Patient selection
intellectual disability
DEL, BREAST CANCER DIAGNOSIS, RECRUITMENT
This study is a parallel‐arm, multicenter, international, unblinded, randomized clinical trial. Women aged ≥18 years with a recent breast cancer diagnosis (i.e., <6 months) who were yet to start systemic therapy (i.e., chemotherapy, hormone therapy, anti‐HER2 agents, and immunotherapy) were eligible to participate if they were scheduled for their first medical oncology appointment on which they would discuss their systemic therapy options. Exclusion criteria included known intellectual disability and inability to read or write.Participant recruitment was undertaken in eight centers: Hospital Zambrano Hellion, San Pedro Garza Garcia, Mexico (05/2021–03/2022); Hospital Regional del Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado, Leon, Mexico (05–12/2021); Hospital de Gineco‐Obstetricia No. 4 “Luis Castelazo Ayala,” Mexico City, Mexico (10–12/2021); Unidad Medica de Alta Especialidad del Instituto Mexicano del Seguro Social, Merida, Mexico (08/2021–02/2022), Centro Médico Nacional de Occidente, Guadalajara, Mexico (11/2021–03/2022), Centro de Educación Medica e Investigaciones Clínicas “Norberto Quirno,” Buenos Aires, Argentina (01–03/2022), Hospital General de Mexico, Mexico City, Mexico (09/2021–02/2022), and Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (10–12/2021). All consecutive, eligible patients were invited to participate. Those who consented were randomized in a 1:1 ratio in blocks of two, four, or six patients using the Sealed Envelope websiteSample size was calculated hypothesizing the proportion of patients that correctly identified their molecular subtype would be 20% greater in the customizable brochure group compared to the standard brochure group. A total of 194 participants were deemed necessary to detect a 20% difference with a power of 80% and an alpha of 0.05. Patient recruitment phase ended once the anticipated number of participants needed was achieved.