- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07692464
Visual Breast Self-Examination Education in Illiterate Women
The Effect of Breast Self-Examination Education Using Visual Materials on Breast Cancer Awareness and Health Motivation Among Illiterate Women of Reproductive Age: A Study in Diyarbakır, Türkiye
Breast cancer is the most common malignancy among women and remains a major public health concern despite being largely preventable through early detection and regular screening practices. Increasing early detection rates depends on women's ability to recognize the signs and symptoms of breast cancer, perform regular breast self-examination (BSE), and maintain adequate health motivation. However, women who are illiterate and reside in rural areas generally have low levels of breast cancer awareness, which adversely affects early detection behaviors. This situation is associated with insufficient knowledge, misconceptions, limited access to healthcare services, and low health literacy. Previous studies have demonstrated that educational interventions supported by visual materials are effective in improving health awareness among individuals with low educational attainment. Therefore, this study aims to contribute to the limited literature by evaluating an intervention designed to improve breast cancer awareness among women with low literacy levels.
The study is designed for illiterate women of reproductive age (15-49 years) living in rural areas. Participants will receive breast self-examination (BSE) education using visual materials. The educational content will include breast anatomy, signs and symptoms of breast cancer, the importance of early detection, and the correct steps for performing breast self-examination. Pictures, breast models, videos, and hands-on demonstration techniques will be used throughout the educational sessions. The effectiveness of the intervention will be evaluated using a pretest-posttest design by comparing changes in breast cancer awareness and health motivation before and after the educational program. The research process will include a literature review, development of educational materials, implementation of the intervention, data collection, and statistical analysis, with the principal investigator actively involved in all phases of the study.
The study is expected to improve participants' ability to recognize the signs and symptoms of breast cancer, increase the frequency of breast self-examination, and enhance their health motivation. Furthermore, the findings are expected to support the development of community-based health education skills among midwifery students, encourage their active participation in preventive healthcare services, and strengthen their involvement in scientific research. The results may also provide evidence for planning educational programs targeting women with low educational attainment and contribute to the development of visual material-based educational strategies. Ultimately, the study is anticipated to increase women's awareness of their own health responsibilities, promote early detection behaviors, improve quality of life, and indirectly contribute to reducing breast cancer-related mortality.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Breast cancer remains the most common cancer among women worldwide, and early detection is one of the most effective strategies for reducing mortality. However, women with limited literacy often have lower awareness of breast cancer, inadequate knowledge of breast self-examination (BSE), and reduced motivation to engage in preventive health behaviors. Traditional educational approaches that rely heavily on written information may be insufficient for this population.
This randomized controlled trial has been designed to evaluate the effectiveness of a visual educational intervention developed specifically for illiterate women of reproductive age living in rural areas. The intervention incorporates culturally appropriate visual materials, including illustrated educational brochures, demonstration videos, and a handmade amigurumi breast model to facilitate practical learning of breast self-examination techniques.
Participants allocated to the intervention group will receive structured face-to-face education delivered in three educational sessions. The sessions include information on breast anatomy, warning signs of breast cancer, the importance of early detection, recommended breast cancer screening practices, and step-by-step demonstration of breast self-examination using visual teaching materials. Interactive practice and reinforcement activities are incorporated to improve knowledge retention and skill acquisition.
Participants in the control group will receive routine health services without the structured educational intervention during the study period.
The effectiveness of the intervention will be evaluated by comparing changes in breast cancer awareness and health motivation before and after the intervention using validated measurement instruments. The findings are expected to provide evidence regarding the effectiveness of visual education strategies for improving preventive health behaviors among women with low literacy and may contribute to the development of community-based breast cancer education programs for disadvantaged populations.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
-
Malatya, Turecko (Türkiye)
- İnönü University Faculty of Health Sciences
-
Malatya, Turecko (Türkiye), 44
- İnönü University Faculty of Health Sciences
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Able to communicate verbally No visual or hearing impairment Aged between 15 and 49 years No previously diagnosed chronic diseases (e.g., cardiovascular diseases, asthma, epilepsy, etc.) No history of breast cancer education or breast self-examination (BSE/KKMM) training within the last 21 days Female participants
Exclusion Criteria:
- Currently pregnant or planning pregnancy in the near future Presence of a family history of breast cancer Having any health condition that would prevent participation in the educational intervention
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Intervention Group
Participants will receive a structured visual breast self-examination education program using illustrated educational materials and an amigurumi breast model, in addition to routine care.
|
A structured behavioral education program designed for illiterate women aged 15-49 years to improve breast cancer awareness and breast self-examination (BSE) skills.
