Clinical trial NCT03818087: Elevate! : An Elderly Breast Cancer Cohort Study
Official title: Elevate! : Improving Outcomes for Older Patients With Breast Cancer:a Longitudinal Cohort and Patient Engagement Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Keywords: Breast Cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Susan G. Komen Breast Cancer Foundation
First posted: 2019-01-28
Enrollment: 253
Sex: FEMALE
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Age 70 or older at the time of diagnosis

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.

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.
* 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

Primary outcomes:
measure: Adjuvant treatment recommendations
timeFrame: 7 years
measure: Adherence to hormonal therapy
timeFrame: 7 years
measure: Barriers to treatment and adherence
timeFrame: 7 years
measure: Treatment patterns by age and other characteristics
timeFrame: 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bangor
country: United States
facility: Northern Light Cancer Care
state: Maine
city: Boston
country: United States
facility: Brigham and Women Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Providence
country: United States
facility: Lifespan Cancer Institute
state: Rhode Island
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Rachel A Freedman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: