Contemporary Clinical Trials Communications (Feb 2025)
“Salud Mamaria”, an internet-based psychoeducational program during the breast cancer diagnosis process: Protocol for a randomized controlled trial
Abstract
Background: Some of the key challenges during the breast cancer diagnosis process include a lack of information and negative psychological consequences, such as distress and anxiety about the process. Implementing a psychoeducational program during the diagnosis process may enhance the well-being of women. “Salud Mamaria” is an Internet-Based Psychoeducational Program (IBPP) that comprises three interventions: A (“Improving Your Health Habits and Self-Care”), B (“Waiting for the Result of Your Biopsy”), and C (“Supporting You After Your Breast Cancer Diagnosis”). Objective: 1) To evaluate changes in the study variables following each of the three interventions (A, B, and C), and 2) To assess the differences in study variables between the IBPP and an active control group. Methods: This is a superiority trial employing an experimental design with two independent groups: an experimental group and an active control group. All participants will be randomized to one of the two conditions. Anxiety symptoms, negative screening of consequences, sense of coherence, satisfaction with the intervention, and system usability will be measured. Patients will be assigned to an intervention based on their clinical situation: without cancer suspicion (A), with cancer suspicion (B), or diagnosed with cancer (C). Questionnaires will be administered via the online platform before and after each intervention. Conclusions: A psychoeducational program implemented during the breast cancer screening and diagnosis process may promote the health and well-being of women. It may also encourage adherence to medical screening recommendations, mitigating the lack of information and reducing associated distress. Trial registration: ClinicalTrials.gov NCT05830461.
