Breast Cancer-Related Approach for Increasing Cervical Cancer Screening
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Sensitization to Cervical Cancer (CC) screening, Home-based HPV self-sampling.
- Кому может быть актуально
- Состояния в реестре: Cervical Cancer Screening. Базовые параметры: 50 лет — 74 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Швейцария
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Improving Cervical Cancer Screening Coverage Among Underscreened Women Aged 50 to 74 in Switzerland Using HPV Self-sampling Strategies: A Randomized Study - Breast Cancer-Related Approach for Increasing Cervical Cancer Screening
Обзор
The primary objective of this clinical trial is to assess cervical cancer screening participation among under-screened women invited through organized breast cancer screening programs in Switzerland. This randomized trial will compare three arms: 1. Intervention group 1: Sensitization to Cervical Cancer (CC) screening Women will receive an awareness letter explaining the importance of cervical cancer screening, the Swiss recommendations and an invitation to schedule an appointment. 2. Intervention group 2: Home-based Human papillomavirus infection (HPV) self-sampling Women will receive a free-of-charge vaginal self-sampling kit for HPV infection 3. Observational control group Women selected in the control arm will only be recruited one year following the screening of those in the intervention arm (T0+1), as to not influence Cervical Cancer Screening (CCS) behavior during this period by being reminded of screening recommendations.
Подробное описание
Secondary objectives are:
* To identify and compare the association of socio-demographic characteristics with screening participation in all study arms (cf. 3.2 study design). * To compare the use of primary screening methods (HPV test vs. Papanicolaou test) between study arms. * To compare prevalence of positive primary screening and triage results between study arms. * To compare follow-up rates for participants screened positive in both intervention arms. * To evaluate acceptability of both screening strategies (sensitization vs. home-based). * To assess the relationship between CCS behavior and Breast Cancer Screening (BCS) behavior.
Вмешательства
- Поведенческое Sensitization to Cervical Cancer (CC) screening
Women will receive an awareness letter explaining the importance of cervical cancer screening, the Swiss recommendations and an invitation to schedule an appointment. - Поведенческое Home-based HPV self-sampling
Women will receive a free-of-charge vaginal self-sampling kit for HPV infection.
Первичные конечные точки
- Participation to Cervical Cancer Screening (CCS) [Срок оценки: 12 months]
Вторичные конечные точки (7)
- Correlation of socio-demographic characteristics with screening participation [Срок оценки: 12 months]
- Choice of primary screening methods (HPV testing vs cytology) [Срок оценки: 12 months]
- Prevalence of positive primary screening (HPS test) and triage results (cytology) [Срок оценки: 12 months]
- Follow-up rates for participants screened positive [Срок оценки: 12 months]
- Acceptability of screening strategies [Срок оценки: 12 months]
- Reasons for non-compliance [Срок оценки: 12 months]
- Association between Cervical Cancer Screening (CCS) behavior and Breast Cancer Screening (BCS) screening behaviors [Срок оценки: 12 months]
Критерии участия
Критерии включения
- Women receiving Breast Cancer Screening (BCS) invitation letters in the selected five cantons (Geneva, Bern (francophone), Jura, Neuchâtel, and Vaud)
- Aged 50 to 74 years old
- Not been screened for cervical cancer in the past three years
- Speaking one of the 6 languages of the study (French, German, Italian, and in English, Spanish, and Portuguese)
Критерии исключения
- Prior cervical cancer diagnosis,
- Hysterectomy
- Non consent to participate to the study
- Incapable of judgment or under tutelage
- Pregnancy
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Профилактика
Центры проведения
Швейцария · 1 центр
- University Hospitals of Geneva — Geneva
Идентификаторы
NCT: NCT07171658 · 32HW-0_228666