IGNITE-TX Phase III: (Identifying Individuals for Genetic Testing & Treatment) Intervention
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 2,100
- 试验地点
- 1
- 主要终点
- Safety and Adverse Events (AEs)
研究概览
简要总结
This trial aims to implement and compare an evidence- and theory-based intervention strategy (IGNITE-TX Intervention) to support probands and their ARRs in family communication, informed decision-making, and navigation to CGT with standard of care, free genetic testing/counseling, and intervention with free genetic testing/counseling.
详细描述
Primary Objectives:
- Determine the impact of IGNITE-TX on the uptake of cascade genetic testing (CGT) in at-risk relatives (ARRs) at 6 months.
- Use a mixed methods approach, guided by the NIMHD framework, to evaluate the impact of IGNITE-TX on informational, social, and emotional support outcomes within families at 6 months.
- Employ formative and process evaluations and stakeholder engagement to guide IGNITE-TX implementation and dissemination through the RE-AIM QuEST framework.
Secondary Objective:
Analyze the correlation of CGT completion rates within families to understand the influence of familial relationships on genetic testing uptake.
Determine the impact of the IGNITE-TX Intervention on the uptake of CGT, informational, social, and emotional support outcomes within families at 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •18 years of age or older
- •Speaks and reads English or Spanish
- •Resides in the United States
- •Has a pathogenic or suspected pathogenic variant in BRCA1, BRCA2, MLH1, MSH2/EPCAM, MSH6, or PMS2*
- •Has access to the internet or phone and can send and receive email and/or text messages at a US telephone number.
- •Attests to have at least one at-risk relative who meets inclusion criteria for first-degree relative
- •For cancer patients who are unaware of their mutation status, we will share existing local and national genetics resources, like those provided in the usual care family letter.
- •At-Risk Relatives (ARR):
- •18 years of age or older
- •Speaks and reads English or Spanish
- •Resides in the United States
- •Has a first or second degree relative who has a deleterious/suspected deleterious HBOC or LS variant present
- •Has access to internet or phone and can send and receive email and/or text messages at a US telephone number
- •1. Eligible SAB will include any groups connected to HBOC or Lynch syndrome, including those that focus on underserved populations or specific ethnic communities.
- •Clinicians:
- •1. Eligible clinicians will include gynecologic oncologists, general gynecologists, medical oncologists, and advanced practice providers who interact with individuals diagnosed with HBOC or Lynch syndrome and/or their at-risk relatives.
排除标准
- •Has no eligible at-risk relatives (ARRs) or is unable/unwilling to provide their contact information
- •Has negative germline genetic testing or only variant of uncertain significance
- •Unwilling or unable to provide consent
- •At-Risk Relatives (ARR):
- •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
- •1. SAB members will be excluded if they are not connected to HBOC or Lynch syndrome-related groups or if their organizations do not focus on these conditions or the communities impacted by them.
- •Clinicians:
- •1. Clinicians will be excluded if they do not provide direct care to individuals diagnosed with HBOC or Lynch syndrome or their at-risk relatives, or if they do not practice within the specified eligible clinician roles.
研究组 & 干预措施
Standard of Care
ARRs: No active efforts will be made to ensure that ARRs complete genetic testing or to support family communication and education during the period in which primary study outcomes are being evaluated.
干预措施: IGNITE-TX program (Other)
Standard of Care
ARRs: No active efforts will be made to ensure that ARRs complete genetic testing or to support family communication and education during the period in which primary study outcomes are being evaluated.
干预措施: Genetic Counseling and Testing (Other)
Free Genetic Counseling and Testing
ARRs: A letter will be provided to the ARR with instructions on how to access genetic counseling and free testing through a telegenetics company (Appendix E).
干预措施: IGNITE-TX program (Other)
Free Genetic Counseling and Testing
ARRs: A letter will be provided to the ARR with instructions on how to access genetic counseling and free testing through a telegenetics company (Appendix E).
干预措施: Genetic Counseling and Testing (Other)
IGNITE-TX Intervention
ARRs: The relatives will receive instructions with a code to access the IGNITE-TX Hub (Appendix K & L). Family Genetic Navigators will support this process by reaching out and guiding relatives through the process.
干预措施: IGNITE-TX program (Other)
IGNITE-TX Intervention
ARRs: The relatives will receive instructions with a code to access the IGNITE-TX Hub (Appendix K & L). Family Genetic Navigators will support this process by reaching out and guiding relatives through the process.
干预措施: Genetic Counseling and Testing (Other)
IGNITE-TX Intervention + Free Genetic Counseling and Testing
ARRs: The relative will be sent instructions to access free counseling and testing, as well as a unique code to log into the IGNITE-TX Hub (Appendix K & L). Family Genetic Navigators will support this process by reaching out and guiding relatives through both resources.
干预措施: IGNITE-TX program (Other)
IGNITE-TX Intervention + Free Genetic Counseling and Testing
ARRs: The relative will be sent instructions to access free counseling and testing, as well as a unique code to log into the IGNITE-TX Hub (Appendix K & L). Family Genetic Navigators will support this process by reaching out and guiding relatives through both resources.
干预措施: Genetic Counseling and Testing (Other)
结局指标
主要结局
Safety and Adverse Events (AEs)
时间窗: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
次要结局
未报告次要终点