Clinical trial · Interventional
Online Psychological Care Program for Women Who Attend a Breast Clinic.
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.
NCT05830461CI-TRIAL-00067710unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Online psychological care program to reduce psychological distress in women who attend a breast clinic | Behavioral | — | UNRESOLVED |
| Psychological care program to reduce psychological distress in women who attend a breast clinic | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental group
- description
- 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.
- interventionNames
- Behavioral: Online psychological care program to reduce psychological distress in women who attend a breast clinic
- type
- ACTIVE_COMPARATOR
- label
- Control group
- description
- 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.
- interventionNames
- Behavioral: Psychological care program to reduce psychological distress in women who attend a breast clinic
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (15)
- BACKGROUNDZigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x. PMID 6880820
- BACKGROUNDCockburn 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
- BACKGROUNDAntonovsky 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
- BACKGROUNDBrandon 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
- BACKGROUNDCastaneda 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
- BACKGROUNDChujo 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
- BACKGROUNDConsedine 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
- BACKGROUNDDominguez-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.