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

University of Guadalajara

Status: Not yet enrolling

Conditions: Breast Cancer

Treatments: Behavioral: Online psychological care program to reduce psychological distress in women who attend a breast clinic; Behavioral: Psychological care program to reduce psychological distress in women who attend a breast clinic

Study type: Interventional

Funder types: Other

Identifiers

NCT05830461

CI-01022

Details and patient eligibility

About

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).

Full 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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Experimental group

Experimental group

Description:

The experimental group will receive the self-applied intervention through a digital platform. The intervention consists of three stages, depending on the situation of the patient: 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.

Treatment:

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

Control group

Active Comparator group

Description:

The experimental group will receive the self-applied intervention through written visual material that will be given to them. The content of the material will be the same as the experimental group.

Treatment:

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