Fertility Preservation, Gynecologic Cancers
Conditions
Keywords
fertility, gynecologic cancer, fertility preservation, mobile application
Brief summary
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).
Detailed description
This is a randomized controlled experimental study. The research was carried out in the Prof. Dr. Cemil Tascioglu City Hospital.
Interventions
OTHERDeveloping a Modular Cloud-Based Platform to guide decision-making in fertility preservation
In this study, a modular cloud-based platform will be developed to raise awareness about fertility preservation.
Sponsors
Biruni University
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
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). In study, In the intervention group (n = 70), the mobile application will be downloaded and demonstrated to the participants. In the control group (n = 70) will receive only a printed brochure containing the same content as the mobile application.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Awareness rates regarding fertility preservation options among patients in the experimental and control groups | 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". |
| fertility preservation knowledge scores | 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 | 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. |
| Acceptance of fertility preservation | Change from beginning of the study and after 3 weeks of after the mobile application is given | number of patients undergoing fertility preservation procedures |
Countries
Turkey (Türkiye)
Contacts
CONTACTNezihe KIZILKAYA BEJI, Professor
CONTACTHuriye Sena Kuruc, MSc
PRINCIPAL_INVESTIGATORNezihe KIZILKAYA BEJI, Professor
Biruni University
Outcome results
None listed