Clinical Research for American Indian and Alaskan Native Communities

CISCRP is committed to providing clear, unbiased, and culturally appropriate educational materials to engage and inform communities that have not been well represented in clinical trials.

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We developed this brochure together with members of American Indian and Alaskan Native communities, as well as subject matter experts who have experience working with these communities. This included receiving feedback from 500 members of the American Indian and Alaskan Native community through an anonymous survey.

They all helped make sure the topics, language, images, and design are appropriate and engaging. We also received feedback on how effective our brochure was for raising awareness about the importance of American Indian and Alaskan Native participation in clinical research.

This process allowed us to confirm that we are addressing the key concerns and barriers that prevent better diversity, equity, and inclusion in clinical research. This brochure was also reviewed by an Institutional Review Board (IRB), which is also known as an independent ethics committee. The IRB review ensures the brochure follows ethical guidelines for providing information about clinical research to patients and the public.

Topics include:

  • Why are Clinical Trials Important?
  • The Need for Diverse Participants in Clinical Trials
  • Why Have American Indian and Alaskan Natives Not Been Represented in Clinical Trials?
  • How American Indian and Alaskan Native Participants are Protected
  • Things to Consider Before Volunteering
  • Different Ways to Get Involved

Medical Hero Spotlight: Katie Hill, Appendix Cancer Clinical Trial Participant

Diagnosed with Appendix Cancer

Like most patients diagnosed with appendix cancer, Katie Hill had no idea her body was battling a deadly disease. Her diagnosis story began in 2021, when she made the decision to undergo a partial hysterectomy after struggling for years with pain caused by fibroids. At the hospital, her care team provided her with consent forms to read through and sign off on before the procedure. These forms gave her doctors permission to make other decisions as medically necessary if needed, a standard practice during surgeries.

“Because of COVID-19, I went in for the procedure by myself, and when I woke up in my recovery room, my surgeon let me know that there was an unexpected discovery they had made while I was under,” Katie recalls.
Her doctors had noticed an unusual spot on her appendix and decided to remove it just to be safe. Katie was informed that the team had also found some excess tissue near the appendix and abdomen, which they thought might be from endometriosis. With her appendix and tissue sent to the pathology department for testing, Katie was released from the hospital to recover at home.

Two days later, Katie noticed an email from her patient portal about her test results.

“Assuming it was nothing, I opened the email and started reading the pathology report from testing my appendix and tissue,” Katie says. “It was from that email that I learned I had Stage 4 metastatic mucinous adenocarcinoma of the appendix.”
“I remember sitting in my living room in complete shock. I didn’t know what else to do but to start Googling my cancer. It felt like a lifetime, but it was only about 5 minutes of reading before my surgeon called, interrupting my research. I could tell immediately by his voice that there hadn’t been a mistake, that this was real. Before he could say anything, I cut him off and said, ‘I know.’”

That afternoon, her surgeon had been desperately trying to prevent the hospital’s patient portal system from releasing the pathology report to Katie so that she would not learn of her diagnosis in such a clinical and shocking way. On their phone call, Katie learned a team at the hospital had been in discussions all day about her rare cancer and were researching treatment options for her.

Finding a Treatment Plan

Some patients might pull back from researching their cancer, but Katie jokes that research has always been a part of her DNA. “I needed to understand everything I could about my cancer.” 

She started by finding online resources and support, through groups like the Appendix Cancer Pseudomyxoma Peritonei Research Foundation (ACPMP), and patient support groups on Facebook. On patient forums, Katie quickly learned that it is critical for appendix cancer patients to select a specialist at a high-volume cancer center, or someone who has treated hundreds of patients with this disease.

“It used to be said that the chances of getting appendix cancer was 1 in a million. Now it’s about 2.5 in a million, so there are still not many doctors who have a lot of experience treating it,” Katie shares.

Katie spent the next week going to consultations in her home state of Pennsylvania and traveling to several appointments in New York. Within 2 weeks, she had selected her cancer specialist at Memorial Sloane Kettering.

“Part of my selection process for a specialist included finding a high-volume cancer center. I wanted a surgeon who has seen at least 100 or more cases of this a year, and I was also interested in finding a cancer center that had clinical trials available,” Katie explains. “If I have a rare cancer and have the opportunity to participate in studies that further care for other patients, I feel a duty to help.” 

