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Spots Global Cancer Trial Database for Online Psychological Care Program for Women Who Attend a Breast Clinic.

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Trial Identification

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

Official Title: Online Psychological Care Program to Reduce Psychological Distress in the Process of Diagnostic Evaluation and/or Screening of Mammary Glands in Women Who Attend a Breast Clinic.

Study ID: NCT05830461

Conditions

Breast Cancer

Study Description

Brief 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).

Detailed Description: It has been shown that women who undergo diagnostic tests or screening of their mammary glands present symptoms associated with anxiety, concerns regarding a possible positive result for malignancy, as well as emotional distress. It is important to generate psychological programs aimed at reducing the psychological consequences of the diagnostic evaluation and/or screening of mammary glands because there are few approaches on the subject. In Mexico there are breast clinics of the Mexican Social Security Institute, designed to perform screening tests and diagnostic evaluation of mammary glands, with the aim of identifying cases of breast cancer in early stages. However, few psychological interventions have been reported during the diagnostic process, so it is important to know the psychological affectations presented by women who undergo these tests. Given this, this intervention has the objective of evaluating the effectiveness of an online psychological care program to reduce psychological distress and increase the sense of coherence in the process of diagnostic evaluation of mammary glands in women who attend a breast clinic. In the intervention there will be two groups: a) experimental group and b) control group. The experimental group will receive online psychological care through the virtual platform and the patients in the control group will be given visual material with the information. All participants will be invited to attend the breast clinic and undergo screening studies and/or diagnostic evaluation. For the assignment of the experimental and control group, it will be carried out through a randomization process through the Excel program.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: Yes

Locations

Instituto Mexicano del Seguro Social, Guadalajara, Jalisco, Mexico

Contact Details

Name: Reyna J Martínez Arriaga, PhD

Affiliation: University of Guadalajara

Role: PRINCIPAL_INVESTIGATOR

Name: Alejandro Domínguez Rodríguez, PhD

Affiliation: University of Twente

Role: STUDY_CHAIR

Name: Sergio O Meza Chavolla, MD

Affiliation: Instituto Mexicano del Seguro Social

Role: STUDY_CHAIR

Name: Fabiola Macías Espinoza, PhD

Affiliation: University of Guadalajara

Role: STUDY_CHAIR

Name: Joel O González Cantero, PhD

Affiliation: University of Guadalajara

Role: STUDY_CHAIR

Name: Leivy P González Ramírez, PhD

Affiliation: Tecnologico de Monterrey

Role: STUDY_CHAIR

Name: Paulina Herdoiza Arroyo, PhD

Affiliation: Universidad Internacional del Ecuador

Role: STUDY_CHAIR

Name: Yineth A Muñoz Anacona, BD

Affiliation: University of Guadalajara

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

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