- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07755163
Screening Cancer Readiness Through Education and Empowerment for Newcomer Women (SCREEN)
The Effect of Online Education on Knowledge and Attitudes Toward Cancer Screening Among Migrant Women: A Randomized Controlled Trial
Purpose: This study was conducted to determine the effect of an online educational intervention on migrant women's knowledge and attitudes toward cancer screening.
DesigN:This study was designed as a two-arm, parallel-group, randomized controlled trial with pre-test and post-test assessments.
Method: The study population will consist of women registered at the Cancer Early Diagnosis, Screening and Training Center (KETEM) affiliated with the Erzincan Provincial Health Directorate. The sample size was calculated based on a two-group (intervention and control) and two-measurement (pre-test and post-test) study design. Using repeated-measures ANOVA with a medium effect size (d = 0.25), a significance level of 5% (α = 0.05), and a statistical power of 80% (1 - β = 0.80), the required sample size was determined to be 34 participants per group (34 in the intervention group and 34 in the control group), resulting in a minimum total sample of 68 participants. To account for potential attrition, it was planned to recruit 80 participants (approximately 20% more than the minimum required sample size).
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ezgi Demirtürk Selçuk, PhD
- Número de teléfono: +905448502161
- Correo electrónico: demirturkezgi@gmail.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
Women aged 30-70 years. Able to read and write. Able to speak and understand Turkish. Have access to the internet at home or in the workplace. Own a smartphone or have access to a smartphone belonging to a family member that can be used by the participant.
Have no hearing, visual, cognitive, or orthopedic impairments that would prevent participation in the study.
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Exclusion Criteria:Presence of cognitive, visual, or orthopedic impairment that may interfere with participation in the study.
Diagnosis of a psychiatric disorder.
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Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: grupo de control
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Women assigned to the control group who are registered at the Cancer Early Diagnosis, Screening and Training Center (KETEM) will be contacted and invited to participate in the study.
During the initial meeting, written informed consent will be obtained, after which the Personal Information Form and study questionnaires will be administered to collect baseline (pre-test) data.
An appointment for the follow-up assessment will be scheduled approximately four weeks later.
Five weeks after the baseline assessment, participants will be contacted by telephone to complete the post-test assessment.
No educational intervention will be provided to the control group during the study period.
After completion of the post-test assessment, participants in the control group will be offered the same cancer screening education program in accordance with the ethical principle of equity.
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Experimental: SCREEN
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Women assigned to the intervention group will be contacted by telephone using the contact information registered at the Cancer Early Diagnosis, Screening and Training Center (KETEM).
For participants without a registered telephone number, home visits will be conducted using the addresses recorded in the KETEM database.
Following completion of the baseline (pre-test) assessment, participants in the intervention group will receive an online cancer screening education program developed in accordance with the Turkish National Cancer Control Program of the General Directorate of Public Health, Ministry of Health of the Republic of Türkiye.
The educational intervention will be delivered in three online sessions via WhatsApp video calls.
During each session, participants will have the opportunity to ask questions, which will be answered by the researcher.
Prior to each session, reminder text messages will be sent to participants' mobile phones to notify them of the date and time of the schede
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Cancer Screening Knowledge Scale
Periodo de tiempo: From baseline to 5 weeks after baseline
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The Cancer Screening Knowledge Scale is a 25-item questionnaire designed to assess participants' knowledge regarding cancer screening.
Total scores range from 0 to 25, with higher scores indicating greater knowledge.
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From baseline to 5 weeks after baseline
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Cancer Screening Attitude Scale-Short Form
Periodo de tiempo: From baseline to 5 weeks after baseline
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The Cancer Screening Attitude Scale-Short Form is a 15-item questionnaire used to assess participants' attitudes toward cancer screening.
Total scores range from 15 to 75, with higher scores indicating more positive attitudes toward cancer screening.
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From baseline to 5 weeks after baseline
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 0413
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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