Clinical trial NCT05830461: 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: Cancer Screening Tests
Anxiety
Depression
Sense of coherence
Psychological Intervention
Internet-Based Intervention
Lead sponsor: University of Guadalajara
Sponsor class: OTHER
Collaborators: name: Instituto Mexicano del Seguro Social
name: Tecnologico de Monterrey
name: Universidad Internacional del Ecuador
name: University of Twente
First posted: 2023-04-26
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study has two arms, one is the experimental group that will receive the treatment through the online platform only, and the other is the comparison group that will receive the treatment delivered through printed visual material. The program consists of three stages that are aimed at: 1) Patients who undergo screening and obtain negative results for malignancy, 2) patients with suspicion and undergo a biopsy, 3) Patients with positive results for breast cancer.
Primary purpose: SUPPORTIVE_CARE

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 criteria: Inclusion Criteria:

* Patients of legal age who attend a health institution for screening studies and/or diagnostic evaluation of breast cancer.
* Patients who can use an electronic device (smart phone, computer, laptop, tablet) to access the virtual platform.
* Patients who give their informed consent to participate in the study.

Exclusion Criteria:

* Patients with suicidal ideation and/or attempt.

Primary outcomes:
measure: Change in the scores of the Hospital Anxiety and Depression Scale
timeFrame: 1 month, depends on when the participant finishes the modules.
measure: Change in the scores of the Psychological Consequences Questionnaire
timeFrame: 1 month, depends on when the participant finishes the modules.
Secondary outcomes:
measure: Change in the scores of the Sense of coherence
timeFrame: 1 month, depends on when the participant finishes the modules.
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Instituto Mexicano del Seguro Social
state: Jalisco
Study officials:
affiliation: University of Guadalajara
name: Reyna J Martínez Arriaga, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Twente
name: Alejandro Domínguez Rodríguez, PhD
role: STUDY_CHAIR
affiliation: Instituto Mexicano del Seguro Social
name: Sergio O Meza Chavolla, MD
role: STUDY_CHAIR
affiliation: University of Guadalajara
name: Fabiola Macías Espinoza, PhD
role: STUDY_CHAIR
affiliation: University of Guadalajara
name: Joel O González Cantero, PhD
role: STUDY_CHAIR
affiliation: Tecnologico de Monterrey
name: Leivy P González Ramírez, PhD
role: STUDY_CHAIR
affiliation: Universidad Internacional del Ecuador
name: Paulina Herdoiza Arroyo, PhD
role: STUDY_CHAIR
affiliation: University of Guadalajara
name: Yineth A Muñoz Anacona, BD
role: STUDY_CHAIR
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