Understanding the Patient Journey: Barriers, Facilitators, and Expectations in Joining a Chemotherapy De-escalation Trial Among Premenopausal Patients with Breast Cancer

Background: De-escalation trials aim to balance clinical outcomes and quality of life (QoL), especially for premenopausal women with early breast cancer (BC), who often experience a greater treatment burden affecting their physical and psychosocial wellbeing.We sought to understand their patient journey-barriers, facilitators, and expectations-when joining de-escalation trials to inform patient-centered design and implementation.Methods: OPTIMA-YOUNG, an EU-co-funded international trial, investigates a genomic assay-guided approach to de-escalate chemotherapy in premenopausal patients with early-stage hormone receptor (HR)+ BC.A Co-creation Board of patients and healthcare professionals (HCPs) ensured stakeholder involvement throughout the trial.Focus groups (FGs) explored decision-making, needs, and QoL priorities related to joining a de-escalation clinical trial.Discussions were recorded, transcribed, anonymized, and analyzed using MAXQDA software.Results: The three FGs included 20 participants (11 patients, 9 HCPs) from 14 countries.Three themes emerged: 1) emotional and cognitive responses to BC diagnosis/treatment; 2) environmental, HCP, and social influences on choices; 3) coping with side effects and QoL challenges.Barriers to joining a de-escalation trial included limited emotional support at diagnosis, cross-country variations in shared decisionmaking, poor communication on long-term side effects, fear of recurrence, and HCPs' tendency to overtreat younger patients.Developing training for patients and HCPs was seen essential for improving communication, shared decision-making skills, and enhancing symptom management and QoL.Conclusions: This pre-implementation study identified factors at the patient, HCP, and system levels that, if addressed, could improve the trial experience.Insights helped refine the OPTIMA-YOUNG protocol and implementation plan and may inform future deescalation trials.