Elevate! : An Elderly Breast Cancer Cohort Study

• Sponsor: Dana-Farber Cancer Institute (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03818087
• Collaborator: Susan G. Komen Breast Cancer Foundation (Other)
• Enrollment: 250
• Locations: 4
• Anticipated Duration (Months): 116.4
• Patients Per Site: 62.5
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	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 Design

• Study Type: Observational
• Anticipated Enrollment: 250 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Elevate! : Improving Outcomes for Older Patients With Breast Cancer:a Longitudinal Cohort and Patient Engagement Study
• Actual Study Start Date: Feb 19, 2019
• Anticipated Primary Completion Date: Nov 1, 2025
• Anticipated Study Completion Date: Nov 1, 2028

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Adjuvant treatment recommendations [7 years]

   Report treatment recommendations made to patients enrolled on the cohort

2. Adherence to hormonal therapy [7 years]

   We will survey patients on adherence

3. Barriers to treatment and adherence [7 years]

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

4. Treatment patterns by age and other characteristics [7 years]

   We will examine treatment receipt and patterns by subtype of disease

Eligibility Criteria

Criteria

• Ages Eligible for Study: 70 Years and Older
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northern Light Cancer Care	Bangor	Maine	United States	04401
2	Brigham and Women Hospital	Boston	Massachusetts	United States	02215
3	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02215
4	Lifespan Cancer Institute	Providence	Rhode Island	United States	02903

Sponsors and Collaborators

• Dana-Farber Cancer Institute
• Susan G. Komen Breast Cancer Foundation

Investigators

• Principal Investigator: Rachel A Freedman, MD, MPH, Dana-Farber Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rachel Freedman, MD, MPH, Primary Investigator, Dana-Farber Cancer Institute
• ClinicalTrials.gov Identifier: NCT03818087
• Other Study ID Numbers: 18-634
• First Posted: Jan 28, 2019
• Last Update Posted: May 26, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Rachel Freedman, MD, MPH, Primary Investigator, Dana-Farber Cancer Institute: Breast Cancer
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of May 26, 2022