Elevate! : An Elderly Breast Cancer Cohort Study

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

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

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Observational cohort

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.

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Rachel A. Freedman, MD, MPH; Phone Number: 617-632-3800; Email: rafreedman@partners.org

Study Locations

• United States
  • Maine
    • Bangor, Maine, United States, 04401
      • Recruiting
      • Northern Light Cancer Care
      • Contact: Sarah Sinclair, DO
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana-Farber Cancer Institute
      • Contact: Rachel A Freedman, MD, MPH; Phone Number: 617-632-3800; Email: rafreedman@partners.org
      • Principal Investigator: Rachel A Freedman, MD, MPH
    • Boston, Massachusetts, United States, 02215
      • Active, not recruiting
      • Brigham and Women Hospital
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Recruiting
      • Lifespan Cancer Institute
      • Contact: Mary Anne Fenton, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Age 70 or older at the time of diagnosis

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Elevate; Participants over the age of 70 years old with early-stage breast cancer will be recruited.	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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: Susan G. Komen Breast Cancer Foundation
• Investigators: Principal Investigator: Rachel A Freedman, MD, MPH, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2019
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: December 19, 2018
• First Submitted That Met QC Criteria: January 23, 2019
• First Posted (Actual): January 28, 2019

Study Record Updates

• Last Update Posted (Actual): June 6, 2023
• Last Update Submitted That Met QC Criteria: June 5, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Breast Cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 18-634

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor- Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication.
• IPD Sharing Access Criteria: Requests may be directed to: [contact information for Sponsor- Investigator or designee].
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No