Breast Cancer Clinical Trial

Elevate! : An Elderly Breast Cancer Cohort Study

Summary

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

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Full 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 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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Breast Cancer

Estimated Enrollment:

250

Study ID:

NCT03818087

Recruitment Status:

Recruiting

Sponsor:

Dana-Farber Cancer Institute

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There are 3 Locations for this study

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Northern Light Cancer Care
Bangor Maine, 04401, United States More Info
Sarah Sinclair, DO
Contact
Brigham and Women Hospital
Boston Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States More Info
Rachel A Freedman, MD, MPH
Contact
617-632-3800
[email protected]
Rachel A Freedman, MD, MPH
Principal Investigator
Lifespan Cancer Institute
Providence Rhode Island, 02903, United States More Info
Mary Anne Fenton, MD
Contact

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

250

Study ID:

NCT03818087

Recruitment Status:

Recruiting

Sponsor:


Dana-Farber Cancer Institute

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