NCT04330716已完成不适用
Genetic Testing for Breast, Ovarian, Pancreatic, and Prostate Cancers - GeneBOPP
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 269
- 试验地点
- 12
- 主要终点
- Rate of patients who have germline genetic tests
研究概览
简要总结
This study is evaluating the effect of two pre-test education methods on participants interested in genetic testing for hereditary cancer risk.
详细描述
This prospective, randomized controlled trial will evaluate the effect of two pre-test education methods on the level of participation in genetic testing for hereditary cancer risk. A prospective study examines outcomes before the development of a disease.
- The research study procedures include screening for eligibility, randomization and a series of questionnaires.
- Participants will be randomized, or assigned by chance, to one of two methods of pre-genetic test education and after completing either pre-test education participants will be offered the opportunity to have genetic testing performed
Two methods of pre-genetic test education:
- video education
- in-person counseling
- Genetic testing will be performed by blood draw.
- It is expected that 500 people will participate in this study
- Participants will be in the research study for up to 5 yrs after enrollment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •Potentially eligible participants will be identified via medical record screening and/or in accordance with their clinical visit. A HIPAA waiver of authorization will be obtained by the enrolling Institution as needed to have access to the subject's medical record information for screening of eligibility.
- •A member of the study team will approach the potentially eligible participant in clinic and discuss the trial. Potentially eligible participants may choose to discuss participation further with their physician at their appointment
- •Age ≥ 18 years
- •Breast, ovarian, pancreatic, or metastatic prostate cancer
- •No prior cancer genetic testing
- •Ability to understand and the willingness to sign an informed consent document
排除标准
- •Prisoners
- •Inability to understand English as a spoken language in a healthcare context
- •Known hematologic malignancy (e.g. CLL)
结局指标
主要结局
Rate of patients who have germline genetic tests
时间窗: Up to 3 years
Measurement of genetic testing uptake in breast, ovarian, pancreatic, and prostate cancer patients randomized to pre-genetic test (pre-test) in-person counseling with a genetic counselor per standard of care or video education.This comparison will use a two-sided Fisher exact test
次要结局
- Patient Satisfaction Survey following intervention(Immediately following intervention)
- Cascade testing in positives(after results have been received, four months post-intervention)
- Decisional Regret(after results have been received, two months post-intervention)
- Result Disclosure Preference following intervention(Immediately following intervention)
- Knowledge about genetics testing(Immediately following intervention)
- Patient Satisfaction 2 months following intervention(after results have been received, two months post-intervention)
- Psychological distress following intervention(after results have been received, two months post-intervention)
- Family communication of genetic test results(after results have been received, two months post-intervention)
- Positive Results impact(after results have been received, four months post-intervention)
研究者
Huma Rana, MD
Principal Investigator
Dana-Farber Cancer Institute
研究点 (12)
Loading locations...
相似试验
已完成
不适用
Counseling Interventions for BRCA 1/2 Cancer Susceptibility TestingBreast CancerOvarian CancerNCT00165152Dana-Farber Cancer Institute150
已完成
不适用
Genetic Counseling Processes and Outcomes Among Males With Prostate Cancer (ProGen)Prostate CancerNCT03328091Dana-Farber Cancer Institute662
已完成
不适用
Michigan Genetic Hereditary Testing (MiGHT)Endometrial CancerHistory of CancerBreast CancerPancreatic CancerProstate CancerColorectal CancerOvarian CancerNCT05162846University of Michigan Rogel Cancer Center793
已完成
不适用
OPTimizing Treatment Focused Genetic Testing IN CancerBreast CancerProstate CancerPancreatic CancerOvarian CancerNCT04066361Dana-Farber Cancer Institute301
已完成
不适用
Awareness and Attitudes Regarding Prenatal and Preimplantation Genetic Diagnosis for Inherited Breast/Ovarian Cancer RiskBreast CancerOvarian CancerNCT00735150Memorial Sloan Kettering Cancer Center34