Gynecological CancerNCT07701252
Digital Health Literacy and Oocyte Cryopreservation Among Women With Gynecological Cancer
A study testing Digital Health Literacy Education Intervention in people with Gynecological Cancer and Oocyte Cryopreservation, run by Benha University at 1 site in Egypt.
Trial summary
This study evaluated a digital health literacy education intervention related to oocyte cryopreservation among newly diagnosed women with gynecological cancer. A quasi-experimental single-group pre-post design was used at the Outpatient Clinics of the Oncology Center, Mansoura University Hospital, Egypt. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gynecological Cancer, Oocyte Cryopreservation, Digital Health Literacy
- What is being tested?
- Digital Health Literacy Education Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2025to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Oncology Center, Mansoura University Hospital
Al Mansurah, Dakahlia Governorate
About this study
Official title: Digital Health Literacy and Oocyte Cryopreservation: Perspectives of Newly Diagnosed Gynecological Cancer Women
This study evaluated a digital health literacy education intervention related to oocyte cryopreservation among newly diagnosed women with gynecological cancer. A quasi-experimental single-group pre-post design was used at the Outpatient Clinics of the Oncology Center, Mansoura University Hospital, Egypt. A purposive sample of 158 women participated. Outcomes were measured before and after the intervention and included knowledge about oocyte cryopreservation, attitudes toward oocyte cryopreservation, and decisional conflict. The intervention used videos, images, WhatsApp, Zoom, Microsoft Teams, PowerPoint slides, short text messages, simple Arabic-language educational materials, and follow-up through phone or social media when needed. Outcomes were reassessed at the end of week 4.
Read the 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.
- Conditions
- Gynecological Cancer, Oocyte Cryopreservation, Digital Health Literacy, Fertility Preservation
- Being tested
- Digital Health Literacy Education Intervention
- Keywords
- Oocyte Cryopreservation, Digital Health Literacy, Gynecological Cancer, Newly Diagnosed Women, Decisional Conflict, Knowledge, Attitude, Fertility Preservation
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Health Literacy Education InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Digital Health Literacy Intervention | Experimental | Participants received a digital health literacy education intervention related to oocyte cryopreservation. Outcomes were measured before and after the intervention. Receives: Behavioral: Digital Health Literacy Education Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Knowledge Regarding Oocyte Cryopreservation
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.
Measured: Pre-intervention and end of week 4
Change in Attitude Toward Oocyte Cryopreservation
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.
Measured: Pre-intervention and end of week 4
Change in Decisional Conflict Regarding Oocyte Cryopreservation
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.
Measured: Pre-intervention and end of week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start1 Sep 2025
- Primary completion30 Mar 2026
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gynecological CancerStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A quasi-experimental single-group pre-post study. All participants received the digital health literacy education intervention related to oocyte cryopreservation. Outcomes were measured before and after the intervention.
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Collaborators
- Mansoura University
- Responsible party
- Principal investigator, Eman Atef Elsokary, Helwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07701252
- Sponsor's protocol ID
- IRB00000844
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data supporting the study findings will be available upon reasonable request from the corresponding author.
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.
PubMed 31398258O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105.
PubMed 7898294Nelson 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.
PubMed 35486413
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Health Literacy and Oocyte Cryopreservation: Perspectives of Newly Diagnosed Gynecological Cancer Women
- ClinicalTrials.gov ID
- NCT07701252
- Acronym / sponsor ID
- IRB00000844
- Conditions
- Gynecological Cancer, Oocyte Cryopreservation, Digital Health Literacy, Fertility Preservation
- Keywords
- Oocyte Cryopreservation, Digital Health Literacy, Gynecological Cancer, Newly Diagnosed Women, Decisional Conflict, Knowledge, Attitude, Fertility Preservation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Collaborators
- Mansoura University
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluated a digital health literacy education intervention related to oocyte cryopreservation among newly diagnosed women with gynecological cancer. A quasi-experimental single-group pre-post design was used at the Outpatient Clinics of the Oncology Center, Mansoura University Hospital, Egypt. A purposive sample of 158 women participated. Outcomes were measured before and after the intervention and included knowledge about oocyte cryopreservation, attitudes toward oocyte cryopreservation, and decisional conflict. The intervention used videos, images, WhatsApp, Zoom, Microsoft Teams, PowerPoint slides, short text messages, simple Arabic-language educational materials, and follow-up through phone or social media when needed. Outcomes were reassessed at the end of week 4.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A quasi-experimental single-group pre-post study. All participants received the digital health literacy education intervention related to oocyte cryopreservation. Outcomes were measured before and after the intervention.
| Arm | Type | Receives |
|---|---|---|
| Digital Health Literacy Intervention | Experimental | Behavioral: Digital Health Literacy Education InterventionParticipants received a digital health literacy education intervention related to oocyte cryopreservation. Outcomes were measured before and after the intervention. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Health Literacy Education InterventionThe 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. | Behavioural | Digital Health Literacy Intervention |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Results publication: PubMed 31398258Ehrbar 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.
- Results publication: PubMed 7898294O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105.
- Results publication: PubMed 35486413Nelson 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.
- Individual participant dataSharing planned: Yes. Data supporting the study findings will be available upon reasonable request from the corresponding author.
Related trials for Gynecological Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Active, not recruitingPhase 2
A Three-arm Randomized Phase II Study of Dostarlimab Alone or With Bevacizumab Versus Nonplatinum Chemotherapy in Recurrent Gynecological Clear Cell Carcinoma: DOVE (APGOT-OV7/ ENGOT-ov80 Study)
Ovarian Neoplasms, Endometrial Neoplasms
RecruitingPhase 1/2
A Study of Mocertatug Rezetecan in Combination With Anti-cancer Therapies for Advanced Solid Tumors (BEHOLD-2)
Tumours, Gynecological
Active, not recruitingObservational study
Diet, Hepcidin, and Chemotherapy RDI
Breast Cancer Female, Ovarian Cancer
RecruitingObservational study
GYNGHER - HER2 Expression in Gynecological Malignancies: a Brazilian Cohort
Gynaecological Cancers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Health Literacy Education Intervention in people with Gynecological Cancer and Oocyte Cryopreservation, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Knowledge Regarding Oocyte Cryopreservation (time frame: Pre-intervention and end of week 4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07701252, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.