The Genetic Information and Family Testing (GIFT) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,002
- 试验地点
- 4
- 主要终点
- To determine the independent effects of the two virtual platform design features on relatives' receipt of genetic testing.
研究概览
简要总结
The Genetic Information and Family Testing (GIFT) Study is designed to support the capacity, opportunity, and motivation of cancer patients to engage their relatives about inherited cancer susceptibility and provide support and services to those relatives to initiate GRE (including genetic testing) and prepare them to subsequently engage their clinicians in informed decision-making about cancer prevention and early detection.
详细描述
GIFT features a web-based intervention that offers access to an online family communication program containing key facts about genetics, cancer risk, and the role of genetic testing and helps patients share health information with their first-and second-degree relatives, whom they can invite to join the study to receive education/support and access to low-cost genetic testing. Two design features of the intervention will be randomized and evaluated to determine the best approach for future scalability.
Those eligible will be offered enrollment into the Michigan-hosted intervention trial, and those who enroll will be randomized into 1 of 4 study arms. Patients can invite their relatives to enroll and receive genetic testing via Color. Families randomized to the arms with human Navigator support will also have access to a Family Health Navigator at Stanford University. Enrolled patients and relatives will be surveyed six months post-enrollment to collect additional information regarding their interactions with the GIFT platform and their experiences with genetic risk evaluation.
Study phase and approximate sample size is summarized below:
- Initial patient sample selected- 5250 patients
- Respondents to PICS survey- 3150 patients
- Pool of patients eligible for GIFT study invitation- 2930 patients
- Patient GIFT study participants- 880 patients
- Relatives invited to the GIFT study- 3520 relatives
- Relative GIFT study participants- 1584 relatives
Study phase and approximate sample size summarizes have been updated below and IRB approved 29SEP2025:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Randomization will be concealed from study participants; enrolled patients and relatives will not be aware that their family has been randomized into one of four trial arms and provided a different intervention experience than the other study participants. Concealment is necessary for this study so that the trial can observe differences across the trial arms without a) negatively impacting study enrollment and biasing the study, and b) causing unnecessary negative emotional reactions in study participants.
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
- •for the PICS survey are:
- •diagnosed with any cancer at any stage in 2018-2019 and reported to the Georgia or California SEER registries
- •Been found to carry a pathogenic variant (PV) in one of 27 cancer susceptibility genes (see Table 4) according to the Georgia California Genetic Testing Linkage Initiative dataset
- •aged 18 or older
- •alive at the time of selection as determined through linkage with Georgia and California vital statistics data.
- •Additional eligibility criteria for Patient Trial Invitation will be evaluated from patient response to the PICS survey and will include patient report of:
- •Receipt of genetic testing for cancer risk
- •A positive test result (pathogenic variant; PV)
- •Inclusion criteria for Relative Trial Invitation are assessed via patient report:
- •first-degree (biological parent, sibling, or biological child) or second-degree (biological half-sibling, aunt, uncle, nephew, niece, grandparent, or grandchild) relative of a patient enrolled in the study;
- •aged 18 or older;
- •alive at the time of study invitation;
- •relative lives in the United States or Canada (countries in which Color genetic testing is available, most people speak either English or Spanish, and test kit shipping costs are not exorbitant)
- •Additional eligibility criteria for Relative Trial Enrollment will be evaluated from relative response to the relative eligibility screening survey (see Appendix C) and will include:
- •confirmation from the relative that they have not received clinical genetic testing ordered by a doctor or genetic counselor within the past five years (proxy for having already been tested for the PV carried by the patient who invited them into the study);
- •confirmation of age 18 or older;
- •confirmation of first-degree (biological parent, sibling, or biological child) or second-degree (biological half-sibling, aunt, uncle, nephew, niece, grandparent, or grandchild) relation to the patient.
- •confirmation of residence in United States or Canada
排除标准
- •Exclusion criteria for the PICS survey are:
- •1) Age<18
- •Additional exclusion criteria for Patient Trial Invitation:
- •Patients who do not report receipt of genetic testing
- •Patients who do not report a positive genetic test result (PV)
- •Exclusion criteria for Relative Trial Invitation are:
- •Relative does not live in the United States or Canada
- •Additional exclusion criteria for Relative Trial Enrollment include relative report of:
- •Receipt of genetic testing ordered by a doctor or genetic counselor within the past five years;
- •Relationship to proband (inviting) patient other than first- or second-degree relative
- •Residence in a country other than United States or Canada
研究组 & 干预措施
Arm 1
Arm information details will not be provided at this time in order to preserve scientific integrity and will be updated once the study has resulted.
干预措施: GIFT (Genetic)
Arm 2
Arm information details will not be provided at this time in order to preserve scientific integrity and will be updated once the study has resulted.
干预措施: GIFT (Genetic)
Arm 3
Arm information details will not be provided at this time in order to preserve scientific integrity and will be updated once the study has resulted.
干预措施: GIFT (Genetic)
Arm 4
Arm information details will not be provided at this time in order to preserve scientific integrity and will be updated once the study has resulted.
干预措施: GIFT (Genetic)
结局指标
主要结局
To determine the independent effects of the two virtual platform design features on relatives' receipt of genetic testing.
时间窗: 6 months after the final relative enrolls
The proportion of each enrolled patient's 1st and 2nd degree relatives who receive Color genetic testing through the GIFT platform. For each enrolled patient, this will be calculated as the number of enrolled relatives who obtain a genetic test result from Color (complete the genetic testing process) via the GIFT Study divided by the number of relatives reported on the baseline PICS survey. The endpoint of interest is the presence (as opposed to the absence) of a test result (e.g., positive, uncertain, negative) on the Color Quarterly Report. Assessed six months after the final relative enrolls in the study.
次要结局
- To determine the independent effects of the two virtual platform design features on relatives' receipt of a formal cancer genetic counseling session in practice.(After the 6 month follow up survey)
- To determine the independent effects of the two virtual platform design features on the proportion of relatives invited by each patient to enroll in the study.(91 days after the final patient enrolls)
- To determine the independent effects of the two virtual platform design features on the cancer patients' assessment of communication with their relatives about hereditary cancer and genetic risk evaluation.(After the 6 month follow up survey)