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

Breast Cancer Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05830461
• Other study ID #: CI-01022
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 19, 2023
• Est. completion date: August 2024

Study information

• Verified date: June 2023
• Source: University of Guadalajara
• Contact: Reyna J Martínez Arriaga, PhD
• Phone: +52 1 3311979082
• Email: reyna.martinez[@]academicos.udg.mx
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: August 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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.
• 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.

Locations

Country	Name	City	State
Mexico	Instituto Mexicano del Seguro Social	Guadalajara	Jalisco

Sponsors (5)

Lead Sponsor	Collaborator
University of Guadalajara	Instituto Mexicano del Seguro Social, Tecnologico de Monterrey, Universidad Internacional del Ecuador, University of Twente

Country where clinical trial is conducted

Mexico, 

References & Publications (14)

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Brandon CJ, Mullan PB. Patients' perception of care during image-guided breast biopsy in a rural community breast center: communication matters. J Cancer Educ. 2011 Mar;26(1):156-60. doi: 10.1007/s13187-010-0178-7. — View Citation

Castaneda SF, Malcarne VL, Foster-Fishman PG, Davidson WS, Mumman MK, Riley N, Sadler GR. Health care access and breast cancer screening among Latinas along the California-Mexican border. J Immigr Minor Health. 2014 Aug;16(4):670-81. doi: 10.1007/s10903-013-9938-x. — View Citation

Chujo M, Kigawa J, Okamura H. Psychological Factors and Characteristics of Recurrent Breast Cancer Patients with or without Psychosocial Group Therapy Intervention. Yonago Acta Med. 2011 Dec;54(4):65-74. Epub 2011 Dec 1. — View Citation

Cockburn J, De Luise T, Hurley S, Clover K. Development and validation of the PCQ: a questionnaire to measure the psychological consequences of screening mammography. Soc Sci Med. 1992 May;34(10):1129-34. doi: 10.1016/0277-9536(92)90286-y. — View Citation

Consedine NS, Magai C, Krivoshekova YS, Ryzewicz L, Neugut AI. Fear, anxiety, worry, and breast cancer screening behavior: a critical review. Cancer Epidemiol Biomarkers Prev. 2004 Apr;13(4):501-10. — View Citation

Dominguez-Rodriguez A, Martinez-Luna SC, Hernandez Jimenez MJ, De La Rosa-Gomez A, Arenas-Landgrave P, Esquivel Santovena EE, Arzola-Sanchez C, Alvarez Silva J, Solis Nicolas AM, Colmenero Guadian AM, Ramirez-Martinez FR, Vargas ROC. A Self-Applied Multi-Component Psychological Online Intervention Based on UX, for the Prevention of Complicated Grief Disorder in the Mexican Population During the COVID-19 Outbreak: Protocol of a Randomized Clinical Trial. Front Psychol. 2021 Mar 29;12:644782. doi: 10.3389/fpsyg.2021.644782. eCollection 2021. — View Citation

Fang SY, Wang YL, Lu WH, Lee KT, Kuo YL, Fetzer SJ. Long-term effectiveness of an E-based survivorship care plan for breast cancer survivors: A quasi-experimental study. Patient Educ Couns. 2020 Mar;103(3):549-555. doi: 10.1016/j.pec.2019.09.012. Epub 2019 Sep 12. — View Citation

Galiano-Castillo N, Cantarero-Villanueva I, Fernandez-Lao C, Ariza-Garcia A, Diaz-Rodriguez L, Del-Moral-Avila R, Arroyo-Morales M. Telehealth system: A randomized controlled trial evaluating the impact of an internet-based exercise intervention on quality of life, pain, muscle strength, and fatigue in breast cancer survivors. Cancer. 2016 Oct 15;122(20):3166-3174. doi: 10.1002/cncr.30172. Epub 2016 Jun 22. — View Citation

Hollis C, Morriss R, Martin J, Amani S, Cotton R, Denis M, Lewis S. Technological innovations in mental healthcare: harnessing the digital revolution. Br J Psychiatry. 2015 Apr;206(4):263-5. doi: 10.1192/bjp.bp.113.142612. — View Citation

Holtdirk F, Mehnert A, Weiss M, Meyer B, Watzl C. Protocol for the Optimune trial: a randomized controlled trial evaluating a novel Internet intervention for breast cancer survivors. Trials. 2020 Jan 29;21(1):117. doi: 10.1186/s13063-019-3987-y. — View Citation

Liao MN, Chen MF, Chen SC, Chen PL. Uncertainty and anxiety during the diagnostic period for women with suspected breast cancer. Cancer Nurs. 2008 Jul-Aug;31(4):274-83. doi: 10.1097/01.NCC.0000305744.64452.fe. — View Citation

Montgomery M, McCrone SH. Psychological distress associated with the diagnostic phase for suspected breast cancer: systematic review. J Adv Nurs. 2010 Nov;66(11):2372-90. doi: 10.1111/j.1365-2648.2010.05439.x. — View Citation

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* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.

External Links

•   Information about breast cancer screening