Trial of Strategies to Communicate Genetic Information to Different Ethnic and Racial Subpopulations
试验速览
- 阶段
- 不适用
- 入组人数
- 597
- 试验地点
- 1
- 主要终点
- Composite outcome measure using health decisions and healthcare utilization
研究概览
简要总结
The goal of this study is to better understand how clinicians give genetic risk information to patients from multi-ethnic groups and how patients understand this information and remember it and act upon it. In addition investigators want to know how to better communicate with patients about complex health issues across the health literacy divide and communication gap that exists between doctors and their patients.
详细描述
Any patient referred to the breast cancer and genetic risk counseling clinics in either of the two sites will be eligible to participate as long as they meet the inclusion and exclusion criteria. The research assistant in each site will meet with the patients and explain about the study goals and procedures and ask them to participate in the study. Those interested will be enrolled into the study after obtaining informed consent. For those who refuse to participate, reasons for refusal will be requested and catalogued. All study participants will be followed and the study measures will be tracked at Days 0, 30, 180 and 365. In addition, health care utilization (ER Visits, Hospitalizations, clinic visits, screening tests and procedures) will be tracked both through the electronic medical records and patient interviews (as some patients may seek care in other hospitals for emergencies etc.). Investigators currently do follow-up phone interviews routinely with our patients. Study measures will be administered as described above. For those who drop out from the study, reasons for withdrawal from the study will be explored and catalogued.
Procedures for Treatment Compliance and Treatment Non-completers:
(i) Compliance Procedures: Investigators will monitor degree of compliance with whether study measures were completed on Days 0,7,30 & 365 intervention. Analyses will be done following the intent-to-treat principle.
(ii) Treatment Non-completers: For those who drop out from the study after Day 0, reasons for withdrawal from the study will be explored and catalogued. They will be asked for feedback about the study intervention and satisfaction with the experience (or the lack thereof).
Procedures for Data Collection: The participants will have the option of submitting the data in person or by phone to the project research associate. The PI will meet with the study personnel at least on a weekly basis to continuously monitor their performance and to ensure adherence to study methodology.
研究设计
- 研究类型
- Observational
- 观察模型
- Family Based
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cancer Patients
- •Over 18 years of age.
排除标准
- •Healthy Volunteers.
结局指标
主要结局
Composite outcome measure using health decisions and healthcare utilization
时间窗: up to 3 years
In this observational study, investigators propose to follow patients for a period of one to three years to track their cancer treatment and screening decisions (e.g. if they complete mammograms, MRI, surgery, chemotherapy, radiation therapy) as recommended by the clinical team and also ER visits, hospitalizations, ICU admissions and death.
次要结局
未报告次要终点
研究者
VJ Periyakoil
Clinical Associate Professor
Stanford University