A Modular Cloud Platform For Fertility Preservation
A Modular CLoud Based Platform To Enhance Fertility Preservation Awareness: Design, Pilot Testing And Randomized Controlled 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).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nezihe KIZILKAYA BEJI, Professor
- Phone Number: 90+ 0532 502 34 94
- Email: nbeji@biruni.edu.tr
Study Contact Backup
- Name: Huriye Sena Kuruc, MSc
- Phone Number: 90+ 0531 458 13 13
- Email: skuruc@biruni.edu.tr
Study Locations
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Zeytinburnu
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Istanbul, Zeytinburnu, Turkey (Türkiye), 34020
- Biruni University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control- Routine information
The control group will be given an educational brochure with similar features for fertility preservation.
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Experimental: İntervention- Using the educational platform
Prof. Dr. Cemil Taşçıoğlu City Hospital will divide female patients of reproductive age (18-45 years) who have been diagnosed with gynecological cancer (early-stage cervical, ovarian, tubal, and endometrial cancer) and have not yet started treatment, and who have been referred for egg/ovarian tissue/embryo freezing, into two groups.
The intervention group will use the cloud-based sustainable education platform developed for fertility preservation within the scope of the study.
The control group will be given an educational brochure with similar features for fertility preservation.
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In this study, a modular cloud-based platform will be developed to raise awareness about fertility preservation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Awareness rates regarding fertility preservation options among patients in the experimental and control groups
Time Frame: Change from beginning of the study and after 3 weeks of after the mobile application is given
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These data will be obtained through the answers given to the "Awareness status questionnaire for fertility protection".
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Change from beginning of the study and after 3 weeks of after the mobile application is given
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Acceptance of fertility preservation
Time Frame: Change from beginning of the study and after 3 weeks of after the mobile application is given
|
number of patients undergoing fertility preservation procedures
|
Change from beginning of the study and after 3 weeks of after the mobile application is given
|
|
fertility preservation knowledge scores
Time Frame: Change from beginning of the study and after 3 weeks of after the mobile application is given
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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.
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Change from beginning of the study and after 3 weeks of after the mobile application is given
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fertility preservation attitude scores
Time Frame: Change from beginning of the study and after 3 weeks of after the mobile application is given
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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.
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Change from beginning of the study and after 3 weeks of after the mobile application is given
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nezihe KIZILKAYA BEJI, Professor, Biruni University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KAD-FR-42
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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