Long Term Follow Up After Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- FACT- Cog
研究概览
简要总结
This trial studies long term follow-up care in patients with stage 0-IIIC breast cancer. Collecting feedback from breast cancer patients may help researchers to define comprehensive long term follow-up care for breast cancer survivors, better understand health-related quality of life and long-term complications in breast cancer survivors, and to increase the knowledge of the mechanisms by which a patient's own immune system attempts to combat breast cancer, and what factors may make this response more successful.
详细描述
PRIMARY OBJECTIVES:
I. To provide comprehensive care to breast cancer survivors diagnosed with stage 0 to IIIC, who received at least part of their treatment at City of Hope.
II. To use the information obtained from follow-up of breast cancer survivors to describe the magnitude of risk and associated risk factors.
III. To use the information gained from follow-up of breast cancer survivors to describe health-related quality of life (HRQL) concerns in breast cancer survivors and identify those at highest risk.
OUTLINE:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of breast cancer, stage 0-IIIC
- •Partial or entire treatment at City of Hope
- •Must be registered before adjuvant therapy and ideally before definitive local therapy
排除标准
- •Stage IV breast cancer
- •Recurrent breast cancer
- •Prior cancers, chemotherapy or radiation * (Note: Subjects who develop locoregional or systemic recurrence while enrolled on this protocol will be withdrawn, and will continue their care with their primary oncology providers only)
结局指标
主要结局
FACT- Cog
时间窗: Change from pre-treatment baseline over a 2-year period
Functional Assessment of Cancer Therapy Cognitive Function
Incidence rates of the study end-points
时间窗: Up to 12 years
Will estimation of incidence rates of the study end-points that may be associated with original diagnosis or treatment received, and delineation of temporal changes in serial measurements and their relationship to time-invariant characteristics such as original diagnosis, race, and education and time varying characteristics such as age and body mass index (BMI). Incidence rates may be compared with national standards adjusted for key demographic variables and between patient subgroups. Time of entry onto the study in the analysis will be from the date of diagnosis of primary disease. Stepwise logistic regression analysis of endpoints of interest at certain follow-up time may be conducted, accounting for the joint effect of such factors as age, time since diagnosis and treatment, radiation dose, chemotherapy and tumor subtype.
Cancer induced immune dysfunction
时间窗: Up to 12 years
Will analyze patients' tumor, lymph node, and blood samples
次要结局
未报告次要终点