- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07701252
Digital Health Literacy and Oocyte Cryopreservation Among Women With Gynecological Cancer
Digital Health Literacy and Oocyte Cryopreservation: Perspectives of Newly Diagnosed Gynecological Cancer Women
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Newly diagnosed women with gynecological cancer may face fertility-related concerns before starting cancer treatment. This study assessed whether a digital health literacy education intervention related to oocyte cryopreservation could improve women's knowledge, attitudes, and decisional conflict.
The study used a quasi-experimental single-group pre-post design. It was conducted at the Outpatient Clinics of the Oncology Center at Mansoura University Hospital, Dakahlia Governorate, Egypt. The study included 158 newly diagnosed women with gynecological cancer selected using purposive sampling.
Eligible participants were women aged 18 to 45 years who were newly diagnosed with gynecological cancer, had not received cancer treatment, had not received cryopreservation instructions before, and had access to a smartphone, internet connection, and social media. Women who had received chemotherapy, radiotherapy, or hormonal therapy, or who had learning difficulties such as dementia or vision impairment, were excluded.
were women Baseline data were collected using a structured interview questionnaire and study tools assessing knowledge about gynecological cancer and oocyte cryopreservation, attitudes toward oocyte cryopreservation, and decisional conflict. The digital health literacy intervention was delivered using videos, visually engaging images, WhatsApp groups, Zoom and Microsoft Teams meetings, PowerPoint slides, short text messages, interactive visuals and animations, simple Arabic language, and instructive pictures. The educational content covered general information about gynecological cancer and fertility, fertility preservation options, and detailed information about oocyte cryopreservation, including definition, indications, advantages, benefits, and process steps. Content also included embryo cryopreservation, ovarian tissue cryopreservation, fertility-sparing surgery, and ovarian transposition.
Four sessions were delivered, with 20 women per group. Each session was held three days per week on Sunday, Tuesday, and Thursday and lasted 30 to 45 minutes. Follow-up was conducted by phone or social media as needed to reinforce planning and address barriers. Outcomes were reassessed at the end of week 4 using the same instruments.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Dakahlia Governorate
-
Al Mansurah, Dakahlia Governorate, Egypt
- Oncology Center, Mansoura University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Newly diagnosed women with gynecological cancers who had not received any treatment.
- Women of reproductive age, 18-45 years.
- Women with gynecological cancers who had not received cryopreservation instructions before.
- Women who had a smartphone, internet connection, could use social media, and had access to the internet through their phone.
Exclusion Criteria:
- Women with gynecological cancer who had received cancer treatment, including chemotherapy, radiotherapy, or hormonal therapy.
- Women diagnosed with learning difficulties, such as dementia or vision impairment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Digital Health Literacy Intervention
Participants received a digital health literacy education intervention related to oocyte cryopreservation.
Outcomes were measured before and after the intervention.
|
The intervention included videos, visually engaging images, WhatsApp groups, Zoom and Microsoft Teams meetings, PowerPoint slides, short text messages, interactive visuals/animations, simple Arabic-language educational materials, and instructive pictures.
The educational content covered general information about gynecological cancer and fertility, fertility-preservation options, and detailed information about oocyte cryopreservation, including definition, indications, advantages/benefits, and process/steps.
Content also included embryo cryopreservation, ovarian tissue cryopreservation, fertility-sparing surgery, and ovarian transposition.
Follow-up was conducted by phone or social media as needed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Knowledge Regarding Oocyte Cryopreservation
Time Frame: Pre-intervention and end of week 4
|
Knowledge regarding oocyte cryopreservation was assessed using the Oocyte Cryopreservation Knowledge Questionnaire.
The questionnaire included 20 multiple-choice questions covering general information about gynecological cancer and fertility, fertility preservation options, and oocyte cryopreservation.
Each correct answer was scored 1 and each incorrect or "don't know" answer was scored 0. The total score ranged from 0 to 20, with higher scores indicating higher knowledge.
Scores of 60% or higher were classified as satisfactory knowledge.
|
Pre-intervention and end of week 4
|
|
Change in Attitude Toward Oocyte Cryopreservation
Time Frame: Pre-intervention and end of week 4
|
Attitude toward oocyte cryopreservation was assessed using an attitude scale developed by the researchers after reviewing the literature.
