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

June 29, 2023 updated by: Reyna Jazmin Martinez Arriaga, University of Guadalajara

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.

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44300
        • Instituto Mexicano del Seguro Social
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental group
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

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.
Active Comparator: Control group
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

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in the scores of the Hospital Anxiety and Depression Scale
Time Frame: 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.
1 month, depends on when the participant finishes the modules.
Change in the scores of the Psychological Consequences Questionnaire
Time Frame: 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.
1 month, depends on when the participant finishes the modules.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in the scores of the Sense of coherence
Time Frame: 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.
1 month, depends on when the participant finishes the modules.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Guadalajara

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Instituto Mexicano del Seguro Social
Universidad Internacional del Ecuador
University of Twente
Tecnologico de Monterrey

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Reyna J Martínez Arriaga, PhD, University of Guadalajara
  • Study Chair: Alejandro Domínguez Rodríguez, PhD, University of Twente
  • Study Chair: Sergio O Meza Chavolla, MD, Instituto Mexicano del Seguro Social
  • Study Chair: Fabiola Macías Espinoza, PhD, University of Guadalajara
  • Study Chair: Joel O González Cantero, PhD, University of Guadalajara
  • Study Chair: Leivy P González Ramírez, PhD, Tecnologico de Monterrey
  • Study Chair: Paulina Herdoiza Arroyo, PhD, Universidad Internacional del Ecuador
  • Study Chair: Yineth A Muñoz Anacona, BD, University of Guadalajara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 19, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 26, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CI-01022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The participants will be recruited in a public health institution. Since it is a government institution, one of the rules regarding the information collected is that it cannot be shared with other people or institutions outside the institution.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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