Katie began treatment with chemotherapy to shrink her tumors. Her next step involved a procedure called cytoreductive surgery (CRS), which involves scraping the cancer off and, in some instances, removing organs. 

“My cancer is unique because it’s not a solid tumor, which is how most people visualize cancer. My cancer is like a jelly that spreads out across my insides, making it hard to detect on scans and then to remove.”

Joining a Clinical Trial

For Katie, clinical trial participation was a major consideration in her treatment plan, and she was fortunate to qualify for the ICARuS study. “It’s standard practice for most surgeons to use a heated chemotherapy agent as a wash to kill cancer cells. The ICARuS study is a randomized trial comparing two different methods of administering chemotherapy,” Katie explains. The purpose of the trial is to determine if outcomes for patients are different when using different types of chemotherapy.

As a rare disease patient, Katie has also had the opportunity to enroll in an observational study, called the Genetics of Appendix Cancer, or GAP study. “Right now, many appendix cancer patients use the same treatments as colon cancer patients because there is very little awareness or funding for research for this disease,” Katie explains.

“Many surgeons who run into this disease have never seen it outside of medical textbooks and oftentimes will misdiagnose or begin treatment, which could be detrimental to patients. They assume they’re doing good, but don’t realize that this is a different disease that needs to be treated differently.”

Appendix cancer was previously not considered curable, but we now know that some patients are making it for long periods of time with no evidence of disease (NED). Katie is currently 18 months NED! She hopes to be one of the patients who goes for a long time with NED but shares that she will be happy to get a couple of years without recurrence. “Our industry is moving so quickly that there will be new treatment options waiting for me down the line, which I am thankful for.”

Katie the day she arrived home after surgery, completing her treatment journey.

A Career Rooted in Life Science Collaboration

Katie has spent the last 20 years of her career working in different roles at the Drug Information Association (DIA), an organization dedicated to improving outcomes for patients through industry collaboration. Most recently, as Senior Vice President and Managing Director of Learning and Digital Solutions, Katie oversaw the development of DIA’s Patient Engagement eLearning Program, which helps to train professionals on best practices for integrating the patient perspective into the full medicines lifecycle. 

Unlike others fighting cancer, Katie wasn’t hesitant about sharing her diagnosis with her colleagues who were all incredibly supportive during her treatment. “My diagnosis was just another affirmation that the work we do at DIA is important. My colleagues and I come to work every day because of patients like me living with diseases, waiting for breakthrough treatments,” Katie shares.

For others navigating a difficult diagnosis for themselves or a loved one, Katie emphasizes that there is no ‘right’ way to move through your medical journey. “Everyone has different experiences and setbacks when dealing with a disease. I tried to maintain a positive attitude throughout my treatment, but that might not work for everyone,” Katie explains.

To newly diagnosed patients, Katie compares their upcoming medical journey to riding a rollercoaster.

“Everyone who has been on a rollercoaster knows that the scariest part is the slow climb to the top. In healthcare, most patients experience this immediately after their diagnosis, when there is so much uncertainty, fear, and often waiting. Once you’ve established a plan and found your care team, your treatment begins, and things really speed up. I know that for me, it was scary, but I felt secure knowing I had a top-notch medical team by my side and that I was making progress,” Katie says.

Additional Resources:

https://acpmp.org/ 

View an overview of the ICARuS study here.

To search for medical conditions in a specific location, visit our Search Clinical Trials page.

To stay informed about clinical trials, visit our Resources page.

For volunteer opportunities with CISCRP, visit our Volunteer page.

Written by Lindsey Elliott, Marketing & Communications Manager, CISCRP | lelliott@ciscrp.org

The Importance of Transgender and Non-Binary Inclusion in Clinical Research

Recapping the webinar in collaboration with Clario

At CISCRP, we value the importance of engaging and informing the groups that are underrepresented in clinical trials. One of these underrepresented groups is the LGBTQ+ community. Earlier this year, we published an educational brochure as a part of our Finding Treatments Together series for the LGBTQ+ community. This brochure  features topics about why LGBTQ+ volunteers are needed and how they are protected, along with providing resources on where they can go to get more information and sign up for trials.

