IGNITE-TX Program for Genetic Counseling
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new program designed to help people share genetic information with their families and make informed decisions about genetic counseling and testing. It compares different strategies, including a special intervention called IGNITE-TX, free genetic counseling and testing, and the usual care approach. This study may suit individuals with a genetic variant linked to certain cancers, such as BRCA1 or BRCA2, who have family members potentially at risk. Participants need internet or phone access for communication. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking program.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It focuses on genetic counseling and testing, so it's best to ask the trial coordinators for more details.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the IGNITE-TX program, designed to assist families in discussing and deciding on genetic testing, has already been tested with participants. This indicates it has passed some early safety evaluations. In past studies, similar genetic counseling and testing have been well-received, with about 86% of participants completing their sessions without major issues.
Overall, these approaches, including the IGNITE-TX program and genetic counseling, have a history of being well-tolerated by participants. While no treatment is entirely risk-free, evidence suggests these methods are generally safe for most people.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores innovative ways to enhance genetic counseling and testing access. Unlike current options that might not actively support patients, the IGNITE-TX program pairs individuals with Family Genetic Navigators who offer personalized guidance through the genetic counseling process. Additionally, the trial provides free access to genetic testing and counseling, which can be a barrier with traditional methods. This approach aims to empower families with better information and support, potentially improving outcomes by making genetic services more accessible and user-friendly.
What evidence suggests that this trial's treatments could be effective?
Research has shown that genetic counseling and testing can significantly aid individuals and their families in understanding their health and making informed decisions. One study found that 85% of patients advised to undergo genetic testing proceeded with it, indicating that counseling clarifies genetic risks. In this trial, participants may receive the IGNITE-TX program, which aims to increase genetic testing among families with inherited conditions. Early results suggest that the IGNITE-TX program successfully raises testing rates and improves family communication. Together, these efforts can help families make better health choices.16789
Who Is on the Research Team?
Jose Alejandro Rauh-Hain, MD, MPH
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for U.S. residents aged 18 or older who speak English or Spanish, have certain genetic mutations (BRCA1/2, MLH1, MSH2/EPCAM, MSH6, PMS2), and can communicate via internet or phone. They must also have a first or second degree relative with these mutations and at least one at-risk relative.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants receive the IGNITE-TX intervention, which includes family communication support and navigation to cascade genetic testing
Follow-up
Participants are monitored for safety and effectiveness after intervention
What Are the Treatments Tested in This Trial?
Interventions
- Genetic Counseling and Testing
- IGNITE-TX program
Trial Overview
The IGNITE-TX Phase III trial tests an intervention strategy to help individuals understand their genetic risks and make informed decisions about genetic testing and counseling compared to standard care which includes free testing/counseling.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
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.
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.
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.
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).
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
Citations
Systematic evidence review and meta-analysis of outcomes ...
We conducted a systematic review and meta-analysis of 17 patient-reported and health-services-related outcomes associated with pre- and post-test GC in GCRA.
A Systematic Review of the Impact of Genetic Counseling on ...
The results suggest that genetic counseling may have a positive impact on risk perception accuracy, though some studies observed no impact at all.
Genetic Counseling and Testing in a Community Setting
At the conclusion of the initiative, rates of referral successfully increased to 87%, and 85% of referred patients completed genetic testing.
Genetic counselling considerations with genetic/genomic ...
Genetic and genomic technologies can effectively diagnose numerous genetic disorders. Patients benefit when genetic counselling accompanies ...
Cancer Genetics Risk Assessment and Counseling (PDQ®)
Posttest genetic counseling helps patients understand their test results, including the medical implications for themselves and their relatives.
Genetic Counseling, Testing, and Family Communication ...
To examine receipt of genetic testing and communication with relatives about results into survivorship after diagnosis of breast cancer.
Understanding the Uptake and Challenges of Genetic ...
30% of providers reported they would be comfortable completing genetic counseling themselves and identified barriers to provide genetic testing themselves were ...
Randomized control trial comparing genetic counseling ...
3.2. Genetic counseling and testing completion. In total, 86% (272/317) of enrolled participants completed their scheduled genetic counseling ...
Genetic Counseling Insights: How Screening Helps ...
Genetic counseling and screening have transformed modern healthcare by enabling the early identification of genetic risks and informing ...
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