Ignite Creation Date:
2025-12-24 @ 12:03 PM
Ignite Modification Date:
2025-12-27 @ 9:28 PM
Study NCT ID:
NCT05830461
Status:
UNKNOWN
Last Update Posted:
2023-07-03
First Post:
2023-03-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Online Psychological Care Program for Women Who Attend a Breast Clinic.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-21', 'size': 138705, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-04-13T15:46', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': '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.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-10-19', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-29', 'studyFirstSubmitDate': '2023-03-21', 'studyFirstSubmitQcDate': '2023-04-13', 'lastUpdatePostDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the scores of the Hospital Anxiety and Depression Scale', 'timeFrame': '1 month, depends on when the participant finishes the modules.', 'description': '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.'}, {'measure': 'Change in the scores of the Psychological Consequences Questionnaire', 'timeFrame': '1 month, depends on when the participant finishes the modules.', 'description': 'Evaluates the negative psychological consequences of breast cancer screening. It contemplates three dimensions: Emotional Affects, Physical Affects and Social Affects.'}], 'secondaryOutcomes': [{'measure': 'Change in the scores of the Sense of coherence', 'timeFrame': '1 month, depends on when the participant finishes the modules.', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer Screening Tests', 'Anxiety', 'Depression', 'Sense of coherence', 'Psychological Intervention', 'Internet-Based Intervention'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '6880820', 'type': 'BACKGROUND', 'citation': 'Zigmond 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': '1641674', 'type': 'BACKGROUND', '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.'}, {'pmid': '8480217', 'type': 'BACKGROUND', 'citation': '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': '21188664', 'type': 'BACKGROUND', 'citation': "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': '24150421', 'type': 'BACKGROUND', '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.'}, {'pmid': '24031131', 'type': 'BACKGROUND', '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.'}, {'pmid': '15066912', 'type': 'BACKGROUND', '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.'}, {'pmid': '33854466', 'type': 'BACKGROUND', '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.'}, {'pmid': '31558323', 'type': 'BACKGROUND', '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.'}, {'pmid': '27332968', 'type': 'BACKGROUND', '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.'}, {'pmid': '25833865', 'type': 'BACKGROUND', '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.'}, {'pmid': '31996235', 'type': 'BACKGROUND', '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.'}, {'pmid': '18600114', 'type': 'BACKGROUND', '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.'}, {'pmid': '21039773', 'type': 'BACKGROUND', '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.'}, {'pmid': '39802661', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://www.cancer.gov/espanol/tipos/seno/paciente/deteccion-seno-pdq', 'label': 'Information about breast cancer screening'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThere 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).', 'detailedDescription': '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.\n\nIn 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.\n\nIn the intervention there will be two groups: a) experimental group and b) control group.\n\nThe 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.\n\nAll 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of legal age who attend a health institution for screening studies and/or diagnostic evaluation of breast cancer.\n* Patients who can use an electronic device (smart phone, computer, laptop, tablet) to access the virtual platform.\n* Patients who give their informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Patients with suicidal ideation and/or attempt.'}, 'identificationModule': {'nctId': 'NCT05830461', 'briefTitle': 'Online Psychological Care Program for Women Who Attend a Breast Clinic.', 'organization': {'class': 'OTHER', 'fullName': 'University of Guadalajara'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'CI-01022'}}, 'armsInterventionsModule': {'armGroups': [{'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']}], 'interventions': [{'name': 'Online psychological care program to reduce psychological distress in women who attend a breast clinic', 'type': 'BEHAVIORAL', '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).\n\nStage 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.\n\nPsychological techniques based on the cognitive behavioral model, mindfulness, acceptance and commitment therapy, and health beliefs are included.", 'armGroupLabels': ['Experimental group']}, {'name': 'Psychological care program to reduce psychological distress in women who attend a breast clinic', 'type': 'BEHAVIORAL', '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).\n\nStage 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.\n\nPsychological techniques based on the cognitive behavioral model, mindfulness, acceptance and commitment therapy, and health beliefs are included.", 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44300', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'contacts': [{'name': 'Sergio O Meza Chavolla, MD', 'role': 'CONTACT', 'email': 'sergio.mezac@imss.gob.mx', 'phone': '+52 1 33 3168 8948'}], 'facility': 'Instituto Mexicano del Seguro Social', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}], 'centralContacts': [{'name': 'Reyna J Martínez Arriaga, PhD', 'role': 'CONTACT', 'email': 'reyna.martinez@academicos.udg.mx', 'phone': '+52 1 3311979082'}, {'name': 'Alejandro Domínguez Rodríguez, PhD', 'role': 'CONTACT', 'email': 'a.dominguezrodriguez@utwente.nl', 'phone': '+521 664 471 3277'}], 'overallOfficials': [{'name': 'Reyna J Martínez Arriaga, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Guadalajara'}, {'name': 'Alejandro Domínguez Rodríguez, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Twente'}, {'name': 'Sergio O Meza Chavolla, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Instituto Mexicano del Seguro Social'}, {'name': 'Fabiola Macías Espinoza, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Guadalajara'}, {'name': 'Joel O González Cantero, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Guadalajara'}, {'name': 'Leivy P González Ramírez, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Tecnologico de Monterrey'}, {'name': 'Paulina Herdoiza Arroyo, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Universidad Internacional del Ecuador'}, {'name': 'Yineth A Muñoz Anacona, BD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Guadalajara'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Guadalajara', 'class': 'OTHER'}, 'collaborators': [{'name': 'Instituto Mexicano del Seguro Social', 'class': 'OTHER_GOV'}, {'name': 'Tecnologico de Monterrey', 'class': 'OTHER'}, {'name': 'Universidad Internacional del Ecuador', 'class': 'OTHER'}, {'name': 'University of Twente', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Reyna Jazmin Martinez Arriaga', 'investigatorAffiliation': 'University of Guadalajara'}}}}