Online Psychological Care Program for Women Who Attend a Breast Clinic.

NCT05830461 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-07-03

No results posted yet for this study

Summary

The objective of this study is to evaluate the effectiveness of an online psychological care program to reduce anxiety, depression and negative psychological consequences and to increase a sense of coherence in the process of diagnostic evaluation and/or screening of mammary glands in women who attend a breast clinic.

There will be an experimental group and a control group. The experimental group will receive the psychological intervention through a virtual platform and the control group will be given visual material with the information. This platform will be designed based on the principles of user experience (UX).

Conditions

Interventions

BEHAVIORAL

Online psychological care program to reduce psychological distress in women who attend a breast clinic

The intervention will be online and self-applied. It will consist of 3 stages, according to the patient's situation: 1) without suspicion of cancer (A1), 2) with suspicion of cancer (A2), and 3) with confirmed diagnosis of cancer (B). Stage 1 includes modules related to the prevention and timely detection of breast cancer. Stage A2 consists of emotional management in the face of suspicion of breast cancer. In stage B, medical information about breast cancer is provided, as well as psychological strategies to face the diagnosis. Psychological techniques based on the cognitive behavioral model, mindfulness, acceptance and commitment therapy, and health beliefs are included.

BEHAVIORAL

Psychological care program to reduce psychological distress in women who attend a breast clinic

The intervention will be delivered through printed materials. It will consist of 3 stages, according to the patient's situation: 1) without suspicion of cancer (A1), 2) with suspicion of cancer (A2), and 3) with confirmed diagnosis of cancer (B). Stage 1 includes modules related to the prevention and timely detection of breast cancer. Stage A2 consists of emotional management in the face of suspicion of breast cancer. In stage B, medical information about breast cancer is provided, as well as psychological strategies to face the diagnosis. Psychological techniques based on the cognitive behavioral model, mindfulness, acceptance and commitment therapy, and health beliefs are included.

Sponsors & Collaborators

  • Instituto Mexicano del Seguro Social

    collaborator OTHER_GOV
  • Tecnologico de Monterrey

    collaborator OTHER
  • Universidad Internacional del Ecuador

    collaborator OTHER
  • University of Twente

    collaborator OTHER
  • University of Guadalajara

    lead OTHER

Principal Investigators

  • Reyna J Martínez Arriaga, PhD · University of Guadalajara

  • Alejandro Domínguez Rodríguez, PhD · University of Twente

  • Sergio O Meza Chavolla, MD · Instituto Mexicano del Seguro Social

  • Fabiola Macías Espinoza, PhD · University of Guadalajara

  • Joel O González Cantero, PhD · University of Guadalajara

  • Leivy P González Ramírez, PhD · Tecnologico de Monterrey

  • Paulina Herdoiza Arroyo, PhD · Universidad Internacional del Ecuador

  • Yineth A Muñoz Anacona, BD · University of Guadalajara

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-19
Primary Completion
2024-05-31
Completion
2024-08-31

Countries

  • Mexico

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05830461 on ClinicalTrials.gov