Implementation of the Families Accelerating Cascade Testing Toolkit (FACTT) for Hereditary Breast and Ovarian Cancer and Lynch Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Proband-reported cascade testing rates of first-degree relatives
研究概览
简要总结
The purpose of this research study is to learn how cancer care providers can help their patients communicate the need for genetic testing in families with inherited cancer syndromes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None
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
- •Documentation of HBOC or Lynch-associated "pathogenic/ likely pathogenic" mutation per American College of Medical Genetics and Genomics criteria (1)
- •Diagnosis of one or more invasive cancers: epithelial ovarian, fallopian tube, primary peritoneal, breast, colorectal, endometrial
- •Mutation listed in NCCN guidelines with at least Category 2A evidence for intervention
- •Over the age of 18
- •Psychological ability and general health that permits completion of study requirements and follow-up
- •Willingness to complete follow-up surveys in person, electronically, or by telephone for up to 6 months
排除标准
- •"Variant of undetermined significance," "likely benign" or "benign" variant per ACMGG criteria
研究组 & 干预措施
Usual Care
- For approximately the first 6 months of the study, or until 75 patient with cancer who is initially approached in clinic (probands) are enrolled, the investigators will be enrolling probands into the "Usual Care" group. During this time, the investigators will clarify usual care regarding cascade genetic testing for each participating clinic and proband participant. The investigators will do this by proband participant surveys, as well as initial provider semi-structured interviews.
- Proband: Complete Cascade Genetic Testing survey. The survey will also contain questions regarding willingness or not to invite each eligible 1st degree family member to participate in the family study. At 6 months, there will be a follow-up survey
- Family Member: Complete survey at study entry and at 6 month follow-up
FACT Toolkit (FACTT)
- Proband: Introduced to FACTT and will complete Cascade Genetic Testing survey. The survey will contain questions regarding willingness or not to invite each eligible 1st degree family member to participate in the family study. The probands will also fill out assessments of each FACTT component. At 6 months, there will be a follow-up survey.
- Family Member: Introduced to FACTT and will complete surveys at study entry and 6 month follow-up. They will also fill out assessments of each FACTT component
干预措施: Families Accelerating Cascade Testing Toolkit (Other)
结局指标
主要结局
Proband-reported cascade testing rates of first-degree relatives
时间窗: From start of study through completion of 6 month follow-up (estimated to be 18 months)
-For each proband, this testing rate is defined as the number of first-degree relatives tested divided by the number of living first-degree relatives age-appropriate for testing, as determined by family surveys done by the proband. The investigators will calculate mean cascade genetic testing rates for both conditions (Usual Care and FACTT intervention).
Family member-reported cascade testing rates
时间窗: From start of study through completion of 6 month follow-up (estimated to be 18 months)
-This testing rate is defined by the number of family members tested divided by the number of living family members age-appropriate for testing
Number of primary barriers to genetic testing for family members
时间窗: From start of study through completion of 6 month follow-up (estimated to be 18 months)
-The Family Member survey will assess experience with considering testing themselves, decisional regret regarding genetic testing, and if they have tested positive
Number of primary barriers to genetic testing for first-degree relatives
时间窗: From start of study through completion of 6 month follow-up (estimated to be 18 months)
-The Cascade Genetic Testing survey will assess knowledge, perception, and personal experience with sharing germline mutation information with first-degree relatives
次要结局
未报告次要终点