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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
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Scientific title
BOLDER: Breast cancer decision making and outcomes in OLDER Australians
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Secondary ID [1]
313504
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
breast cancer
335933
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geriatric oncology
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Condition category
Condition code
Cancer
332519
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0
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Breast
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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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.
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Intervention code [1]
330075
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Not applicable
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Comparator / control treatment
There is no intervention in this study.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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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
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Assessment method [1]
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Factors influencing clinician treatment recommendations for first-line therapy will be explored through the clinician survey. All of the surveys used in this study have been designed specifically for the BOLDER study.
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Timepoint [1]
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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.
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Primary outcome [2]
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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)
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Assessment method [2]
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The clinical utility of the geriatric assessment tools will be evaluated through clinician and patient surveys (surveys have been designed specifically for this study). The impact of the geriatric assessment tool(s) on clinician's treatment recommendation will be assessed through the aforementioned clinician surveys. The assessment tool will be considered clinically useful if it is deemed appropriate, accessible, practical and acceptable according to the Oxford Clinical Utility Framework.
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Timepoint [2]
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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.
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Secondary outcome [1]
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To examine the feasibility of performing a geriatric assessment prior to making first-line treatment decisions in HR+ ABC
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Assessment method [1]
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Recruitment rate (measured by the proportion of eligible patients that were screened and subsequently enrolled on this study), geriatric assessment completion rate, and dropout rates at each stage of the study (G8, eRFA). These will be assessed as a composite outcome via audit of study enrolment and withdrawal logs.
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Timepoint [1]
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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)
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Secondary outcome [2]
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Determine factors influencing patient decision-making in selection of first-line systemic therapy
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Assessment method [2]
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Factors influencing patient decision-making in selection of first-line therapy will be assessed using the patient survey (designed specifically for this study)
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Timepoint [2]
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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)
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Secondary outcome [3]
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Treatment selection of first-line systemic treatment in the real-world cohort
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Assessment method [3]
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Assessment by review of participants' medical records
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Timepoint [3]
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at follow up appointment (within 4-6 weeks post first appointment)
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Secondary outcome [4]
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Duration of first-line treatment
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Assessment method [4]
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Time from commencement of treatment to cessation of treatment or death, whichever comes first. This will be assessed through review of participant's medical records.
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Timepoint [4]
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baseline, at 4-6 weeks, at 6 months, then typically 3 monthly follow-ups thereafter (but up to the clinician's decision)
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Secondary outcome [5]
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Referrals to supportive care services
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Assessment method [5]
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will be assessed using the clinician survey and through review of participant's medical records
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Timepoint [5]
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at 6 months (post commencement of 1st line treatment)
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Secondary outcome [6]
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Rate of adverse events that result in first-line treatment dose reduction and/or discontinuation
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Assessment method [6]
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adverse events leading to treatment dose reduction or discontinuation will be assessed through review of participant's medical records
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Timepoint [6]
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at 4-6 weeks, at 6 months, then typically 3 monthly follow-ups thereafter (but up to the clinician's decision)
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Secondary outcome [7]
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Progression free survival
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Assessment method [7]
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Time from commencement of first-line treatment to disease progression or death, whichever comes first. It will be assessed through review of participant's medical records.
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Timepoint [7]
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baseline, at 4-6 weeks, at 6 months, then typically 3 monthly follow-ups thereafter (but up to the clinician's decision)
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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
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Minimum age
70
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
not meeting inclusion criteria
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
3/02/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
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Other Collaborative groups
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Name [1]
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ReVitalise/Regional Trials Network Registry Trials project.
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Address [1]
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Country [1]
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Australia
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Funding source category [2]
317952
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Other Collaborative groups
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Name [2]
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VCCC Alliance: strategies program 4
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Address [2]
317952
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Country [2]
317952
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Australia
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Primary sponsor type
Other
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Name
Walter and Eliza Hall Institute of Medical Research
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
320290
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Country [1]
320290
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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The Royal Melbourne Hospital Human Research Ethics Committee
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Ethics committee address [1]
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https://www.thermh.org.au/research/researchers/ethics
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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30/10/2024
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Approval date [1]
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13/11/2024
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Ethics approval number [1]
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HREC/109499/MH-2024
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Summary
Brief summary
This study aims 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. Who is it for? You may be eligible for this study if you are aged 70 years or over, of any gender and performance status diagnosed with metastatic, or inoperable histologically confirmed HR+, HER2-breast cancer. Decisions about first-line therapy not yet made at this time of consent. Study details Your study doctor will assess whether this research project is appropriate for you. If you are suitable and agree to take part in this research project, you will be asked to sign a consent form. You will undergo a geriatric assessment (questionnaires, quick bedside tests assessing falls risk and cognition) to help your study doctor make decisions about your treatment. You will also complete a survey within 6 weeks of your initial appointment with the doctor about what factors influenced your treatment decisions and how helpful the geriatric assessments were. You will have a follow-up appointment in 4-6 weeks to determine if you stay on the same treatment or if any changes are needed. It is hoped the finding from this study will determine the usefulness of geriatric assessment tools and its impact on clinical decision and patient outcomes.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Vanessa Wong
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Address
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Walter and Eliza Hall Institute/1G Royal Parade, Parkville VIC 3052
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Country
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Australia
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Phone
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+61 3 9345 2555
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Vanessa Wong
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Address
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Walter and Eliza Hall Institute/1G Royal Parade, Parkville VIC 3052
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Country
138459
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Australia
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Phone
138459
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+61 3 9345 2555
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Fax
138459
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Email
138459
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[email protected]
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Contact person for scientific queries
Name
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Vanessa Wong
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Address
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Walter and Eliza Hall Institute/1G Royal Parade, Parkville VIC 3052
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Country
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Australia
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Phone
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+61 3 9345 2555
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Fax
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Email
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[email protected]
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Data sharing statement
Will the study consider sharing 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.
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