Ignite-TX Study | YMyHealth

Q&A with Dr. Alejandro Rauh-Hain and Dr. Karla Barajas from MD Anderson Cancer Center

Dr. Alejandro Rauh-Hain is the principal investigator of the IGNITE-TX study and works in the Department of Gynecologic Oncology and Reproductive Medicine at MD Anderson Cancer Center. Dr. Karla Barajas is a research fellow on the study from the same department.

What does the current landscape look like for hereditary breast cancer, ovarian cancer syndrome, and Lynch syndrome in the United States?

Dr. Barajas: We're talking about two of the most important inherited cancers. While they're not extremely rare, they're very highly undiagnosed or underdiagnosed. For hereditary breast and ovarian cancer, there's about one in 400 people who have the mutation. For Lynch syndrome, there's an estimate of about one in 300 people. If you add that up, there are millions of people in the United States who have these mutations.

The most alarming part is that a lot of them don't even know they have the mutation - 52% up to 90% have not been diagnosed. This matters because these are real people who could actually do something about it, knowing that they carry this cancer risk and taking action to prevent cancer.

What inspired you to create the IGNITE-TX study?

Dr. Rauh-Hain: These days we're very good at testing patients that already have cancer. If I see a patient with ovarian cancer in my clinic, the chance that we're going to test for one of these mutations is close to 100%. What we're not very good at is testing the family members.

This is important because if you identify one family member with a BRCA mutation or Lynch syndrome, their first or second degree relatives have a 50% chance of having this mutation. I was seeing patients undergoing treatment, and then suddenly their family members were also coming to see me with breast cancer or ovarian cancer. Many family members knew their relative had BRCA, but they just didn't get tested themselves.

Dr. Barajas: I've always been interested in women's health, particularly giving healthcare access to underserved communities. I was raised in Mexico, and one of the bigger issues I would see there was healthcare access for women, particularly from underserved communities. When I moved to the US, I wanted to focus on prevention and research that could tackle issues before they happen.

What did prior research tell you about family communication and genetic testing?

Dr. Rauh-Hain: What's very clear is that if we diagnose someone with BRCA, that patient will very likely tell their family members they're at risk and should get tested. The communication happens - family members just don't get tested. Overall, maybe 20% to 50% of the time family members get tested, and those numbers are even lower in rural areas and underserved communities.

There are many reasons family members don't pursue testing. They need to understand what a mutation is, what it means for cancer risk, and then they may experience fear about what they'll do with the information or concerns about insurance. The important thing is that there are actually many things they can do if they have the mutation - they can prevent cancer through screening and preventive surgeries.

Can you explain what a pilot study is and why you started with one?

Dr. Barajas: A pilot study is like a smaller, earlier version of a large-scale study - think of it as a test run to see what works and what doesn't work, and what adjustments need to be made. In our case, it was extremely important because we were able to try different outreach methods to find people with mutations and see what was feasible in the real world.

We explored questions like: Are people ready to talk about this? Are they willing to talk to their family members? Are family members willing to undergo genetic testing? What's the best way to find people - through healthcare providers, genetic companies, or social media? By doing a pilot study, you can learn and adapt in real time.

J. Alejandro Rauh-Hain, MD, MPH, is a
Gynecologic Oncologist in the
Department of Gynecologic Oncology and Reproductive Medicine, at MD Anderson Cancer Center.

How was the IGNITE-TX study designed?

Dr. Rauh-Hain: Currently, when a patient with BRCA comes to MD Anderson, our genetic counselors give them a piece of paper explaining the mutation and telling them to communicate with family members about getting tested. That's the standard of care and one arm of our study.

We wanted to see whether an intervention called IGNITE-TX would be more effective. This intervention includes access to a website with educational videos and a genetic patient navigator - someone who calls and helps navigate barriers to getting tested.

Dr. Barajas: We found people with mutations through healthcare providers, genetic testing companies, social media, and community outreach. They could self-enroll through our website in just two minutes. Once enrolled, they provided information about their first and second-degree relatives who hadn't been tested.

We then reached out to relatives, who could also enroll easily. They were randomized into four different groups:

Standard of care - Just received a letter stating their relative has a genetic mutation
Free testing access - Letter with instructions for free genetic testing and counseling, but no active follow-up
Intervention arm - Patient navigator using motivational interviewing plus educational videos
Full package - Patient navigator, videos, and free genetic testing

What do the educational modules include?

Dr. Barajas: I really like the videos because there's so much information online today, and it's easy to get misinformed or overwhelmed. Our educational videos help participants know they're receiving good information from professionals in the field.

