Clinical Trial Navigation Curriculum: Helping Patients With Breast Cancer Find Studies Using BreastCancerTrials.org

Despite the critical role clinical trials play in advancing cancer treatment, overall participation remains low, particularly among racial and ethnic minority groups.^1,2 A 2024 study reported that only approximately 7% of people with cancer participate in clinical trials.³ While this represents an improvement over the 2% to 3% participation rates from 2 to 3 decades ago, it remains far below what is needed. The NCCN encourages all patients with cancer to consider clinical trials when appropriate.⁴ However, representation remains disproportionately low; fewer than 5% of trial participants are Black, and just 2% to 3% are Latina.^5,6

Historical injustices in medical research have led to persistent medical mistrust among many racial and ethnic groups and continue to impact trial participation.⁷ Additional challenges to clinical trial participation include lack of awareness, language barriers, health insurance coverage concerns, financial toxicity, and difficulty navigating the complex clinical trial system.^8,9 Many patients are unaware that clinical trials may be available for their specific diagnosis or stage of treatment and often don’t know where to look or how to get started. Also, physicians may not consistently bring up clinical trial options during consultations.¹⁰

For patient navigators, recognizing and addressing these challenges is critical to supporting equitable access to clinical research and improving trial participation across diverse populations.

Patient navigation helps individuals overcome barriers to care by offering guidance, advocacy, education, and emotional support.¹¹ Clinical trial navigators specialize in informing patients about research studies, helping them find appropriate trials, understand eligibility requirements, and weigh the risks and benefits of participation.¹² For patient navigators, recognizing and addressing these challenges is critical to supporting equitable access to clinical research and improving trial participation across diverse populations. In response, BreastCancerTrials.org partnered with the Susan G. Komen Patient Navigation Training Program¹³ to design a 4-part curriculum to train navigators in discussing clinical trials with patients.

BreastCancerTrials.org (BCT), a program of Quantum Leap Healthcare Collaborative, is a free user-friendly website that empowers patients with breast cancer to learn about and find clinical trials. BCT matches patients to clinical trials based on their demographic, diagnosis, and treatment information. Designed with plain-language summaries and direct links to ClinicalTrials.gov, the site helps navigators and patients better understand and explore trial options. BCT provides 3 applications that serve over 75,000 unique visitors annually. Breast Cancer Trial Search (BCTS) is available for people with stage 0 (DCIS) to III breast cancer as well as breast cancer survivors and healthy/high-risk volunteers. Metastatic Trial Search (MTS) is a trial matching tool that addresses the specific and unique needs of people with metastatic (stage IV) breast cancer.

The Susan G. Komen Patient Navigation Training Program¹³ is an online training program supporting new and experienced navigators with content that is beneficial for patients, caregivers, and other members of the care team. The goal of the program is to improve access to high-quality, culturally responsive patient navigation by supporting a diverse workforce with the skills and tools needed to serve underserved communities effectively.

The Navigating Clinical Trials course was created to help patients explore potential trial options to determine if participation may be a good fit for their care plan. The 4-part training program, hosted on the Komen Patient Navigation Training website, is designed to help navigators:

1. Provide patients with information on the fundamental principles and purpose of clinical trials.
2. Find trials using BreastCancerTrials.org.
3. Understand barriers to trial participation and provide methods to overcome them.
4. Understand the importance of diverse populations in trials and ways to address bias.

Each module consists of slides with an accompanying voice-over and video demonstration of BCT. Navigators are encouraged to review all 4 modules and apply their knowledge to guide patients through a trial search on BCTS or MTS. The training program was designed for patient navigators but is equally valuable for nurse navigators, advocates, patients, caregivers, and other stakeholders.

The first module is an introduction to clinical trials and trial navigation. This module includes topics such as clinical trial basics, who can join a trial, types of trials, safety, informed consent, trial eligibility, costs, and the role of the navigator in supporting a patient who is exploring clinical trial participation.

The second module focuses on using BCT to do a clinical trial search. The module compares a ClinicalTrials.gov entry with the corresponding BCT entry that was rewritten in patient-friendly language. BCT helps with information overload by simplifying the title, purpose, what’s involved, and who the trial is designed for. The module also explains different types of trials, inclusion and exclusion criteria, and the importance of a patient knowing their biomarkers, diagnosis details, and treatment history when searching for a trial. The module includes a demonstration of how to use BCT to find trials and concludes with strategies navigators can use to help patients prepare to speak with their doctors about trials they have found and want to learn more about.

