A Randomized Trial Evaluating Personalized Versus Guideline-Based Well Follow-Up Strategies for Patients with Early...

Despite the paucity of high-quality data supporting its benefits, routinely scheduled, in-person post-treatment surveillance of early breast cancer (EBC) patients remains common. Evaluation of different follow-up strategies is required. We present the feasibility phase of an ongoing randomized controlled trial (RCT) comparing two different follow-up strategies. Patients with EBC who completed the acute phase of their treatment were randomized to receive either personalized or ASCO guideline-based follow-up care alone. Feasibility endpoints, including rate of accrual, physician participation, patient acceptance of randomization arm, and patient retention 1 year after randomization, are presented. Of 279 patients approached, 261 (93.5%) were eligible and provided consent. Median rate of accrual was 34.5 patients per month, and all healthcare providers who agreed to study participation (n = 11) approached patients. Patients were randomized to receive personalized (n = 131) or guideline-based (n = 130) follow-up. No patients declined their randomization arm. For all 261 randomized patients, the 1-year participant retention rate was 92.0% (240/261). This RCT confirms both patient and healthcare-provider enthusiasm for studies comparing different strategies for post-treatment surveillance. No patients withdrew consent post-randomization due to a preference for one study arm over the other. While clinical effectiveness and patient satisfaction remain to be analyzed, our reported rates of attrition can be used by others when designing similar studies.