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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-09245 | Other Identifier | NCI-CTRP Clinical Trials Registry |
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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:
1. Analyze the correlation of CGT completion rates within families to understand the influence of familial relationships on genetic testing uptake.
Exploratory Objective:
Evaluate the effectiveness of social media as a mechanism to drive outreach, recruitment, and engagement with the IGNITE-TX intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Experimental | 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. |
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| Free Genetic Counseling and Testing | Experimental | 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). |
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| IGNITE-TX Intervention | Experimental | 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. |
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| IGNITE-TX Intervention + Free Genetic Counseling and Testing | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IGNITE-TX program | Other | Participants will complete a questionnaire |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Through study completion; an average of 1 year |
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Inclusion Criteria:
Probands:
At-Risk Relatives (ARR):
Exclusion Criteria:
Probands:
At-Risk Relatives (ARR):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jose Alejandro Rauh-Hain, MD, MPH | Contact | (713) 794-1759 | jarauh@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Jose Alejandro Rauh-Hain, MD, MPH | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas M. D. Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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| ID | Term |
|---|---|
| D003142 | Communication |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D005817 | Genetic Counseling |
| ID | Term |
|---|---|
| D033142 | Genetic Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Genetic Counseling and Testing | Other | Participants will complete a questionnaire |
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