Empowering Women - Shared Decision Making in Managing Cervical Precancer

NCT ID: NCT07146152

Last Updated: 2025-08-28

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2030-04-30

Brief Summary

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The aim of this stepped-wedge randomized clinical trial is to assess the impact of implementing a patient decision aid during consultations with patients diagnosed with cervical precancer. Specifically, it will evaluate whether the decision aid enhances shared decision-making, improves the patient experience, and influences their treatment preferences.

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.

Detailed Description

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Conditions

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CIN2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Stepped Wedge Randomized Controlled Trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control arm

Patients with CIN2 recieving standard information about treatment choices (Standard of Care)

Group Type NO_INTERVENTION

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.

Group Type EXPERIMENTAL

Patient Decision Aid

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Newly diagnosed CIN2
* Age 18-50 years old

Exclusion Criteria

* CIN2 or worse or conization surgery within the last 2 years.
* Pregnancy
* Immunosuppressed individuals, including those with HIV and organ transplant recipients
* Non-visible transformation zone
* Language difficulties requiring an interpreter or translator
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Region MidtJylland Denmark

OTHER

Sponsor Role collaborator

Gødstrup Hospital

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Regional Hospital Gødstrup

Herning, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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EmpowerWomen2025

Identifier Type: -

Identifier Source: org_study_id

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