Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-01-04 @ 5:03 AM
Study NCT ID:
NCT06455657
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Breast Cancer Education to Prisoner Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The study is of a semi-separate type and all women can be trained.'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The study is of a semi-separate type and all women can be trained.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-07', 'studyFirstSubmitDate': '2024-05-23', 'studyFirstSubmitQcDate': '2024-06-07', 'lastUpdatePostDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Breast Cancer Awareness Scale', 'timeFrame': 'first-2. months', 'description': 'It was developed in 2010 by the UK cancer research center, "King\'s College London" and "University College London" to raise breast cancer awareness. In our country, the Turkish validity and reliability study of the scale was conducted by Baş and Ursavaş (2022). The scale consists of a total of 13 items to determine breast cancer awareness, including symptoms (11 items), frequency of breast examination (1 item) and breast cancer age (1 item). The scale has no cut-off point. Answering 5 of the symptoms correctly is coded as 1 point, a 70-year-old woman is coded as 1 point, and breast examination once a month is coded as 1. Incorrect answers are worth 0 points. Scoring is between 0-3. Cronbach\'s alpha value of the scale was found to be 0.89. As the score obtained from the scale increases, breast cancer awareness increases (Baş and Ursavaş, 2022).'}], 'secondaryOutcomes': [{'measure': 'Comprehensive Breast Cancer Knowledge Test', 'timeFrame': 'first- 2. months', 'description': "Comprehensive Breast Cancer Information was developed by Stager in 1993 (Stager, 1993). The scale included a total of 20 knowledge questions. Scale; It is answered as True or False. There were 8 correct and 12 incorrect statements in the questions. The alpha value of the general knowledge dimension was .60; The alpha value of the treatability subscale was found to be .62 and the total of the scale was found to be .71 (Stager, 1993). The scale was adapted to Turkish by Başak (2015). Başak is the sub-dimension and total Cronbach's alpha coefficient of the scale; .65, .50 for General Knowledge, Treatability, and Scale Total scores, respectively. and found .67."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '30621753', 'type': 'BACKGROUND', 'citation': 'Black E, Richmond R. Improving early detection of breast cancer in sub-Saharan Africa: why mammography may not be the way forward. Global Health. 2019 Jan 8;15(1):3. doi: 10.1186/s12992-018-0446-6.'}, {'pmid': '30550371', 'type': 'BACKGROUND', 'citation': "Choi JS, Park M. Factors predicting young women's willingness to conduct vulvar self-examinations in Korea. Health Care Women Int. 2019 Jun;40(6):653-664. doi: 10.1080/07399332.2018.1531003. Epub 2018 Dec 14."}, {'pmid': '22252462', 'type': 'BACKGROUND', 'citation': "Jemal A, Bray F, Forman D, O'Brien M, Ferlay J, Center M, Parkin DM. Cancer burden in Africa and opportunities for prevention. Cancer. 2012 Sep 15;118(18):4372-84. doi: 10.1002/cncr.27410. Epub 2012 Jan 17."}, {'type': 'BACKGROUND', 'citation': 'Mohamed, A. O. A., Nori, M. M. M., & Altamih, R. A. A. (2021). The Effectiveness of Breast Cancer Health Education Campaign and Breast Self-Examination Training among Female Detainees, Khartoum City-Sudan. Journal of Environmental Science and Public Health, 5(2), 296-310'}, {'type': 'BACKGROUND', 'citation': 'Saadeldin A. Idris, Aamir A. Hamza, Mohamed M. Hafiz, Mohammed Eltayeb A. Ali, Gamal E. H. A., El Shallaly Knowledge, attitude and practice of breast self examination among final years female medical students in Sudan. Int J Public Health Res 2013;1:6-10'}, {'type': 'RESULT', 'citation': 'American Cancer Society. Breast Cancer Information & Overview. 2023. Available from: https://www.cancer.org/cancer/types/breast-cancer.html'}, {'type': 'RESULT', 'citation': 'Baş, S., Ursavaş, F.(2022). Meme Kanseri Farkındalık Ölçeğinin Geçerlilik ve Güvenilirliği, Çankırı Karatekin Üniversitesi Sağlık Bilimleri Enstitüsü Hemşirelik Anabilim Dalı, Yüksek Lisans Tezi'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to determine the effect of breast cancer education given to incarcerated women on breast cancer knowledge and awareness.', 'detailedDescription': "Breast cancer is the most common cancer among women in the world, accounting for almost a quarter of cancer cases diagnosed among women, with 1.15 million cases diagnosed each year. Breast cancer is common in both developed and developing countries. However, in developing countries, these rates are three times higher and the mortality rate is quite high. Risk factors include age, low socioeconomic level, early menarche, late menopause, family history of breast disease, long-term use of hormone replacement therapy, breastfeeding status and lifestyle habits.