An Evidence-Based Approach to Discussing Clinical Trials WIth Your Patients 

Clinical Relevance: Research shows that discussions with patients about participating in a clinical trial can help enhance their understanding while making sure they feel supported.

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For patients undergoing cancer treatment, the sting of exhausted treatment options hangs heavy. But amid this discouragement, clinical trials can offer the potential for survival and perhaps, a chance to contribute to medical progress. 

“The National Comprehensive Cancer Network believes that the best management for any patient with cancer is in a clinical trial,” Dr. Miriam Eskander, a surgical oncologist and assistant professor in the division of surgical oncology at the Rutgers Robert Wood Johnson Medical School says.

“So I want to say that upfront — clinical trials are not the last resort. They can actually be a first resort. And so I bring them up early. I include them in the list of treatment options I have for a patient,” she says. 

Yet discussing a clinical trial is not always the easiest doctor-patient conversation to have. Explaining the complexities of experimental treatment can be daunting. There are few evidence-based resources to consult for guidance. 

“To some people, a clinical trial sounds sort of risky, and there may be some negative connotations associated with the word. But that’s really a misnomer because clinical trials are safe.” Dr. Eskander says.

Eskander believes it’s all about how you present the idea to the patient.

 “I frame it as an opportunity, like an opportunity to choose a path that may be better than the standard treatment that we currently have,” she says.

Pioneering Research

A National Cancer Institute (NCI)-funded research team, led by Dr. Eric Kodish, a professor at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, has created an approach for discussing clinical trials with patients.

Their research provides practical advice for improving patient conversations about clinical trials by stressing the importance of a sequenced approach that, at the bird’s eye level boils down to three basic steps:

• Assess the patient’s understanding of the disease
• Discuss current standard treatment
• Broach the possibility of a clinical trial.

The study took these steps and expanded them into a detailed, modified checklist for physicians to use as a model for these kind of discussions, with the goal of empathically supporting the patient while enhancing their understanding of the process and encouraging their participation in the clinical trial process. 

Although the checklist was originally developed for use in pediatric oncology, the authors stress that it can be applied to any patient population.

Related: Everything You Need to Know About Clinical Trials

The Modified Checklist

This 19-point checklist is designed to ensure that discussions about clinical trials are conducted in an informed, respectful, and patient-centered manner, facilitating understanding and empowering patients to make informed decisions about their participation.

• Provide an Empowering Environment: Invite the patient to choose who will be present during the discussion to create a supportive atmosphere.
• Focus on the Discussion: Hold the meeting in a private location without interruptions to increase the patient’s ability to concentrate.
• Communicate Respect: Acknowledge the trauma of diagnosis (if appropriate) and empathize with the patient’s emotional reactions to show respect and the importance of the meeting.
• Simplify Information: Avoid medical jargon and simplify the presentation of information. Summarize often and repeat important points for clarity.
• Encourage Note-Taking and Questions: Provide a pen and paper for the patient to take notes and encourage them to ask questions at any time.
• Stress Information-Seeking: Elicit questions in an open-ended manner to encourage the patient to seek more information.
• Avoid Interrupting: Listen attentively and ensure the patient feels heard by not interrupting them.
• Ensure Questions Are Answered: Check that all the patient’s questions have been answered to their satisfaction.
• Discuss Benefits of Clinical Trials: Talk about how disease treatments have improved over time through clinical research and patient participation.
• Maintain Neutrality: Avoid pushing the recommendation of a clinical trial, but respond appropriately if asked.
• Explain the Disease and Treatment Sequence: Follow a sequence of explaining the disease, describing the current best treatment, and then presenting the clinical trial option.
• Consider Two Meetings: Break the informed consent conference into two meetings if it could enhance understanding.
• Use the Consent Document: Use the consent document as a tool to aid communication, providing copies and referring to it during discussions.
• Discuss Treatment Options: Explain how the clinical trial differs from current standard treatments and discuss options outside of the trial.
• Clarify Voluntary Participation: Emphasize that participation is voluntary and explain the right to withdraw at any time.
• Clarify Randomization Process: Use examples to explain the randomization process and avoid misleading descriptions.
• Use Diagrams: Employ diagrams to illustrate the differences among the trial groups if applicable.
• Address Potential Conflicts of Interest: Be transparent about any conflicts of interest as an investigator.
• Personal Enrollment Perspective: Be prepared to answer if you would personally enroll in the trial or recommend it to family members.

Locating a clinical trial

If you and your patient agree that a clinical trial may be right for their situation, there are many active clinical trials in the U.S. You can review SurvivorNet’s Clinical Trial Finder to identify the best one for your patient.