A Modular CLoud Based Platform To Enhance Fertility Preservation Awareness: Design, Pilot Testing And Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- fertility preservation knowledge scores
研究概览
简要总结
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).
详细描述
This is a randomized controlled experimental study. The research was carried out in the Prof. Dr. Cemil Tascioglu City Hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
fertility preservation knowledge scores
时间窗: Change from beginning of the study and after 3 weeks of after the mobile application is given
The Fertility Health Knowledge Scale was developed to evaluate individuals' level of knowledge about fertility health; The Turkish validity and reliability study of the scale was conducted. In this study, the knowledge level of the participants regarding fertility/fertility preservation will be evaluated based on the knowledge score using the scale in question.
fertility preservation attitude scores
时间窗: Change from beginning of the study and after 3 weeks of after the mobile application is given
The Attitudes Toward Fertility and Childbearing Scale was developed to evaluate the attitudes of women who have not yet become mothers towards fertility and childbearing. The Turkish validity and reliability study of the scale was conducted. In this study, participants' attitude scores (sub-dimensions and total attitude level) towards fertility and childbearing will be evaluated using the scale in question.
次要结局
未报告次要终点
研究者
Nezihe KIZILKAYA BEJI
Professor
Biruni University