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Набор скоро начнётся NCT07642531

A Modular Cloud Platform For Fertility Preservation

Без фазы С лечением Fertility Preservation Gynecologic Cancers

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: Developing a Modular Cloud-Based Platform to guide decision-making in fertility preservation.
Кому может быть актуально
Состояния в реестре: Fertility Preservation, Gynecologic Cancers. Базовые параметры: 18 лет — 45 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
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

A Modular CLoud Based Platform To Enhance Fertility Preservation Awareness: Design, Pilot Testing And Randomized Controlled Trial

Обзор

The research was designed as a randomized controlled study to determine the effectiveness of a modular cloud-based training platform in increasing awareness of fertility preservation. The study aims to develop a free, modular, cloud-based, sustainable digital platform to increase fertility awareness. The platform will provide basic information on fertility preservation methods in plain language to support informed decisions. Content will be based on European Society of Human Reproduction and Embryology (ESHRE) , International Federation of Gynaecology and Obstetrics (FIGO) and Asian Society of Gynecologic Oncology (ASCO) guidelines. The study targets not only cancer patients but also women requesting fertility preservation for medical or social reasons. In the first stage, the platform will be designed with the ADDIE instructional design model (Analysis, Design, Development, Implementation, Evaluation) and content created per international guidelines. In the second stage, the prototype will be pilot-tested and revised. In the third stage, effectiveness will be tested through a randomized controlled trial. Educational modules will be provided to the intervention group, while the control group will receive brochures. The study will include women aged 18-45 with early-stage gynecological cancer (cervix, ovary, tube, endometrium) at Prof. Dr. Cemil Tascioglu City Hospital, untreated. Participants must have Turkish literacy and internet access. Sample size, calculated with G\*Power, is 140 total (70 per group).

Подробное описание

This is a randomized controlled experimental study. The research was carried out in the Prof. Dr. Cemil Tascioglu City Hospital.

Вмешательства

  • Другое Developing a Modular Cloud-Based Platform to guide decision-making in fertility preservation
    In this study, a modular cloud-based platform will be developed to raise awareness about fertility preservation.

Первичные конечные точки

  • Awareness rates regarding fertility preservation options among patients in the experimental and control groups [Срок оценки: Change from beginning of the study and after 3 weeks of after the mobile application is given]
  • fertility preservation knowledge scores [Срок оценки: Change from beginning of the study and after 3 weeks of after the mobile application is given]
  • fertility preservation attitude scores [Срок оценки: Change from beginning of the study and after 3 weeks of after the mobile application is given]
  • Acceptance of fertility preservation [Срок оценки: Change from beginning of the study and after 3 weeks of after the mobile application is given]

Критерии участия

Критерии включения

  • Women of reproductive age between the ages of 18 and 45,
  • Diagnosed with early stage cervical cancer, ovarian cancer, tubal cancer and endometrial cancer and whose treatment has not started,
  • Those who have a smartphone and can use the platform,
  • Volunteering and giving informed consent,
  • Turkish literate,
  • Individuals who do not report mental problems
  • Do not have children,
  • Marital status is married or single.

Критерии исключения

  • Neurological disease (e.g., stroke, multiple sclerosis) or cognitive impairment,
  • Advanced-stage gynecologic cancers,
  • Failure to complete the follow-up period,
  • Initiation of oncologic treatment during the study period,
  • Non-completion or incomplete completion of the data collection instruments,
  • Non-use of the platform among participants allocated to the intervention group,
  • History of prior cancer treatment.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Turkey (Türkiye) · 1 центр
  • Biruni University — Istanbul

Идентификаторы

NCT: NCT07642531 · KAD-FR-42

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