GENetic Education Risk Assessment and TEsting Study (GENERATE)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Change of genetic testing among family members of mutation positive PDAC patients, among family members of mutation positive individuals with a family history of PDAC and among first-degree relatives of PDAC patients
研究概览
简要总结
The goal of the GENERATE Study is to improve genetic testing and cancer prevention in family members of pancreatic cancer patients who may have genetic mutations (inherited changes). The study will measure how different methods of genetic education increase the rate of genetic testing in these families.
This is an investigational study to measure the effects of two methods of genetic education. Participants may elect to undergo genetic testing as part of the study and will be asked to provide a saliva sample via a saliva-testing kit. The genetic testing done in this study is FDA approved and will be processed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory.
Up to 1,000 participants will be enrolled in this study.
详细描述
Around 1 in 10 (10%) pancreatic cancer patients carries an inherited change (mutation) in a gene which can increase the risk of cancer. Relatives of patients with pancreatic cancer are often unaware that the mutation can be passed down through the family. Having information about genetic risk can be important to family members. There may be options for early and/or more frequent screening (to look for cancer or pre-cancer) or early detection recommendations.
This research is being done to study the impact of different methods of teaching about and offering genetic testing to family members of pancreatic cancer patients who may carry a mutation.
Study arms:
Individuals will be randomized (like flipping a coin) by family to one of the two study arms to receive genetic education and elect to undergo genetic testing.
Individuals in Arm 1 (video conference platform plus Color Genomics) will receive genetic education via a pre-recorded educational video and interactive session with the study team through an internet-based platform.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Individual who is 18 years or older
- •Individual who has signed the informed consent
- •Individual with:
- •-A first-degree relative who has (or had) pancreatic ductal adenocarcinoma (PDAC) OR a second-degree relative who has (or had) PDAC and has a known germline mutation in APC, ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2, PMS2, STK11, or TP53
- •The germline mutation and history of PDAC must be on the maternal side or paternal side of the individual's family
- •Individual with a valid United States mailing address
- •Individual with access to a healthcare provider and is willing to share genetic test results with that provider/the study team
排除标准
- •Individual with a known cancer susceptibility gene
- •Individual who has received genetic counseling for cancer risk within the last 3 years
- •Individual who has received a bone marrow transplant, who has had a blood transfusion within the last 7 days, or who has an active hematologic malignancy (i.e. leukemia or lymphoma)
- •Individual who is unable to sign the informed consent because of mental incompetency or psychiatric illness
- •Individual who is unwilling to complete baseline and follow-up questionnaires
- •Individual who has a life expectancy of less than 1 year
- •Individual with only APC I1307K mutation within their family
- •Individual with only PMS2 exons 12-15 deletion mutation within their family
研究组 & 干预措施
Doxy.me plus Color Genomics Arm (Arm 1)
- Participants in this arm will receive genetic education through an online platform called Doxy.me
- The Doxy.me session will consist of two parts: 1) a pre-recorded genetic education video 2) a live interactive video conferencing session with a GENERATE genetic counselor
- After completing the Doxy.me session and post intervention questionnaires, participants will be directed to the Color Genomics study portal where they may elect to review Color Genomics' genetic education content or proceed directly to order genetic testing
- Intervention is Doxy.me genetic education +/- genetic education via Color Genomics website
干预措施: Doxy.me genetic education +/- Color Genomics genetic education (Other)
Color Genomics Only Arm (Arm 2)
- Participants in this arm will access genetic education on the Color Genomics website which includes both written information and an educational video
- After accessing the Color Genomics website, participants may elect to review educational content or proceed directly to order genetic testing
- Intervention is genetic education via Color Genomics website
干预措施: Color Genomics genetic education (Other)
结局指标
主要结局
Change of genetic testing among family members of mutation positive PDAC patients, among family members of mutation positive individuals with a family history of PDAC and among first-degree relatives of PDAC patients
时间窗: 2 years
Measure the effect that alternative methods of genetic education and delivery models have on the increase of genetic testing among family members of mutation positive PDAC patients, among family members of mutation positive individuals with a family history of PDAC and among first-degree relatives of PDAC patients in each arm of the intervention study. We will document how many relatives per family elect to undergo genetic testing and compare the results of this measure between both arms of the study.
次要结局
- Increase of knowledge of genetic testing(Immediately post intervention)
- Level of cancer-risk distress(Baseline, immediately post intervention, 3-4 months post intervention, 15 months post intervention)
- Factors in decision making(Immediately post intervention)
- Degree of family communication about genetic test results(3-4 months post intervention, 15 months post intervention)
- Uptake of surveillance for pancreatic, other associated cancers and health behaviors(Baseline and 15 months post intervention)
研究者
Sapna Syngal, MD, MPH
Principal Investigator
Dana-Farber Cancer Institute