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Elevate! : An Elderly Breast Cancer Cohort Study

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03818087
Enrollment
253
Registered
2019-01-28
Start date
2019-02-19
Completion date
2028-11-01
Last updated
2025-12-19

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

Conditions

Breast Cancer

Keywords

Breast Cancer

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 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.

Interventions

Patients will be followed by collecting clinical data, biospecimens, and quality of life assessments over a period of five years from registration.

Sponsors

Susan G. Komen Breast Cancer Foundation
CollaboratorOTHER
Dana-Farber Cancer Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

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

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

Design outcomes

Primary

MeasureTime frameDescription
Adjuvant treatment recommendations7 yearsReport treatment recommendations made to patients enrolled on the cohort
Adherence to hormonal therapy7 yearsWe will survey patients on adherence
Barriers to treatment and adherence7 yearsWe will survey patients on the reasons for adherence and poor adherence
Treatment patterns by age and other characteristics7 yearsWe will examine treatment receipt and patterns by subtype of disease

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026