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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Breast Cancer

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>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. | Behavioral: Online psychological care program to reduce psychological distress in women who attend a breast clinic<br>* 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.<br>|
| Active Comparator: Control group<br>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. | Behavioral: Psychological care program to reduce psychological distress in women who attend a breast clinic<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the scores of the Hospital Anxiety and Depression Scale | This is an instrument that comprises 14 items: seven to measure anxiety and seven to measure depression experienced in the previous week. The Hospital Anxiety and Depression Scale was validated in Mexican population with a reliability of 0.81 for anxiety and 0.82 for depression. Anxiety items evaluate whether the person has been worried or has experienced sensations of fear, while depression items evaluate anhedonia or pessimistic thoughts. | 1 month, depends on when the participant finishes the modules. | 
| Change in the scores of the Psychological Consequences Questionnaire | Evaluates the negative psychological consequences of breast cancer screening. It contemplates three dimensions: Emotional Affects, Physical Affects and Social Affects. | 1 month, depends on when the participant finishes the modules. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the scores of the Sense of coherence | Evaluates coping with stressors in the illness-well-being continuum and possible solutions to the conflict. It contemplates three dimensions: understandability, manageability and significance. Reliability tests showed a Cronbach´s alpha of .80 overall scale in latin populations. | 1 month, depends on when the participant finishes the modules. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer Screening Tests, Anxiety, Depression, Sense of coherence, Psychological Intervention, Internet-Based Intervention