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).
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Nezihe KIZILKAYA BEJI, Professor
- Numero di telefono: 90+ 0532 502 34 94
- Email: nbeji@biruni.edu.tr
Backup dei contatti dello studio
- Nome: Huriye Sena Kuruc, MSc
- Numero di telefono: 90+ 0531 458 13 13
- Email: skuruc@biruni.edu.tr
Luoghi di studio
-
-
Zeytinburnu
-
Istanbul, Zeytinburnu, Turchia (Türkiye), 34020
- Biruni University
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Nessun intervento: Control- Routine information
The control group will be given an educational brochure with similar features for fertility preservation.
|
|
|
Sperimentale: 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.
|
In this study, a modular cloud-based platform will be developed to raise awareness about fertility preservation.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Awareness rates regarding fertility preservation options among patients in the experimental and control groups
Lasso di tempo: Change from beginning of the study and after 3 weeks of after the mobile application is given
|
These data will be obtained through the answers given to the "Awareness status questionnaire for fertility protection".
|
Change from beginning of the study and after 3 weeks of after the mobile application is given
|
|
Acceptance of fertility preservation
Lasso di tempo: 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
Lasso di tempo: 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.
|
Change from beginning of the study and after 3 weeks of after the mobile application is given
|
|
fertility preservation attitude scores
Lasso di tempo: 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.
|
Change from beginning of the study and after 3 weeks of after the mobile application is given
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Nezihe KIZILKAYA BEJI, Professor, Biruni University
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- KAD-FR-42
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .