This pilot randomized controlled trial evaluated the TrialTalk method, a structured communication approach for discussing cancer treatment options, which includes a verbal component and a pen-and-paper diagram outlining diagnosis, prognosis, treatments, outcomes, and impacts on daily life. The study aimed to assess oncologists' ability to learn and implement the tool and its effect on clinical trial consent and enrollment. Twenty-seven oncologists from a single academic institution were randomized to an intervention group (n=14) or a control group (n=13). Intervention group oncologists completed a single 2-hour TrialTalk training program involving didactic instruction, a simulated session with patient actors, and trainer feedback, with additional support available. Control group oncologists received no TrialTalk training. Clinical trial decisions were collected from patients seen by oncologists in both groups. Results showed intervention oncologists demonstrated fidelity with the tool after training. Patients of intervention oncologists were significantly more likely to consent to participate in clinical trials than patients of control oncologists (92.9% vs. 82.4%, p=0.04). However, actual enrollment rates after signing consent were equal in both groups (78.2% in the intervention group vs. 73.3% in the control group). The study concludes that patients meeting with TrialTalk-trained oncologists were more likely to sign consent, highlighting the decision-making conversation as a critical moment for increasing trial participation.
Deciding whether to join a cancer clinical trial is one of the hardest choices a patient can face. The information is complex, and the stakes are incredibly high. This study tested whether a new way for doctors to talk about trials could help. The method, called TrialTalk, uses a simple diagram and a clear conversation to walk patients through their diagnosis, what it means, their treatment options, and how those choices might affect their daily life. In this pilot study, 27 oncologists were split into two groups. One group learned how to use TrialTalk in a single training session. The other group did not. The result? Patients who met with the TrialTalk-trained doctors were significantly more likely to sign the consent form to join a trial. About 93% of their patients consented, compared to about 82% of patients seeing untrained doctors. However, the number of patients who actually went on to enroll in a trial after signing consent was similar for both groups. The study shows that the conversation with the oncologist is a critical point. A clearer, more structured discussion can make patients more willing to consider joining a trial in the first place.
What this means for you: How doctors explain clinical trials matters—a clearer conversation leads more patients to consider joining one.
View Original Abstract ↓
INTRODUCTION: 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.