The intervention is delivered face-to-face using visual educational materials, pictorial brochures, an amigurumi breast model, and guided hands-on demonstrations.
The program includes repeated teaching sessions and practical applications to reinforce learning and support behavioral change in breast health practices.
Ostatní jména:
|
|
Žádný zásah: Control Group
Participants will receive routine care without the visual breast self-examination education during the study period.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Breast Cancer Awareness Level
Časové okno: Baseline and immediately after the 15-minute intervention session
|
Breast cancer awareness will be assessed using a validated Breast Cancer Awareness Scale.
The scale evaluates participants' knowledge regarding breast cancer symptoms, early detection practices, and screening behaviors.
Higher scores reflect greater levels of breast cancer awareness and knowledge.
|
Baseline and immediately after the 15-minute intervention session
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Health Motivation Level
Časové okno: Baseline and immediately after the 10-15-minute educational intervention session
|
Health motivation will be assessed using the Health Motivation subscale of the Champion Health Belief Model Scale.
This subscale evaluates participants' motivation to engage in preventive health behaviors.
Higher scores indicate greater health motivation.
|
Baseline and immediately after the 10-15-minute educational intervention session
|
Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 8970
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Rakovina prsu
-
Tianjin Medical University Cancer Institute and...Guangxi Medical University; Sun Yat-sen University; Chinese PLA General Hospital a další spolupracovníciDokončenoPrůvodce klinickou aplikací Conebeam Breast CTČína
-
Xijing HospitalAktivní, ne náborRakovina prsu | Rakovina prsu (Triple Negative Breast Cancer (TNBC))Čína
-
Shanghai Henlius BiotechZatím nenabírámeRakovina prsu (Triple Negative Breast Cancer (TNBC))Čína
-
Assistance Publique - Hôpitaux de ParisZatím nenabírámeRakovina prsu (Triple Negative Breast Cancer (TNBC))
-
Gangnam Severance HospitalNáborHER2 Enriched Subtype Cancer Breast, Herzuma, PAM50 StudyKorejská republika
-
BioNTech SESeventh Framework ProgrammeDokončenoRakovina prsu (Triple Negative Breast Cancer (TNBC))Švédsko, Německo
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); National Institutes of Health (NIH); Rising...NáborAnatomický karcinom prsu stadia II AJCC v8 | Anatomický karcinom prsu stadia III AJCC v8 | Rané stadium karcinomu prsu | Anatomic Stage I Breast Cancer American Joint Committee on Cancer (AJCC) v8Spojené státy
-
Emory UniversityNational Cancer Institute (NCI)StaženoPrognostický karcinom prsu stadia IV AJCC v8 | Metastatický maligní novotvar v mozku | Metastatický karcinom prsu | Anatomic Stage IV Breast Cancer American Joint Committee on Cancer (AJCC) v8
-
NRG OncologyNational Cancer Institute (NCI)DokončenoAnatomický karcinom prsu stadia IV AJCC v8 | Prognostický karcinom prsu stadia IV AJCC v8 | Metastatický maligní novotvar v kosti | Metastatický maligní novotvar v lymfatických uzlinách | Metastatický maligní novotvar v játrech | Metastatický karcinom prsu | Metastatický maligní novotvar v plicích | Metastatický... a další podmínkySpojené státy, Kanada, Saudská arábie, Jižní Korea
-
Jessica Mezzanotte SharpeNáborNemalobuněčný karcinom plic | Klasický Hodgkinův lymfom | Spinocelulární karcinom v ústech | Melanom (rakovina kůže) | Rakovina prsu (Triple Negative Breast Cancer (TNBC)) | Invazivní karcinom prsu | Renální buněčný karcinom (rakovina ledvin) | Rakovina konečníku s MSI-H/dMMRSpojené státy