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Clinical Trials/NCT03818087
NCT03818087
Active, not recruiting
Not Applicable

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

Dana-Farber Cancer Institute4 sites in 1 country253 target enrollmentFebruary 19, 2019
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Dana-Farber Cancer Institute
Enrollment
253
Locations
4
Primary Endpoint
Treatment patterns by age and other characteristics
Status
Active, not recruiting
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 19, 2019
End Date
November 1, 2028
Last Updated
4 months ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rachel Freedman, MD, MPH

Primary Investigator

Dana-Farber Cancer Institute

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.

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

Outcomes

Primary Outcomes

Treatment patterns by age and other characteristics

Time Frame: 7 years

We will examine treatment receipt and patterns by subtype of disease

Adjuvant treatment recommendations

Time Frame: 7 years

Report treatment recommendations made to patients enrolled on the cohort

Adherence to hormonal therapy

Time Frame: 7 years

We will survey patients on adherence

Barriers to treatment and adherence

Time Frame: 7 years

We will survey patients on the reasons for adherence and poor adherence

Study Sites (4)

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