Navigators will learn tips to help support patients with patient–provider communication as well as address concerns about side effects and emotional issues, such as fear, anxiety, and hope.

The third module explores common barriers to clinical trial participation and how navigators can support patients in overcoming them. These barriers often include a lack of awareness or understanding of clinical trials, as well as challenges related to social determinants of health.¹⁴ Although approximately half of patients offered a clinical trial choose to participate, many doctors do not consistently discuss clinical trial options with their patients.^15,16 Navigators will learn tips to help support patients with patient–provider communication as well as address concerns about side effects and emotional issues, such as fear, anxiety, and hope.

The fourth module addresses health equity and the importance of enrolling a diverse population in clinical trials. Navigators will understand that a patient’s hesitation to join a research study may be partially due to knowledge of the history of unfair treatment of vulnerable populations in medical research. Acknowledging historical harms while describing current efforts to keep trial participants safe is an important topic for discussion between navigators and patients. Navigators can also teach patients that people of different backgrounds may experience disease differently, and that treatment that works for one group may not work for another, highlighting why diverse participation in the research process is so important.

To understand the user experience and satisfaction with this training, we conducted a survey of 41 navigators who completed the training. All learners completed a survey after the course completion. Nearly all (28/30; 93%) were satisfied with the program. Participants found the program understandable (30/30), useful, and relevant (29/30; 97%). Navigators who took the course reported that they were more knowledgeable about the topics covered and more confident in their ability to discuss clinical trials with patients.

The course is free, on demand, and easily accessible through a user-friendly learning management system, making it ideal for professionals looking to address barriers to clinical trial access with patients and providers. It is part of a comprehensive training program aligned with professional standards and the core competencies of patient navigation. The course also supports those seeking to bill for navigation services by addressing relevant training needs and contributing to the professional development of patient navigators.

Although responses are not anonymous, open-ended feedback has provided insight into the immediate impact of the course on professional practice and identified future learning needs.

Participants register through the learning platform, where demographic information and postprogram evaluation surveys are collected. These surveys use a combination of Likert scale and open-ended questions to assess the content, delivery methods, intent to apply what was learned, and overall satisfaction. Although responses are not anonymous, open-ended feedback has provided insight into the immediate impact of the course on professional practice and identified future learning needs. Open-ended responses offered valuable insight into the perceived relevance and applicability of the course content. One participant reflected:

I learned information I wasn’t aware of before. I feel this will help me explain the current process of clinical trials and put the patient more at ease and able to make a more informed decision.

Participant feedback will guide the development of additional training support, including the integration of case studies into the course. This study has several limitations, such as a small sample size, potential response bias, and a lack of comprehensive long-term outcome data. Nevertheless, the dissemination of this curriculum holds promise for increasing enrollment in breast cancer clinical trials, ultimately enhancing patient outcomes and improving the quality of care.

BreastCancerTrials.org and Susan G. Komen partnered to develop and offer this content in an effort to address the lack of diversity in clinical trial enrollment. Additional efforts to enhance the diversity of clinical trial enrollment include:

• ShareForCures is a breast cancer research registry that enables individuals who have been diagnosed with breast cancer to contribute their health information to accelerate scientific discovery. By expanding participation beyond a narrow subset of patients, it ensures that research will reflect the full diversity of people affected by breast cancer. The platform removes barriers so that everyone has the opportunity to take part in research. Learn more at www.komen.org/shareforcures/
• Quantum Leap Healthcare Collaborative’s I-SPY ACCESS program is a groundbreaking initiative designed to enhance access to the I-SPY family of clinical trials in historically underrepresented populations. To bridge gaps in infrastructure and provide comprehensive support both for participating sites and patients, ACCESS partners include intentionally selected institutions, such as safety-net hospitals, county hospitals, hospitals associated with historically Black colleges and universities, hospitals serving Hispanic patients, and rural and community cancer centers (www.quantumleaphealth.org)

Acknowledgment

Medical writing assistance provided by Kristine De La Torre, PhD.

References

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