IGNITE-TX Phase III: (Identifying Individuals for Genetic Testing & Treatment) Intervention
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
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.
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Jose Alejandro Rauh-Hain, MD, MPH
- Phone Number: (713) 794-1759
- Email: jarauh@mdanderson.org
Study Locations
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Texas
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Houston, Texas, United States, 77030
- The University of Texas M. D. Anderson Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Probands:
- 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
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:
- 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
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
Participants will complete a questionnaire
Participants will complete a questionnaire
|
|
Experimental: 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).
|
Participants will complete a questionnaire
Participants will complete a questionnaire
|
|
Experimental: 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.
|
Participants will complete a questionnaire
Participants will complete a questionnaire
|
|
Experimental: 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.
|
Participants will complete a questionnaire
Participants will complete a questionnaire
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Safety and Adverse Events (AEs)
Time Frame: 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
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Through study completion; an average of 1 year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jose Alejandro Rauh-Hain, MD, MPH, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-1276
- NCI-2025-09245 (Other Identifier: NCI-CTRP Clinical Trials Registry)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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