A Phase 3 interventional study of IGNITE-TX program and Genetic Counseling and Testing in Communication and Informed Decision-making, sponsored by M.D. Anderson Cancer Center. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-17.
Sponsored by M.D. Anderson Cancer Center · Phase 3, Interventional, and Supportive care
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.
Primary Objectives:
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.
Exploratory Objective:
Evaluate the effectiveness of social media as a mechanism to drive outreach, recruitment, and engagement with the IGNITE-TX intervention.
Determine the impact of the IGNITE-TX Intervention on the uptake of CGT, informational, social, and emotional support outcomes within families at 12 months.
719 studies on the registry are indexed under Communication; 159 are open to participants now.
This study's planned enrollment of 2,100 is above the median of 144 across 571 interventional studies indexed under Communication.
Browse Communication studies →M.D. Anderson Cancer Center is the lead sponsor of 3,047 studies on the registry; 578 are open to participants now.
Of its 612 completed or terminated interventional studies of FDA-regulated products, 409 (67%) have results posted.
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Probands:
Attests to have at least one at-risk relative who meets inclusion criteria for first-degree relative
At-Risk Relatives (ARR):
SAB:
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.
Exclusion Criteria:
Probands:
At-Risk Relatives (ARR):
SAB:
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.
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.
Other: IGNITE-TX program · Other: 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).
Other: IGNITE-TX program · Other: Genetic Counseling and Testing
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.
Other: IGNITE-TX program · Other: 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.
Other: IGNITE-TX program · Other: Genetic Counseling and Testing
Participants will complete a questionnaire
Participants will complete a questionnaire
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame: Through study completion; an average of 1 year
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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