Elevate! : An Elderly Breast Cancer Cohort Study

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03818087
• Other study ID #: 18-634
• Status: Recruiting
• Start date: February 19, 2019
• Est. completion date: November 1, 2028

Study information

• Verified date: June 2023
• Source: Dana-Farber Cancer Institute
• Contact: Rachel A. Freedman, MD, MPH
• Phone: 617-632-3800
• Email: rafreedman[@]partners.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: November 1, 2028
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Northern Light Cancer Care	Bangor	Maine
United States	Brigham and Women Hospital	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Lifespan Cancer Institute	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Susan G. Komen Breast Cancer Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adjuvant treatment recommendations	Report treatment recommendations made to patients enrolled on the cohort	7 years
Primary	Adherence to hormonal therapy	We will survey patients on adherence	7 years
Primary	Barriers to treatment and adherence	We will survey patients on the reasons for adherence and poor adherence	7 years
Primary	Treatment patterns by age and other characteristics	We will examine treatment receipt and patterns by subtype of disease	7 years