Status:
ACTIVE_NOT_RECRUITING
Elevate! : An Elderly Breast Cancer Cohort Study
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Susan G. Komen Breast Cancer Foundation
Conditions:
Breast Cancer
Eligibility:
FEMALE
70+ years
Brief Summary
This study is focused on understanding how the investigators can improve upon breast cancer and health outcomes for older participants with breast cancer.
Detailed Description
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 ri...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 19 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2028
Estimated Enrollment :
253 Patients enrolled
Trial Details
Trial ID
NCT03818087
Start Date
February 19 2019
End Date
November 1 2028
Last Update
December 19 2025
Active Locations (4)
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1
Northern Light Cancer Care
Bangor, Maine, United States, 04401
2
Brigham and Women Hospital
Boston, Massachusetts, United States, 02215
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
4
Lifespan Cancer Institute
Providence, Rhode Island, United States, 02903