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).
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Nezihe KIZILKAYA BEJI, Professor
- Telefonnummer: 90+ 0532 502 34 94
- E-Mail: nbeji@biruni.edu.tr
Studieren Sie die Kontaktsicherung
- Name: Huriye Sena Kuruc, MSc
- Telefonnummer: 90+ 0531 458 13 13
- E-Mail: skuruc@biruni.edu.tr
Studienorte
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Zeytinburnu
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Istanbul, Zeytinburnu, Türkei (türkiye), 34020
- Biruni University
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Kein Eingriff: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Awareness rates regarding fertility preservation options among patients in the experimental and control groups
Zeitfenster: 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
Zeitfenster: Change from beginning of the study and after 3 weeks of after the mobile application is given
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number of patients undergoing fertility preservation procedures
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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 knowledge scores
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Nezihe KIZILKAYA BEJI, Professor, Biruni University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- KAD-FR-42
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
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