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

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2025-02-01 DOI:10.1016/j.conctc.2024.101397

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

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引用次数: 0

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.

查看原文本刊更多论文

“Salud Mamaria”，一个基于网络的乳腺癌诊断过程中的心理教育项目：随机对照试验方案。

背景：乳腺癌诊断过程中的一些关键挑战包括缺乏信息和负面心理后果，例如对该过程的痛苦和焦虑。在诊断过程中实施心理教育方案可以提高妇女的幸福感。“Salud Mamaria”是一个基于互联网的心理教育计划（IBPP），包括三个干预措施：A（“改善你的健康习惯和自我保健”），B（“等待你的活检结果”）和C（“在你的乳腺癌诊断后支持你”）。目的：1)评估三种干预措施（A、B和C）后研究变量的变化；2)评估IBPP组与积极对照组之间研究变量的差异。方法：本试验为优势试验，采用两组独立的实验设计：实验组和积极对照组。所有参与者将被随机分配到两种情况中的一种。焦虑症状、后果阴性筛查、连贯性、干预满意度和系统可用性将被测量。根据患者的临床情况，将患者分为未怀疑癌症(A)、怀疑癌症(B)和确诊癌症(C)三组。在每次干预前后，通过在线平台进行问卷调查。结论：在乳腺癌筛查和诊断过程中实施心理教育计划可以促进妇女的健康和福祉。它还可以鼓励遵守医疗筛查建议，减轻信息的缺乏，并减少相关的痛苦。试验注册：ClinicalTrials.gov NCT05830461。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.