on first-line treatment for metastatic hormone positive breast cancer, patients will also undergo a timed up and go, mini-Cog +/- electronic rapid fitness assessment (eRFA) with the clinician, depending on their score on the G8. This should take about 15-30 minutes.

This study is assessing the factors that have influenced clinician and patient decisions regarding their first-line treatment choice using surveys (both will complete a survey within the first 6 weeks of the geriatric assessment, clinicians will complete a second survey at 6 months). The surveys should take about 5-10 minutes each.
Intervention code [1] 330075 0
Not applicable
Comparator / control treatment
There is no intervention in this study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340038 0
To assess the clinical utility of a previously validated collection of geriatric assessment tools and its impact on clinicians’ treatment recommendations for first-line therapy (these will be assessed as a composite primary outcome)
Timepoint [1] 340038 0
The patient survey and the first clinician survey will be completed within 6 weeks of the first oncology appointment where the clinician and patient complete the geriatric assessment and decide on first-line treatment. The second clinician survey will be completed in 6 months.
Primary outcome [2] 340039 0
To determine factors influencing clinician treatment recommendations for first-line systemic treatment in patients aged 70 or older with newly or recently diagnosed HR+, HER2- ABC in Australia
Timepoint [2] 340039 0
The first clinician survey will be completed within 6 weeks of the initial appointment where the clinician and patient complete the geriatric assessment and decide on first-line treatment. The second clinician survey will be completed at 6 months.
Secondary outcome [1] 442459 0
To examine the feasibility of performing a geriatric assessment prior to making first-line treatment decisions in HR+ ABC
Timepoint [1] 442459 0
up to 6 weeks prior to oncology appointment (when patient component of geriatric assessment is done), at the time of first oncology appointment (when geriatric assessment is completed with the clinician), at follow-up oncology appointment (6 weeks post first appointment)
Secondary outcome [2] 442460 0
Treatment selection of first-line systemic treatment in the real-world cohort
Timepoint [2] 442460 0
at follow up appointment (within 4-6 weeks post first appointment)
Secondary outcome [3] 442462 0
Determine factors influencing patient decision-making in selection of first-line systemic therapy
Timepoint [3] 442462 0
Factors assessed include risk of side effects, medical comorbidities, polypharmacy, finance, distance to the hospital, time away from family. These will be assessed using the patient survey within 6 weeks of the first oncology appointment (where first-line treatment is decided)
Secondary outcome [4] 442830 0
Duration of first-line treatment
Timepoint [4] 442830 0
baseline, at 4-6 weeks, at 6 months, then typically 3 monthly follow-ups thereafter (but up to the clinician's decision)
Secondary outcome [5] 442831 0
Progression free survival
Timepoint [5] 442831 0
baseline, at 4-6 weeks, at 6 months, then typically 3 monthly follow-ups thereafter (but up to the clinician's decision)
Secondary outcome [6] 442832 0
Rate of adverse events that result in first-line treatment dose reduction and/or discontinuation
Timepoint [6] 442832 0
at 4-6 weeks, at 6 months, then typically 3 monthly follow-ups thereafter (but up to the clinician's decision)
Secondary outcome [7] 442833 0
Referrals to supportive care services
Timepoint [7] 442833 0
at 6 months (post commencement of 1st line treatment)

Eligibility
Key inclusion criteria
Patients aged 70 years or older, of any gender and performance status diagnosed with metastatic, or inoperable histologically confirmed HR+, HER2- breast cancer (either de novo metastatic or relapsed).
Decisions about first-line therapy not yet made at the time of consent.
Patients must be willing and able (with assistance if needed) to fill out forms/ surveys and complete the self-reported geriatric assessment
Minimum age
70 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
not meeting inclusion criteria

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/02/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 317952 0
Other Collaborative groups
Name [1] 317952 0
VCCC Alliance: strategies program 4
Country [1] 317952 0
Australia
Funding source category [2] 317953 0
Other Collaborative groups
Name [2] 317953 0
ReVitalise/Regional Trials Network Registry Trials project.
Country [2] 317953 0
Australia
Primary sponsor type
Other
Name
Walter and Eliza Hall Institute of Medical Research
Address
Country
Australia
Secondary sponsor category [1] 320290 0
None
Name [1] 320290 0
Address [1] 320290 0
Country [1] 320290 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316628 0
The Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 316628 0
Ethics committee country [1] 316628 0
Australia
Date submitted for ethics approval [1] 316628 0
30/10/2024
Approval date [1] 316628 0
13/11/2024
Ethics approval number [1] 316628 0
HREC/109499/MH-2024

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

Contacts
Principal investigator
Name 138458 0
Dr Vanessa Wong
Address 138458 0
Walter and Eliza Hall Institute/1G Royal Parade, Parkville VIC 3052
Country 138458 0
Australia
Phone 138458 0
+61 3 9345 2555
Fax 138458 0
Email 138458 0
wong.v@wehi.edu.au
Contact person for public queries
Name 138459 0
Vanessa Wong
Address 138459 0
Walter and Eliza Hall Institute/1G Royal Parade, Parkville VIC 3052
Country 138459 0
Australia
Phone 138459 0
+61 3 9345 2555
Fax 138459 0
Email 138459 0
wong.v@wehi.edu.au
Contact person for scientific queries
Name 138460 0
Vanessa Wong
Address 138460 0
Walter and Eliza Hall Institute/1G Royal Parade, Parkville VIC 3052
Country 138460 0
Australia
Phone 138460 0
+61 3 9345 2555
Fax 138460 0
Email 138460 0
wong.v@wehi.edu.au

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?

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.