Breast Cancer
Conditions
Keywords
Cancer Screening Tests, Anxiety, Depression, Sense of coherence, Psychological Intervention, Internet-Based Intervention
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.
Interventions
BEHAVIORALOnline 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.
BEHAVIORALPsychological 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
Instituto Mexicano del Seguro Social
Tecnologico de Monterrey
Universidad Internacional del Ecuador
University of Twente
University of Guadalajara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
The patients are not aware that there is an experimental group and a control group, the participants are not related and do not know each other.
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the scores of the Hospital Anxiety and Depression Scale | 1 month, depends on when the participant finishes the modules. | 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. |
| Change in the scores of the Psychological Consequences Questionnaire | 1 month, depends on when the participant finishes the modules. | Evaluates the negative psychological consequences of breast cancer screening. It contemplates three dimensions: Emotional Affects, Physical Affects and Social Affects. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the scores of the Sense of coherence | 1 month, depends on when the participant finishes the modules. | 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. |
Countries
Mexico
Contacts
Primary ContactReyna J Martínez Arriaga, PhD
Backup ContactAlejandro Domínguez Rodríguez, PhD
Outcome results
None listed