NCT07701252

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 14, 2026

Completed
Last Updated

July 14, 2026

Status Verified

July 1, 2026

Enrollment Period

7 months

First QC Date

July 8, 2026

Last Update Submit

July 8, 2026

Conditions

Keywords

Oocyte CryopreservationDigital Health LiteracyGynecological CancerNewly Diagnosed WomenDecisional ConflictKnowledgeAttitudeFertility Preservation

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Pre-intervention and end of week 4

Study Arms (1)

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.

Behavioral: Digital Health Literacy Education Intervention

Interventions

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.

Digital Health Literacy Intervention

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oncology Center, Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, Egypt

Location

Related Publications (3)

  • 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.

MeSH Terms

Conditions

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of obstetrics and gynecology

Study Record Dates

First Submitted

July 8, 2026

First Posted

July 14, 2026

Study Start

September 1, 2025

Primary Completion

March 30, 2026

Study Completion

March 30, 2026

Last Updated

July 14, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

Data supporting the study findings will be available upon reasonable request from the corresponding author.

Shared Documents
STUDY PROTOCOL
Time Frame
Available upon reasonable request after publication.
Access Criteria
Researchers may request access to the data from the corresponding author.

Locations