“Salud Mamaria”, an internet-based psychoeducational program during the breast cancer diagnosis process: Protocol for a randomized controlled trial

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...

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Main Authors: Reyna Jazmín Martínez-Arriaga, Alejandro Dominguez-Rodriguez, Sergio Osvaldo Meza-Chavolla, Yineth Alejandra Muñoz-Anacona, Adrián Antonio Cisneros-Hernández, Joel Omar González-Cantero, Leivy Patricia González-Ramírez, Paulina Erika Herdoiza-Arroyo, Norma Alicia Ruvalcaba-Romero, Fabiola Macías-Espinoza, Said Jiménez
Format: Article
Language:English
Published: Elsevier 2025-02-01
Series:Contemporary Clinical Trials Communications
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Online Access:http://www.sciencedirect.com/science/article/pii/S2451865424001443
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author Reyna Jazmín Martínez-Arriaga
Alejandro Dominguez-Rodriguez
Sergio Osvaldo Meza-Chavolla
Yineth Alejandra Muñoz-Anacona
Adrián Antonio Cisneros-Hernández
Joel Omar González-Cantero
Leivy Patricia González-Ramírez
Paulina Erika Herdoiza-Arroyo
Norma Alicia Ruvalcaba-Romero
Fabiola Macías-Espinoza
Said Jiménez
author_facet Reyna Jazmín Martínez-Arriaga
Alejandro Dominguez-Rodriguez
Sergio Osvaldo Meza-Chavolla
Yineth Alejandra Muñoz-Anacona
Adrián Antonio Cisneros-Hernández
Joel Omar González-Cantero
Leivy Patricia González-Ramírez
Paulina Erika Herdoiza-Arroyo
Norma Alicia Ruvalcaba-Romero
Fabiola Macías-Espinoza
Said Jiménez
author_sort Reyna Jazmín Martínez-Arriaga
collection DOAJ
description 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.
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spelling doaj-art-79028d0b6c434d9faa21ebbad886986e2025-01-12T05:25:29ZengElsevierContemporary Clinical Trials Communications2451-86542025-02-0143101397“Salud Mamaria”, an internet-based psychoeducational program during the breast cancer diagnosis process: Protocol for a randomized controlled trialReyna Jazmín Martínez-Arriaga0Alejandro Dominguez-Rodriguez1Sergio Osvaldo Meza-Chavolla2Yineth Alejandra Muñoz-Anacona3Adrián Antonio Cisneros-Hernández4Joel Omar González-Cantero5Leivy Patricia González-Ramírez6Paulina Erika Herdoiza-Arroyo7Norma Alicia Ruvalcaba-Romero8Fabiola Macías-Espinoza9Said Jiménez10Departamento de Clínicas de Salud Mental, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, 950 Sierra Mojada St, Independencia, 44340, Guadalajara, Jalisco, MexicoDepartment of Psychology, Health and Technology, University of Twente, Drienerlolaan 5, 7522, NB, Enschede, Netherlands; Corresponding author.Unidad de Detección y Diagnóstico Cáncer de Mama, Instituto Mexicano del Seguro Social, OOAD Jalisco. Belisario Domínguez 3005 Av., Jardines de Santa Isabel, 44300, Guadalajara, Jalisco, MexicoDepartamento de Ciencias del Comportamiento, Centro Universitario de los Valles, Universidad de Guadalajara, 46600, Carretera Guadalajara – Ameca Km. 45.5, Ameca, Jalisco, MexicoDepartamento de Proyectos de Comunicación, Centro Universitario de Arte, Arquitectura y Diseño, Universidad de Guadalajara, 5075 Independencia Norte, Huentitán El Bajo, 44250, Guadalajara, Jalisco, MexicoDepartamento de Ciencias del Comportamiento, Centro Universitario de los Valles, Universidad de Guadalajara, 46600, Carretera Guadalajara – Ameca Km. 45.5, Ameca, Jalisco, MexicoSchool of Medicine and Health Sciences, Tecnologico de Monterrey, Guadalajara Campus. 2514 Gral Ramón Corona Av., Nuevo México, 45201, Zapopan, Jalisco, MexicoFaculty of Medical, Health and Life Sciences, Universidad Internacional del Ecuador UIDE, Jorge Fernandez, 170411, Quito, EcuadorDepartamento de Psicología Básica, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, 950 Sierra Mojada St., Independencia, 44340, Guadalajara, Jalisco, MexicoDepartamento de Psicología Aplicada, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, 950 Sierra Mojada St., Independencia, 44340, Guadalajara, Jalisco, MexicoSchool of Medicine and Health Sciences, Tecnologico de Monterrey. Canal de Miramontes, Coapa, San Bartolo el Chico, Tlalpan, 14380, Mexico City, MexicoBackground: 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.http://www.sciencedirect.com/science/article/pii/S2451865424001443Internet-Based psychoeducational programBreast healthBreast cancerRandomized controlled trialCancer screeningCancer diagnosis
spellingShingle Reyna Jazmín Martínez-Arriaga
Alejandro Dominguez-Rodriguez
Sergio Osvaldo Meza-Chavolla
Yineth Alejandra Muñoz-Anacona
Adrián Antonio Cisneros-Hernández
Joel Omar González-Cantero
Leivy Patricia González-Ramírez
Paulina Erika Herdoiza-Arroyo
Norma Alicia Ruvalcaba-Romero
Fabiola Macías-Espinoza
Said Jiménez
“Salud Mamaria”, an internet-based psychoeducational program during the breast cancer diagnosis process: Protocol for a randomized controlled trial
Contemporary Clinical Trials Communications
Internet-Based psychoeducational program
Breast health
Breast cancer
Randomized controlled trial
Cancer screening
Cancer diagnosis
title “Salud Mamaria”, an internet-based psychoeducational program during the breast cancer diagnosis process: Protocol for a randomized controlled trial
title_full “Salud Mamaria”, an internet-based psychoeducational program during the breast cancer diagnosis process: Protocol for a randomized controlled trial
title_fullStr “Salud Mamaria”, an internet-based psychoeducational program during the breast cancer diagnosis process: Protocol for a randomized controlled trial
title_full_unstemmed “Salud Mamaria”, an internet-based psychoeducational program during the breast cancer diagnosis process: Protocol for a randomized controlled trial
title_short “Salud Mamaria”, an internet-based psychoeducational program during the breast cancer diagnosis process: Protocol for a randomized controlled trial
title_sort salud mamaria an internet based psychoeducational program during the breast cancer diagnosis process protocol for a randomized controlled trial
topic Internet-Based psychoeducational program
Breast health
Breast cancer
Randomized controlled trial
Cancer screening
Cancer diagnosis
url http://www.sciencedirect.com/science/article/pii/S2451865424001443
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