For people with mutations, the videos address understanding genetics basics - what is hereditary breast and ovarian cancer, what is Lynch syndrome, how to share results with relatives, and tools for having those conversations. There's also a module about social support and finding organizations aligned with their genetic mutations.

For relatives, the videos answer questions like: What does it mean that my relative has a positive mutation? What does it mean for me? They also address cost, insurance, and genetic discrimination concerns. The videos are short, interactive, and not mandatory - we want them to be accessible without pressure.

Karla L. Barajas, MD, is a Research Fellow in the Department of Gynecologic Oncology and Reproductive Medicine at MD Anderson Cancer Center who is the study coordinator for IGNITE-TX.

What were the preliminary results from the pilot study?

Dr. Barajas: We're still analyzing data, but overall we're seeing that as you scale from arm one to arm four, the more support you offer - whether through free genetic testing, education, or emotional guidance - the more likely people are to get tested.

There was approximately 3% to 5% of relatives who got tested in arm one, which is extremely low. When you compare that with arm four, about 75% to 80% of relatives have been tested. You can see there's a huge gap, and there's clear progression as you go from arm one to arm four.

Why do you need a larger study?

Dr. Rauh-Hain: These preliminary results aren't statistically powered to detect differences. For the pilot study, we only enrolled 60 people with mutations and around 144 relatives. While that's not small, it's not enough to statistically show differences between groups.

When we ran statistics to show clinically relevant and statistically significant differences, we determined we need a study of 700 people with mutations and around 1,400 relatives. The differences between 5% and 75% are truly remarkable and suggest there's a real need for these behavioral interventions, but we need larger numbers to prove it statistically.

Who are you looking for in the larger study?

Dr. Rauh-Hain: We're looking for patients with BRCA1, BRCA2, or Lynch syndrome - those are the only hereditary cancers we're including currently. The only age requirement is being over 18 years old. Both the person with the mutation and their relatives need to live anywhere in the United States.

What's the time commitment for participants?

Dr. Barajas: We've tried to keep the burden as light as possible. This is a self-enrollment study that can be done on a phone or computer. There are only about five surveys total, each with approximately 10 questions, taking about two minutes each to complete.

It's really more about people being ready to share results with relatives and relatives being proactive about pursuing genetic testing. Depending on which arm participants are randomized to, those with patient navigator access might have more engagement, but overall the time commitment is minimal.

How can people get involved when recruitment starts?

Dr. Rauh-Hain: It's very easy to enroll. Just visit our website at igniteTX.com. The patient who enrolls is the one with the mutation, and we ask that they upload their genetic testing results. We ask basic questions about name, contact information, upload the test, and provide contact information for relatives.

We've worked very hard over years to make enrollment as simple as possible. The whole process takes less than 10 minutes, including signing consent electronically. In three of the four arms, family members get some kind of help for free, so 75% of the time participants receive some benefit.

We're hoping to open the larger study in the next six months, and there will be significant promotion through social media, genetic testing companies, and other channels.

Why is participating in IGNITE-TX important?

Dr. Barajas: You're helping us find the best way for future generations to access genetic testing and helping improve public health. At the same time, you're getting something back - 75% chance of receiving some benefit. If you complete genetic testing and learn whether you have a mutation, that's extremely important information that could potentially change your life's trajectory.

You can start taking measures like earlier screenings, preventative surgeries, or medications. All of these could potentially save your life. While genetic testing might not look very important initially, all the outcomes that come with it are extremely important and could really benefit those who need it.

What are your hopes for how IGNITE-TX findings will impact preventive care?

Dr. Barajas: My biggest hope is to help shift healthcare system focus toward being more proactive with preventative measures. We now have tools to prevent cancer altogether rather than just treat it after diagnosis. It's an amazing tool we should take advantage of, but it's not talked about enough.

With increasing cancer rates, many people don't realize we have tools that could help save their lives and prevent cancer altogether. We should normalize conversations about family history and hereditary cancer, and change the narrative about what hereditary cancer means.

Dr. Rauh-Hain: I echo what Karla said about raising awareness of hereditary cancer risks. We have very effective strategies through cascade genetic testing to identify at-risk relatives. If someone is diagnosed with BRCA or Lynch syndrome, we have very effective strategies to decrease their chances of developing cancer. It's much better to prevent cancer through surgeries and screening than to wait until someone develops cancer, when the prognosis is often poor.

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IGNITE-TX Study: Improving Genetic Testing for Hereditary Cancer