Clinical Trial Catalyst: Navigator’s Role in Understanding Molecular Profiling and Locating/Identifying Clinical Trials

September 2024 Vol 15, No 9
Kendra Paabo, BSN, RN
Manager of Patient Navigation, Brain Tumor Network
Jennifer West, BSN, RN, CCRC, ONN-CG
Clinical Trial Nurse Navigator, University of Florida

C-A-N-C-E-R. Hearing this word be delivered for the first time can be overwhelming, daunting, and downright devastating for our patients. The world as they knew it has just forever been changed: their priorities have drastically shifted, their understanding of their health and body is different, their financial stability may be in jeopardy, and they may be examining aspects of life they’ve never questioned or closely assessed before, like mortality or spirituality.

The early introduction of navigation at the time of initial diagnosis is essential, so that we can begin building a foundation of trust with our patients through these difficult times. Not only are patients grappling with a new cancer diagnosis, but what they’re likely unaware of is the bombardment of medical jargon that is quick to follow. Terms like “biomarkers,” “germline testing,” “immunotherapy,” and “molecular profiling” will soon become part of their normal vernacular.

Navigators have the ability and privilege to empower patients through education, to help them gain confidence, and to not feel intimidated by important discussions about personalized medicine and their course of treatment. Instead, with a navigator’s support, patients can become part of the healthcare team and active participants in their care by engaging in these discussions directly.

Not only does biomarker testing allow oncology care teams to offer a more personalized approach to treatment, but having a specific gene mutation may open the door to additional treatment options through clinical trial enrollment or expanded access programs. With the evolving role of genetics and molecular testing in cancer care, navigators must have a working knowledge of these concepts and how they impact the specific disease populations we support.

Let’s review some key terms:

  • Next-generation sequencing: A method used to determine a portion of an individual’s genome utilizing DNA sequencing
  • Genetic testing: The study of genes, the way traits or conditions are passed down from one generation to another
  • Biomarker/molecular testing: Tests used to determine if a person has inherited mutations that make them more likely to get cancer. They can also tell how a person’s cancer will respond to certain medications. Having these results will allow treatment to be tailored to a patient’s specific mutation
  • Immunotherapy: Cancer treatment that uses the body’s own immune system to prevent, control, and eliminate cancer
  • Targeted therapy: Drugs that keep cancer from growing and spreading with less harm to noncancerous cells
  • Chemotherapy: Drugs that work by killing/destroying existing cancer cells, but also healthy cells

Testing is conducted through a variety of methods and companies. Many hospitals are doing next-generation sequencing at the time of biopsy, delaying the time to initial treatment to identify if a particular mutation is present, and thus informing the physician of additional treatment options to consider. There are a number of companies that perform these comprehensive genomic profiling tests, such as CARIS, TEMPUS, Foundation Medicine, and Guardant Health, to name a few. Depending on what mutations are being assessed, certain tests can be performed on saliva or blood samples (also known as liquid biopsies) if tumor tissue is not available. Some of the testing companies offer local and virtual support to patient navigators, so do your research and explore what resources are at your disposal.

Why Is Testing Important?

Per National Comprehensive Cancer Network guidelines, there are disease-specific mutations that, if present, have approved related therapy options associated (Table).

Locating and Identifying Clinical Trials

With cancer treatments evolving, our role as navigators must evolve along with them. This means we must stay informed about not only the specific cancers we navigate but also the ever-expanding array of treatment options available. As integral members of the oncology team, navigators play a crucial role in connecting patients to their next phase of care, which may include access to the latest cutting-edge research through clinical trial participation.

If you have access to a portfolio of clinical trials at your facility, within your community, or through the internet, having an understanding of how to access clinical trials that will benefit your patients is essential.

After confirming your patient’s interest in trial participation, provide them with resources so they can educate themselves, begin asking informed questions, and set realistic expectations. Connect with your facility’s clinical trial coordinator, research nurse, or clinical trial navigator for assistance reviewing trial enrollment criteria for your patient. Let your patient’s oncologist know the patient is interested in clinical trials and help facilitate a conversation if needed.

If your facility isn’t a host to clinical trials, consider searching nearby institutions and universities. There are several online search tools available to help identify potential clinical trial options for patients nationwide as well.

Find some popular nationwide and cancer-specific online resources for your personal navigation practice:

Nationwide Clinical Trial Search Tools

  1. ClinicalTrials.gov – https://clinicaltrials.gov
  2. National Cancer Institute – www.cancer.gov/research/participate/clinical-trials-search
  3. National Institutes of Health – https://clinicalstudies.info.nih.gov

Cancer Advocacy Groups

  1. Pancreatic Cancer Action Network – https://clinicaltrials.pancan.org
  2. Leukemia & Lymphoma Society – www.lls.org/treatment/types-treatment/clinical-trials
  3. Breast – www.komen.org/clinical-trials
  4. Colorectal Cancer Alliance – https://colorectalcancer.org/treatment/types-treatment/clinical-trials
  5. American Lung Association – www.lung.org/research/clinical-trials/find-a-clinical-trial
  6. Brain Tumor Network – www.braintumornetwork.org/get-support

Privately Owned

  1. TriCan Health – www.tricanhealth.com
  2. Cancer Research Institute + Carebox – https://cri.careboxhealth.com

As navigators, our commitment to patient care extends far beyond initial diagnosis and continues throughout the cancer continuum. The landscape of cancer treatments is constantly evolving, and so must our pursuit of continued learning. By staying informed about advancements in molecular profiling and the latest clinical trials available for the patient populations we serve, we can help ensure our patients receive the most personalized navigation support available.

We serve as a critical link connecting patients to the latest clinical research and innovative therapies. These modern medical advancements may extend life, provide a source for hope, and offer new treatment possibilities where no current cure exists.

Sources

  • Benson AL. Understanding the Role of Biomarkers in Treating Cancer. CancerCare. 2024. Accessed July 10, 2024. www.cancercare.org/publications/413-understanding_the_role_of_biomarkers_in_treating_cancer
  • Cancer Research Institute. Immunotherapy By Cancer Type. www.cancerresearch.org/immunotherapy-by-cancer-type
  • Cancer Support Community. Immunotherapy for Cancer: Is it Right For You? www.cancersupportcommunity.org/immunotherapy
  • dela Rama F; Klemp J, Martin N, et al. Patient Navigation in Cancer Care 2.0: Guiding patients to quality outcomes. Precision Medicine Toolkit: A Resource Guide for the Navigator; 2022. Pfizer. https://navigatorroundtable.org/resource/pfizer-care-2-0
  • Health Information National Trends Survey. HINTS 5 Cycle 4. 2020. https://hints.cancer.gov/docs/Instruments/HINTS5_Cycle4_AnnotatedInstrumentEnglish.pdf
  • National Cancer Institute. Next-generation sequencing. www.cancer.gov/publications/dictionaries/genetics-dictionary/def/next-generation-sequencing
  • National Comprehensive Cancer Network. https://education.nccn.org/sites/default/files/course/2023-05/04_CNS_Horbinski%2C%20Lukas_NCCNbio23_v1.pdf
  • National Comprehensive Cancer Network. Webinars for Patients. www.nccn.org/professionals/physician_gls/pdf/kidney.pdf

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