Elevate! : An Elderly Breast Cancer Cohort Study



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:70 - Any
Updated:3/15/2019
Start Date:February 19, 2019
End Date:November 1, 2028
Contact:Rachel A. Freedman, MD, MPH
Email:rafreedman@partners.org
Phone:617-632-3800

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Elevate! : Improving Outcomes for Older Patients With Breast Cancer:a Longitudinal Cohort and Patient Engagement Study

This study is focused on understanding how the investigators can improve upon breast cancer
and health outcomes for older participants with breast cancer.

This study is focused on understanding how the investigators can improve upon breast cancer
and health outcomes for older participants with breast cancer, a group of participants who
often have low risk cancers, but who may do worse than younger participants with the same
kind of cancers. Researchers want to better understand the experiences, barriers, and changes
in physical function older participants with breast cancer have.

Inclusion Criteria:

- Age 70 or older at the time of diagnosis (as indicated by the date of breast biopsy)

- No more than 67 patients (1/3) will be aged 70-74, with the remaining patients on
study ages 75 or older

- Any gender is eligible

- Invasive, non-metastatic breast cancer at diagnosis

- Those with prior diagnoses of pre-invasive (DCIS) or invasive breast cancer are
eligible as long as their current diagnosis is felt by the treating provider to
represent a NEW non-metastatic primary invasive breast cancer (e.g. someone with a
nodal recurrence from prior disease are not eligible but those with a new
contralateral breast cancer 3 years after a first breast cancer would be eligible)

- Any breast cancer subtype is allowed

- Breast cancer-diagnosing biopsy within 90 days of enrollment

- Receiving or will receive medical oncology care (+/- surgical and radiation oncology
treatments) at the participating center: DFCI/satellites and affiliate sites

- Patients must be able to understand, speak, and read English or assign a designated
caregiver/proxy for the duration of the study who understands, speaks, and reads
English and who is willing to assist with filling out the survey components which do
not have a validated, translated version. This is because the surveys are not readily
available in multiple languages as a whole, although some components (such as the
Geriatric Assessment and PROs are readily available in multiple languages).

- If a patient scores 11 or higher on the baseline Orientation-Memory-Concentration Test
done at baseline (Appendix E), a proxy/designee must then be assigned to help the
patient fill out the questionnaires for the duration of the study in order to
participate. The treating provider will also be notified about the cognitive
impairment.

- Ability to provide informed consent

Exclusion Criteria:

- Pathological or clinical stage 0, IV disease

- Those with nodal or metastatic recurrences at the time of enrollment

- Unable to speak and read English AND no designee who speaks and reads English, as
above

- Unable to provide informed consent
We found this trial at
2
sites
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Rachel A Freedman, MD, MPH
Phone: 617-632-3800
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, Massachusetts 02215
Principal Investigator: Freedman Rachel, MD
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