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临床试验/NCT04087057
NCT04087057已完成不适用

Understanding Barriers Associated With Timely Chemotherapy Administration Among Breast Cancer Patients

M.D. Anderson Cancer Center1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2019年8月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
1
主要终点
Assessment of data collected from individual semi-structured interviews

研究概览

简要总结

This trial studies the barriers associated with timely chemotherapy given after surgery (adjuvant) in patients with invasive breast cancer. Meeting with patients and asking questions may help doctors to learn about factors that can cause delays in the start of chemotherapy after surgery in patients with breast cancer.

详细描述

PRIMARY OBJECTIVES:

I. To comprehensively and qualitatively assess and identify the determinants of time to chemotherapy (TTC) delays in a vulnerable population using qualitative methods.

Ia. To describe the health literacy/numeracy, social support and level of trust in physicians of the study participants. (Exploratory)

OUTLINE:

Patients complete questionnaires and participate in an interview to answer questions about the information patients received before starting the chemotherapy, any medical problems after the surgery that could have been related to the start of the chemotherapy, how the chemotherapy affected patients' life, and anything else patients may remember between the time when the breast surgery ended and the first dose of chemotherapy started. Patients' medical records are also reviewed.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Diagnosed with primary invasive breast cancer
  • For patients receiving adjuvant chemotherapy: First dose of chemotherapy administered >= 60 days after definitive breast cancer surgery. For patient treated with neoadjuvant chemotherapy: First dose of chemotherapy administered >= 60 days after pathological diagnosis
  • Diagnosis of breast cancer within three years of study enrollment
  • Can speak, read, and understand English and/or Spanish
  • Patient of Lyndon B. Johnson General Hospital-Harris Health System (LBJ-HHS) or MD Anderson Cancer Center

排除标准

  • Women hospitalized for a critical condition or who are considered medically unstable by their medical team
  • Patients that started chemotherapy >= 3 years after definitive breast cancer surgery

结局指标

主要结局

Assessment of data collected from individual semi-structured interviews

时间窗: Up to 1 year

Will be analyzed using an open code method by identifying and classifying interview data. Qualitative analysis will be done in partnership with a qualitative research consulting group (ResearchTalk, Inc.). Transcripts of the semi-structured interviews will be de-identified by removing 18 protected health information (PHI) identifiers from the transcripts.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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