A Modular Cloud Platform For Fertility Preservation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorBiruni University
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
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,
Trial design
Design model
Parallel
Treatments tested in this trial
Developing a Modular Cloud-Based Platform to guide decision-making in fertility preservation
Other interventionIn this study, a modular cloud-based platform will be developed to raise awareness about fertility preservation.
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Control- Routine informationNo intervention 0 interventions
Group B: İntervention- Using the educational platformExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Awareness rates regarding fertility preservation options among patients in the experimental and control groups
These data will be obtained through the answers given to the "Awareness status questionnaire for fertility protection".
Time frame
Change from beginning of the study and after 3 weeks of after the mobile application is given2
fertility preservation knowledge scores
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.
Time frame
Change from beginning of the study and after 3 weeks of after the mobile application is given3
fertility preservation attitude scores
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.
Time frame
Change from beginning of the study and after 3 weeks of after the mobile application is given4
Acceptance of fertility preservation
number of patients undergoing fertility preservation procedures
Time frame
Change from beginning of the study and after 3 weeks of after the mobile application is givenSponsors and contacts
Click on the lead sponsor to view all of their trials.
Biruni University
Lead sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Collaborator
Source ClinicalTrials.gov
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