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BOLDER: Breast cancer decision making and outcomes in OLDER Australians

BOLDER: Breast cancer decision making and outcomes in OLDER Australians

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12624001494527
Enrollment
30
Registered
2024-12-20
Start date
2025-02-03
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 abou

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.

Sponsors

Walter and Eliza Hall Institute of Medical Research
Lead SponsorOther

Eligibility

Sex/Gender
All
Age
70 Years to No maximum
Healthy volunteers
No

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

Exclusion criteria

not meeting inclusion criteria

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026