The Patient-Driven Self-Navigated Web-Based Family Outreach Program for Cancer Prevention in High-Risk Families
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Web-Based Family Outreach Registry
研究概览
简要总结
This trial develops a patient-driven self-navigated web-based family outreach program for cancer prevention in high-risk families. Creating the family outreach program may help to improve the way in which genetic test results are communicated within families and increase the number of at-risk relatives who become aware of their risks.
详细描述
PRIMARY OBJECTIVES:
I. To develop a secure, web-based program for family outreach in Clinical Cancer Genetics (CCG).
II. The long-term goals of this program are expected to include, but are not limited to the following:
IIa. To enable families with inherited cancer susceptibility and/or at increased familial risk of cancer to provide personal and family history of neoplasia through a convenient and self-directed program.
IIb. To enable communication of possible inherited cancer susceptibility with and among family members through the web-based portal.
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
- 是
入选标准
- •Individuals who have been diagnosed with a hereditary cancer-causing mutation. Individuals may be identified through clinical testing as patients at MD Anderson or patients whose mutation was identified at an outside institution who contact the registry
- •Individuals that have clinical suspicion for syndromic cancer susceptibility, but in whom mutational testing has been nondiagnostic (depending on condition in question, nondiagnostic testing may be as little as 10%, as in familial adenomatous polyposis [FAP], or as high as 70% in suspected hereditary diffuse gastric cancer or HDGC)
- •At-risk family members of individuals with a cancer causing mutation or of individuals with nondiagnostic testing notwithstanding presence of likely syndromic cancer. Such patients will in most cases not be MD Anderson patients. Note: The enrollment, consenting, and evaluation process anticipates and addresses this.
排除标准
- •Index patients who test negative for a cancer causing mutation, except for those agreeing to provide family history (FH) that is informative for at-risk individuals when no other source of such information is available
- •Patients who are unwilling or are unable to provide informed consent
研究组 & 干预措施
Observational (family outreach program)
Patients communicate with at-risk family members to share genetic test results and other relevant information, as well as to learn more about their disease via family outreach program website. At risk family members are then contacted by a study coordinator or genetic counselor for further follow up. At-risk relatives receive resources to facilitate understanding of their at-risk status and to facilitate predictive testing.
干预措施: Questionnaire Administration (Other)
Observational (family outreach program)
Patients communicate with at-risk family members to share genetic test results and other relevant information, as well as to learn more about their disease via family outreach program website. At risk family members are then contacted by a study coordinator or genetic counselor for further follow up. At-risk relatives receive resources to facilitate understanding of their at-risk status and to facilitate predictive testing.
干预措施: Web Site (Behavioral)
结局指标
主要结局
Web-Based Family Outreach Registry
时间窗: Continual assessment of data over participant's life time (target follow-up duration: 40 Years)
Data analysis for core functions of the web-based Family Outreach Registry will generally be descriptive. Web-based program to improve the way in which genetic test results are communicated within families and to increase the number of at-risk relatives who become aware of their risks.
次要结局
未报告次要终点