The scale included 15 statements: 11 positive statements and 4 negative statements.
Responses were scored using a three-point Likert scale: agree = 2, uncertain = 1, and disagree = 0. Negatively worded items were reverse scored.
The total score ranged from 0 to 30, with higher scores indicating a more positive attitude toward oocyte cryopreservation.
Scores of 70% or higher were classified as positive attitude.
|
Pre-intervention and end of week 4
|
|
Change in Decisional Conflict Regarding Oocyte Cryopreservation
Time Frame: Pre-intervention and end of week 4
|
Decisional conflict regarding oocyte cryopreservation was assessed using the 16-item Decisional Conflict Scale.
Items were organized into five domains related to feeling informed, value clarification, support, uncertainty, and effective decision-making.
Responses were scored on a five-point scale from strongly agree to strongly disagree.
The total score ranged from 0 to 100, with higher scores indicating greater decisional conflict.
Scores less than 25 indicated low decisional conflict, scores between 25 and 37.5 indicated moderate decisional conflict, and scores above 37.5 indicated high decisional conflict.
|
Pre-intervention and end of week 4
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Ehrbar V, Urech C, Rochlitz C, Zanetti Dallenbach R, Moffat R, Stiller R, Germeyer A, Nawroth F, Dangel A, Findeklee S, Tschudin S. Randomized controlled trial on the effect of an online decision aid for young female cancer patients regarding fertility preservation. Hum Reprod. 2019 Sep 29;34(9):1726-1734. doi: 10.1093/humrep/dez136.
- O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105.
- Nelson LA, Pennings JS, Sommer EC, Popescu F, Barkin SL. A 3-Item Measure of Digital Health Care Literacy: Development and Validation Study. JMIR Form Res. 2022 Apr 29;6(4):e36043. doi: 10.2196/36043.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00000844
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Gynecological Cancer
-
National Taipei University of Nursing and Health...Not yet recruiting
-
Lena NilssonCompleted
-
University of ChesterCompleted
-
Affiliated Hospital of Nantong UniversityRecruitingGynecological CancerChina
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.UnknownGynecological CancerChina
-
Fondazione Policlinico Universitario Agostino Gemelli...Not yet recruitingImmunotherapy | Gynecological Cancer
-
Universiti Putra MalaysiaRecruitingGynecological Cancer | Elective SurgeryMalaysia
-
Bakirkoy Dr. Sadi Konuk Research and Training HospitalCompletedThe Effect of Analgesia Methods Applied in Gynecological Cancer Surgeries on Postoperative AnalgesiaRegional Anesthesia Morbidity | Gynecological Cancer SurgeryTurkey
-
Rajavithi HospitalCompletedPostoperative Outcomes | Whey Protein | Gynecological Cancer SurgeryThailand
-
Sichuan Cancer Hospital and Research InstituteRecruitingGynecological CancerChina
Clinical Trials on Digital Health Literacy Education Intervention
-
Forman Christian College, PakistanSaglik Bilimleri Universitesi; doctHERsCompleted
-
The University of Hong KongSino Group; NG TENG FONG Charitable FoundationCompleted
-
Rana Mohamed Ahmed FarghalCairo University; Military Medical Academy, BulgariaNot yet recruitingDental Caries | Knowledge, Attitudes, Practice | Preventive Health Care | Child Behavioral Health | Oral Health Behavior Change | Oral Hygiene, Oral HealthEgypt
-
The Hong Kong Polytechnic UniversityNot yet recruiting
-
Huzhou Normal UniversityUnknownHypertension | Health Literacy
-
Giresun UniversityRecruitingDigital Literacy | Digital Privacy | Online Privacy AwarenessTurkey (Türkiye)
-
National University of SingaporeNot yet recruitingAged | Cognition | Digital Health LiteracySingapore
-
Johns Hopkins UniversityNational Institute on Aging (NIA)Active, not recruitingQuality of Life | Aging | Technology | LiteracyUnited States
-
Adai Technology (Beijing) Co., Ltd.Recruiting
-
Istanbul University - Cerrahpasa (IUC)RecruitingQuality of Life | Postmenopausal Symptoms | Health Literacy | Literacy | DigitalismTurkey