Supportive Care in Cancer: Improving Clinical Trial Conversations

A pilot randomized controlled trial showing that the TrialTalk method increases patient consent for clinical trials by improving clarity in decision-making conversations.

Clinical trials don’t just hinge on eligibility—they hinge on conversations. And too often, those conversations are confusing, rushed, or hard for patients to fully grasp.

This study explores what happens when you give clinicians a simple, structured way to talk through options using the TrialTalk method. The result? More patients felt confident enough to say yes to participating.

It’s a reminder that how we communicate isn’t a “soft skill”—it directly shapes real medical decisions. If you’ve ever wondered why trial participation is so low—or what actually moves the needle—this paper offers a clear, evidence-backed answer.

Abstract

Structured, easy-to-interpret approaches are needed to facilitate preference-sensitive decision-making about cancer treatments. The TrialTalk method incorporates a verbal component and a pen-and-paper diagram that outlines the diagnosis, prognostic implications, treatment options, potential outcomes, and anticipated impacts on daily life. This pilot study examined (1) oncologists’ ability to learn and then implement the tool in their clinical practice and (2) the effect of the TrialTalk method on clinical trial consent and enrollment.

Methods

Twenty-seven oncologists from a single academic institution were randomly assigned to the intervention group (n=14) or the control group (n=13). Intervention group oncologists completed a single, 2-hour TrialTalk training program, including a didactic, simulated session with patient actors and feedback from the trainer. Additional feedback and question/answer sessions were available. Oncologists in the control group did not receive TrialTalk training. Clinical trial decisions were collected from patients seen by oncologists in both groups.

Results

Intervention oncologists demonstrated fidelity with the tool after training. Patients of oncologists in the intervention group were significantly more likely to consent to participate in clinical trials than patients of oncologists in the control group (92.9% vs. 82.4%, p=0.04). Actual enrollment rates after signing consent were equal in both groups (78.2% in the intervention group vs. 73.3% in the control group).

Conclusion

Patients who met with TrialTalk-trained oncologists were more likely to sign consent to participate in a clinical trial. The decision-making conversation with the oncologist is a critical moment for patients considering clinical trial participation, and targeting these encounters has the potential to increase overall trial participation rates.

Trial registration ClinicalTrials.gov ID: NCT03656276.