Post-treatment Care of Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Change in FACIT-TS questionnaire score
研究概览
简要总结
The overall goal of this proposal is to improve the post-treatment care of breast cancer survivors and to understand the barriers to optimal post-treatment care in Latina and Non-Hispanic women.
详细描述
The proposed investigation is a randomized prospective evaluation of a Survivorship Intervention in improving the quality of care, treatment satisfaction and understanding of care in Latina and Caucasian breast cancer survivors treated in an urban academic medical center. Patients will be recruited within 6 weeks of completing their last definitive breast cancer therapy (radiation or chemotherapy). Patients will complete self administered baseline and follow-up questionnaires. Following baseline evaluation patients will be randomized to receiving either written information for follow-up care of cancer survivors published by the National Cancer Institute (Facing Forward), or the Survivorship Intervention. Patients will not be aware that they are participating in a randomized intervention. After verbally agreeing to participate they will be randomized to group A or B and will receive the corresponding consent. Patients will be re-assessed 3 and 6 months after enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants will be screened for the following inclusion criteria:
- •Age >18 years
- •History of stage 0, I, II, or IIIa breast cancer and no evidence of recurrent disease
- •Within 6 weeks of completion of breast cancer therapy (Surgery, Radiation or Chemotherapy)
- •Caucasian and/or Hispanic (English or Spanish-speaking)
- •Willing to undergo a 1 hr cancer survivorship evaluation
排除标准
- •Patients with the following active conditions or behaviors will be excluded from participation:
- •Evidence of recurrent or metastatic breast cancer
- •Patients who have received surgery only with no adjuvant therapy
- •Uncontrolled or significant psychiatric illness/social situations that would preclude completion of questionnaire or follow-up evaluation.
结局指标
主要结局
Change in FACIT-TS questionnaire score
时间窗: Baseline, 6 months
This is designed to measure change in positive health related behavior.
次要结局
未报告次要终点
研究者
Dawn L. Hershman
Associate Professor of Medicine & Epidemiology
Columbia University