\n\nIt is reported that breast cancer screening programs such as mammography, breast self-examination (BSE) and clinical breast examination (CMM) have an important role in early diagnosis, increasing the survival rate, reducing the death rate and preventing relapse in breast cancer patients. It has been reported that women who perform regular BSE are more likely to have early stages of the disease, this is because regular BSE gives the woman information about the feel and appearance of the breast. Thus, the woman will be able to detect any changes as early as possible. It is reported that the practice of breast self-examination depends on different factors, including women's knowledge, attitude, socio-demographic and sociocultural factors. Other reasons for low implementation rates, such as lack of time, forgetfulness, and low education level, have also been reported.\n\nBreast cancer is the second leading cause of death after cervical cancer among incarcerated women under the age of 40. 27% of women over the age of 40 had breast cancer, and 18% of these women died. It is of great importance to raise awareness, which is considered one of the main elements of secondary prevention in breast cancer."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Volunteering to participate in the study,\n* Being between the ages of 18-65,\n* No history of breast cancer,\n* To know Turkish.\n\nExclusion Criteria:\n\n* Those who do not agree to participate in the study,\n* Having a history of breast cancer,\n* Those who do not speak Turkish'}, 'identificationModule': {'nctId': 'NCT06455657', 'briefTitle': 'Breast Cancer Education to Prisoner Women', 'organization': {'class': 'OTHER', 'fullName': 'Hitit University'}, 'officialTitle': 'The Effect of Breast Cancer Education Given to Prisoner Women on Breast Cancer Knowledge and Awareness', 'orgStudyIdInfo': {'id': 'Hitit_university_1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prisoner women receiving breast cancer training', 'description': 'Questionnaires and scales will be administered to the participants as a pre-test. Breast cancer education will be provided in groups and their feedback will be received. Reminder training will be repeated 1 month after the training. The survey and scales will be administered to the participants as a posttest 1 month after the second training.', 'interventionNames': ['Other: breast cancer education']}], 'interventions': [{'name': 'breast cancer education', 'type': 'OTHER', 'description': 'Questionnaires and scales will be administered to the participants as a pre-test. Breast cancer education will be provided in groups and their feedback will be received. Reminder training will be repeated 1 month after the training. The survey and scales will be administered to the participants as a posttest 1 month after the second training.', 'armGroupLabels': ['Prisoner women receiving breast cancer training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19600', 'city': 'Çorum', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Fatma Yıldırım', 'role': 'CONTACT', 'email': 'fatmadmryldrm@gmail.com', 'phone': '05466742445'}], 'facility': 'L type prison', 'geoPoint': {'lat': 40.54889, 'lon': 34.95333}}, {'city': 'Çorum', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Fatma Yıldırım', 'role': 'CONTACT'}], 'facility': 'Hitit university', 'geoPoint': {'lat': 40.54889, 'lon': 34.95333}}, {'zip': '19600', 'city': 'Çorum', 'state': 'Çorum', 'status': 'NOT_YET_RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Fatma Yıldırım', 'role': 'CONTACT', 'email': 'fatmadmryldrm@gmail.com', 'phone': '05466742445'}], 'facility': 'Fatma Yıldırım', 'geoPoint': {'lat': 40.54889, 'lon': 34.95333}}], 'centralContacts': [{'name': 'Fatma Yıldırım, Dr', 'role': 'CONTACT', 'email': 'fatmadmryldrm@gmail.com', 'phone': '05466742445'}, {'name': 'Fatma Yıldırım, Dr.', 'role': 'CONTACT', 'email': 'fatmadmryldrm@gmail.com', 'phone': '05466742445'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hitit University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Fatma Yildirim', 'investigatorAffiliation': 'Hitit University'}}}}