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Trial Title:
Online Psychological Care Program for Women Who Attend a Breast Clinic.
NCT ID:
NCT05830461
Condition:
Breast Cancer
Conditions: Keywords:
Cancer Screening Tests
Anxiety
Depression
Sense of coherence
Psychological Intervention
Internet-Based Intervention
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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
Masking:
Single (Participant)
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:
Intervention type:
Behavioral
Intervention name:
Online psychological care program to reduce psychological distress in women who attend a breast clinic
Description:
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.
Arm group label:
Experimental group
Intervention type:
Behavioral
Intervention name:
Psychological care program to reduce psychological distress in women who attend a breast clinic
Description:
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.
Arm group label:
Control group
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.
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Instituto Mexicano del Seguro Social
Address:
City:
Guadalajara
Zip:
44300
Country:
Mexico
Contact:
Last name:
Sergio O Meza Chavolla, MD
Phone:
+52 1 33 3168 8948
Email:
sergio.mezac@imss.gob.mx
Start date:
October 19, 2023
Completion date:
August 2024
Lead sponsor:
Agency:
University of Guadalajara
Agency class:
Other
Collaborator:
Agency:
Instituto Mexicano del Seguro Social
Agency class:
Other
Collaborator:
Agency:
Tecnologico de Monterrey
Agency class:
Other
Collaborator:
Agency:
Universidad Internacional del Ecuador
Agency class:
Other
Collaborator:
Agency:
University of Twente
Agency class:
Other
Source:
University of Guadalajara
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05830461
https://www.cancer.gov/espanol/tipos/seno/paciente/deteccion-seno-pdq
