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

NCT05830461 | Unknown

• 1 other identifier: CI-01022
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Breast Cancer

Keywords

Cancer Screening Tests; Anxiety; Depression; Sense of coherence; Psychological Intervention; Internet-Based Intervention

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Change in the scores of the Sense of coherence

  1 month, depends on when the participant finishes the modules.

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

Online psychological care program to reduce psychological distress in women who attend a breast clinic BEHAVIORAL

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.

Experimental group

Psychological care program to reduce psychological distress in women who attend a breast clinic BEHAVIORAL

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with suicidal ideation and/or attempt.

Sponsors & Collaborators

• University of Guadalajara: lead
• Instituto Mexicano del Seguro Social: collaborator
• Tecnologico de Monterrey: collaborator
• Universidad Internacional del Ecuador: collaborator
• University of Twente: collaborator

Study Sites (1)

Instituto Mexicano del Seguro Social

Guadalajara, Jalisco, 44300, Mexico

Location

Related Publications (15)

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  PMID: 6880820 BACKGROUND

• 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.

  PMID: 1641674 BACKGROUND

• Antonovsky A. The structure and properties of the sense of coherence scale. Soc Sci Med. 1993 Mar;36(6):725-33. doi: 10.1016/0277-9536(93)90033-z.

  PMID: 8480217 BACKGROUND

• 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.

  PMID: 21188664 BACKGROUND

• 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.

  PMID: 24150421 BACKGROUND

• 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.

  PMID: 24031131 BACKGROUND

• 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.

  PMID: 15066912 BACKGROUND

• 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.

  PMID: 33854466 BACKGROUND

• 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.

  PMID: 31558323 BACKGROUND

• 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.

  PMID: 27332968 BACKGROUND

• 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.

  PMID: 25833865 BACKGROUND

• 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.

  PMID: 31996235 BACKGROUND

• 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.

  PMID: 18600114 BACKGROUND

• 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.

  PMID: 21039773 BACKGROUND

• Martinez-Arriaga RJ, Dominguez-Rodriguez A, Meza-Chavolla SO, Munoz-Anacona YA, Cisneros-Hernandez AA, Gonzalez-Cantero JO, Gonzalez-Ramirez LP, Herdoiza-Arroyo PE, Ruvalcaba-Romero NA, Macias-Espinoza F, Jimenez S. "Salud Mamaria", an internet-based psychoeducational program during the breast cancer diagnosis process: Protocol for a randomized controlled trial. Contemp Clin Trials Commun. 2024 Nov 26;43:101397. doi: 10.1016/j.conctc.2024.101397. eCollection 2025 Feb.

  PMID: 39802661 DERIVED

Related Links

• Information about breast cancer screening

MeSH Terms

Conditions

Breast Neoplasms; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Reyna J Martínez Arriaga, PhD

  University of Guadalajara

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Central Study Contacts

Reyna J Martínez Arriaga, PhD

CONTACT

+52 1 3311979082; reyna.martinez@academicos.udg.mx

Alejandro Domínguez Rodríguez, PhD

CONTACT

+521 664 471 3277; a.dominguezrodriguez@utwente.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 26, 2023
• Study Start: October 19, 2023
• Primary Completion: May 1, 2024
• Study Completion: August 1, 2024
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)