On June 27, 2023, CISCRP partnered with Clario to host a webinar called “Working Towards a More Inclusive Environment: Transgender & Non-Binary Participants in Clinical Research.” June is Pride Month in the United States, so we thought it appropriate to have an important discussion related to LGBTQ+ topics. With a similar goal in mind, Clario approached CISCRP with the idea for a webinar project to highlight the clinical trial and healthcare experiences of the transgender and non-binary communities. The LGBTQ+ community is vast and inclusive of different sexual orientation and gender expression groups, and each of these groups have their own unique sets of challenges they encounter. For this reason, it is important to engage with each of these groups to understand their experiences.

Jae Bailey (They/Them)

Liam Paschall (He/Him)

To better understand how best to engage with members of this community, we teamed up with 2 members of the transgender and non-binary community to facilitate the webinar. Our facilitators were Liam Paschall (he/him) and Jae Bailey (they/them). Liam is a transgender man who is a consultant and public speaker who advocates for the LGBTQ+ community in efforts to create a more inclusive environment in healthcare. Jae Bailey, a non-binary artist, model, and activist, works in the clinical field and is passionate about being a voice for the LGBTQ+ community, especially within the clinical field.

 “Including transgender and non-binary people in clinical trials is crucial for equitable healthcare,” Liam said. “By including trans and non-binary people, we can enhance the understanding of how treatments affect different populations, leading to more effective and tailored healthcare for all individuals. Participating in the recent CISCRP/Clario webinar was an empowering experience. It provided an opportunity to share personal insights and challenges faced by transgender and non-binary people, advocate for improved representation, and promote better healthcare outcomes. It was a chance to foster understanding, challenge biases, and contribute to positive change in clinical research and healthcare.”

Hearing firsthand from people who are subject matter experts in their lived experience helps bring about the changes that are needed. We at CISCRP were thrilled to collaborate with Clario to organize this webinar. “There is a huge difference between knowing and feeling,” said Rosie Woolley (she/they), LGBTQ+ ERG Co-Chair at Clario. “We know there is inequality. It’s why we and CISCRP do the incredibly important work we do. However, hearing the experience of a person undergoing medical treatment and how their gender identity was not recognized made it all real again. We get caught up in statistics but moments like this make these challenges human again. Hearing one of the speakers want to ‘leap from the [operating] table’ was incredibly emotive. It’s recognizing his fear, his doubt, and his pain. Vulnerable sessions like these are what inspire people to act. The whole presentation was an excellent tour of the topic; taking people from base understanding through to the impact in clinical trials and how they can help. I would deeply recommend.”

A few major takeaways from the webinar were the steps Liam and Jae listed on what we, as a society, can do to ensure fair and equitable treatment of transgender and non-binary people in healthcare and clinical research. These include:

  • A deliberate culture shift and goal setting, such as diversity, equity, and inclusion (DEI) training for all researchers and site staff.
  • Partnership and collaboration to include transgender and non-binary community members on advisory boards, or to make adjustments to protocols, ICFs, and data collection forms. This could be as simple as including “transgender man/woman” and “non-binary” as gender options on an intake form.
  • Outreach and community engagement to improve conversations and partnerships between industry and the communities.
  • Inclusive environments, which include the use of gender-neutral language, using chosen names and pronouns, and fostering a compassionate and nonjudgmental environment.

These are just a few examples of  ways to be more inclusive of transgender and non-binary people. However, there is much work to be done. It’s not only the responsibility of healthcare workers and researchers to take action, but we, as a society, can also take steps to create a more inclusive environment for these communities. Also, these 2 groups are just a portion of the greater LGBTQ+ community. We need to think of what we can do for other community members and how to foster a more inclusive environment for all. Our work doesn’t stop here; this is just the beginning.

Written by: Zarin Tasnim

 

For more actions and insights, watch the full webinar here. 

Eligibility Criteria for Clinical Trials

Are you, or someone you know, considering joining a clinical trial? We developed this infographic to serve as a resource to better understand eligibility criteria for clinical trials.

This infographic was reviewed by an Institutional Review Board (IRB), which is also known as an independent ethics committee. The IRB ensures the brochure follows ethical guidelines for providing information about clinical research to patients and the public.

Download Infographic Here