Empowering Women - Shared Decision Making in Managing Cervical Precancer
NCT ID: NCT07146152
Last Updated: 2025-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
138 participants
INTERVENTIONAL
2025-10-01
2030-04-30
Brief Summary
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The main questions this study aims to answer are:
1. Will the implementation of the patient decision aid increase the number of patients with cervical precancer who opt for surgery (loop electrical excision) compared to active surveillance?
2. Will the implementation of the patient decision aid improve patients' experience with the course of treatment for cervical precancer?
To evaluate this, researchers will compare patients receiving counseling with the support of the decision aid to those receiving standard counseling without the decision aid.
After the consultation, participants will complete questionnaires to share their experience. Data on treatment choices will be gathered from patient medical records.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
SUPPORTIVE_CARE
NONE
Study Groups
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Control arm
Patients with CIN2 recieving standard information about treatment choices (Standard of Care)
No interventions assigned to this group
Intervention Arm
Patients with CIN2 receiving information about treatment options using a Patient Decision Aid to promote shared decision making.
Patient Decision Aid
A Patient Decision Aid designed to help patients with CIN2 make informed decisions about wether they prefer operation (Loop Electrical Surgery) or active surveillance.
Interventions
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Patient Decision Aid
A Patient Decision Aid designed to help patients with CIN2 make informed decisions about wether they prefer operation (Loop Electrical Surgery) or active surveillance.
Eligibility Criteria
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Inclusion Criteria
* Age 18-50 years old
Exclusion Criteria
* Pregnancy
* Immunosuppressed individuals, including those with HIV and organ transplant recipients
* Non-visible transformation zone
* Language difficulties requiring an interpreter or translator
18 Years
50 Years
FEMALE
No
Sponsors
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Region MidtJylland Denmark
OTHER
Gødstrup Hospital
OTHER
University of Aarhus
OTHER
Responsible Party
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Locations
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Regional Hospital Gødstrup
Herning, , Denmark
Countries
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Other Identifiers
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EmpowerWomen2025
Identifier Type: -
Identifier Source: org_study_id
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