Preparing Patients for Cancer Clinical Trials

Clinical trials are essential for advancing cancer treatment, but participation can be challenging for patients due to a number of factors. However, addressing these barriers is critical to ensuring diverse and equitable access to clinical trials. At the AONN+ Annual Conference in San Antonio, TX, Jackeline Castillo, LCSW, MSSW, discussed key strategies and interventions for overcoming these obstacles and preparing patients for successful participation in cancer clinical trials.

“To set up a patient for success, you have to first meet them where they’re at,” said Ms Castillo, a social worker with Mary Crowley Cancer Research in Dallas.

Understanding the Patient’s Perspective

Before even considering financial and community resources for clinical trials, it is vital to understand the patient’s current situation, she said. These assessments should be ongoing, as patients’ circumstances, perspectives, and knowledge can and will change over time.

Employing a few key assessment questions can help navigators and social workers to gain a better idea of the patient’s perspective when it comes to considering their own participation in a clinical trial:

1. What is their understanding of their cancer diagnosis? Ensure the patient comprehends their diagnosis. Without this, discussions about clinical trials may be ineffective.
   “If they don’t have a good understanding of their diagnosis, they’re probably not going to understand a conversation about clinical trials,” she noted.
2. What are their fears and worries? Identify and address the patient’s concerns and apprehensions about participation in a trial.
3. What are their information preferences? Determine how much information the patient wants and can handle at a given time.
   “This is so important,” she said. “If you’re ready to give them a whole book and they’re not ready to receive it, they may not be receptive.”
4. What are their goals of treatment? Align clinical trial options with the patient’s treatment goals.
5. Do they have any nonmedical barriers to participation? Identify and address nonmedical barriers such as logistical, financial, and emotional challenges.
6. What is their baseline understanding of clinical trials? Do they subscribe to common myths or stereotypes (ie, being a “guinea pig”)?

Overcoming Barriers to Participation

According to Ms Castillo, one of the most significant barriers for patients is the misconception that clinical trials cover all costs.

“This is the number 1 thing I deal with when patients come to our site for clinical trials,” she said.

Patients need to be educated about the costs they may incur, such as travel, lodging, and certain medical expenses. Providing clear information about financial responsibilities and available assistance is crucial before a patient can make an informed decision.

Patients also need to understand their insurance coverage, especially if considering trials out of state. Some health plans, like Medicare Advantage or certain marketplace plans, have geographic restrictions. Have the patient call their insurance company and ask for a case manager or patient navigator to help them navigate these complexities, she advised.

The time commitment required for clinical trials can be substantial, with some trials requiring daily visits or long appointment hours. Assessing the patient’s support system is essential to ensure they have reliable transportation and caregiving support they can count on, on a daily basis.

Social determinants of health, such as economic stability, education, social and community support, health status, and neighborhood environment, can significantly impact a patient’s ability to participate in clinical trials, so institutions should also continually assess and address these factors to support patient participation.

“Remember, you don’t have to know all the answers about clinical trials,” she added. “But if there’s something you don’t know, connect with experts, network, and find out.”

Empowering Patients

Educating patients about their rights and encouraging self-advocacy is critical, and empowered patients are more likely to ask questions, seek second opinions, and make informed decisions.

According to the National Institutes of Health Patient Bill of Rights, patients should be informed about their rights to receive complete information about diagnosis, treatment, and prognosis in terms that are easily understood; to receive the information necessary to give informed consent; to receive appropriate pain treatment; to refuse participation in research; and to refuse treatment to the extent permitted by law (to name just a few).

“Educating patients on their rights is a great way to empower them on what choices they have,” she added. “This is my bread and butter; this is my passion.”

The “Know Yourself” worksheet from the National Coalition for Cancer Survivorship can help both patients and providers better understand one another and align goals of care.

“Personal empowerment can mean the difference between maintaining hope and enhancing quality of life or feeling helpless and uncertain,” said Ms Castillo. “People with cancer can become self-advocates.”

Community Engagement and Resources

In addressing barriers to clinical trial participation, navigators and social workers should not work in isolation. Collaboration with clinical trial sites and pharmaceutical companies can be crucial to accessing resources.

Engaging with community partners and local nonprofits can also help identify unique resources to eliminate barriers to clinical trial participation, even if they’re not directly connected to oncology. Collaborative efforts can lead to innovative solutions, as well as more resources for patients.

Patients should always be provided with information about available resources designed specifically to assist with participation in clinical trials. These include lodging, airfare, and direct financial assistance programs. Encouraging patients to use these resources can alleviate some of the burdens associated with trial participation.

Overcoming barriers to clinical trial participation requires a multifaceted approach that includes understanding the patient’s perspective, addressing financial and logistical challenges, empowering patients through education, and fostering collaboration among healthcare providers.

“We can’t do this alone. I don’t do this alone,” Ms Castillo emphasized. “More hands make the workload lighter.”