Elevate! : Improving Outcomes for Older Patients With Breast Cancer:a Longitudinal Cohort and Patient Engagement Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 253
- 试验地点
- 4
- 主要终点
- Treatment patterns by age and other characteristics
研究概览
简要总结
This study is focused on understanding how the investigators can improve upon breast cancer and health outcomes for older participants with breast cancer.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Treatment patterns by age and other characteristics
时间窗: 7 years
We will examine treatment receipt and patterns by subtype of disease
Adjuvant treatment recommendations
时间窗: 7 years
Report treatment recommendations made to patients enrolled on the cohort
Adherence to hormonal therapy
时间窗: 7 years
We will survey patients on adherence
Barriers to treatment and adherence
时间窗: 7 years
We will survey patients on the reasons for adherence and poor adherence
次要结局
未报告次要终点
研究者
Rachel Freedman, MD, MPH
Primary Investigator
Dana-Farber Cancer Institute