Feasibility Study: IGNITE-TX (Identifying Individuals for Genetic Testing & Treatment) Intervention
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 205
- 试验地点
- 1
- 主要终点
- Measure response rate to baseline and follow-up surveys by probands and at-risk relatives
研究概览
简要总结
This is a community-based study requiring participant-self-enrollment, that can help to increase the rates of genetic testing among the family members of people who have been diagnosed with a hereditary cancer syndrome. The two main factors in this study are the IGNITE-TX intervention (website and navigator) and the free genetic counseling and testing.
The IGNITE-TX Intervention is an innovative multi-modal intervention, with two components: a) interactive web "IGNITE-TX Hub" and b) genetic family navigators.
详细描述
Primary Objectives:
The primary objectives of this study are to assess the study feasibility by estimating:
- The enrollment of probands and (ARRs) at-risk relatives over a 6-month period
- The response rate to baseline and follow-up surveys by probands
- The response rate to baseline and follow-up surveys by (ARRs) at-risk relatives
Secondary Objectives:
The secondary objectives of this study are to:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •Inclusion Criteria:
- •18 years of age or older
- •Speaks and/or reads English or Spanish
- •Has known deleterious/pathogenic mutation or suspected deleterious/pathogenic variant in BRCA1 or BRCA2 (HBOC) or MLH1, MSH2, MSH6, PMS2, or EPCAM (LS)
- •Has access to the internet or phone and can send and receive email and/or text messages at a US telephone number
- •Has at least one at-risk relative who meets inclusion criteria for first-degree relative
排除标准
- •Has no at-risk relatives meeting inclusion criteria
- •Has negative germline genetic testing or only variant of uncertain significance
- •Unwilling or unable to provide consent 4.
- •AT-RISK RELATIVES (ARR)
- •Inclusion Criteria:
- •18 years of age or older
- •Speaks and reads English or Spanish
- •Resides in the United States
- •Can provide proof of deleterious/suspected deleterious HBOC or LS variant present in a first degree relative (biological mother or father, biological child, or full sibling)
- •Has access to internet or phone and can send and receive email and/or text messages at a US telephone number
- •Exclusion Criteria:
- •Unwilling or unable to provide consent
- •Reports no known HBOC or LS variant within the family
- •Has already been tested for the variant identified in the proband
- •Already listed as an ARR for another proband
研究组 & 干预措施
Group 1 (Standard of Care Group)
Participants (probands, those with a hereditary cancer syndrome) are sent a family letter to share with relatives. The letter contains information about hereditary cancer syndromes and encourages relatives to participate in the study and to get genetic testing.
Relatives of probands randomized to the usual care arm will have access to the family letter if probands decide to share it with them, and will receive study surveys. The letter contains information about hereditary cancer syndromes and encourages relatives to participate in the study and to get genetic testing
Group 2 (Free genetic testing and counseling group)
Enrolled relatives will receive a letter and baseline survey with information to contact the tele-genetics company to arrange free genetic counseling and testing. This letter will be given to the relatives directly by the study
干预措施: Free genetic testing and counseling group (Behavioral)
Group 2 (Free genetic testing and counseling group)
Enrolled relatives will receive a letter and baseline survey with information to contact the tele-genetics company to arrange free genetic counseling and testing. This letter will be given to the relatives directly by the study
干预措施: IGNITE-TX Group (Behavioral)
Group 2 (Free genetic testing and counseling group)
Enrolled relatives will receive a letter and baseline survey with information to contact the tele-genetics company to arrange free genetic counseling and testing. This letter will be given to the relatives directly by the study
干预措施: IGNITE-TX and free genetic testing and counseling group (Behavioral)
Group 3 (IGNITE-TX Group)
Relatives of probands randomized to the IGNITE-TX intervention will receive a family letter after enrollment and baseline survey with their personal access codes (not to be shared) to the IGNITE-TX "Hub" (access online educational material through a platform). Relatives will have also access services of a family genetic navigator. Study investigators and navigators will not directly provide genetic counseling and/or testing in this arm
干预措施: Free genetic testing and counseling group (Behavioral)
Group 3 (IGNITE-TX Group)
Relatives of probands randomized to the IGNITE-TX intervention will receive a family letter after enrollment and baseline survey with their personal access codes (not to be shared) to the IGNITE-TX "Hub" (access online educational material through a platform). Relatives will have also access services of a family genetic navigator. Study investigators and navigators will not directly provide genetic counseling and/or testing in this arm
干预措施: IGNITE-TX Group (Behavioral)
Group 3 (IGNITE-TX Group)
Relatives of probands randomized to the IGNITE-TX intervention will receive a family letter after enrollment and baseline survey with their personal access codes (not to be shared) to the IGNITE-TX "Hub" (access online educational material through a platform). Relatives will have also access services of a family genetic navigator. Study investigators and navigators will not directly provide genetic counseling and/or testing in this arm
干预措施: IGNITE-TX and free genetic testing and counseling group (Behavioral)
Group 4 (IGNITE-TX and free genetic testing and counseling group)
Relatives randomized to this arm will receive a family letter after enrollment and baseline survey with their personal access codes (not to be shared) to the IGNITE-TX "Hub" (access online educational material through a platform) and information to contact the tele genetics company. This arm will receive both the IGNITE-TX Intervention and access to free genetic testing and counseling services, as well as access to assistance from family genetic navigator
干预措施: Free genetic testing and counseling group (Behavioral)
Group 4 (IGNITE-TX and free genetic testing and counseling group)
Relatives randomized to this arm will receive a family letter after enrollment and baseline survey with their personal access codes (not to be shared) to the IGNITE-TX "Hub" (access online educational material through a platform) and information to contact the tele genetics company. This arm will receive both the IGNITE-TX Intervention and access to free genetic testing and counseling services, as well as access to assistance from family genetic navigator
干预措施: IGNITE-TX Group (Behavioral)
Group 4 (IGNITE-TX and free genetic testing and counseling group)
Relatives randomized to this arm will receive a family letter after enrollment and baseline survey with their personal access codes (not to be shared) to the IGNITE-TX "Hub" (access online educational material through a platform) and information to contact the tele genetics company. This arm will receive both the IGNITE-TX Intervention and access to free genetic testing and counseling services, as well as access to assistance from family genetic navigator
干预措施: IGNITE-TX and free genetic testing and counseling group (Behavioral)
结局指标
主要结局
Measure response rate to baseline and follow-up surveys by probands and at-risk relatives
时间窗: Up to 6 months
Measure enrollment of probands and at-risk relatives over a 6-month period
时间窗: Up to 6 months
次要结局
未报告次要终点