Empowering Women - Shared Decision Making in Managing Cervical Precancer

University of Aarhus

Status: Not yet enrolling

Conditions: CIN2

Treatments: Device: Patient Decision Aid

Study type: Interventional

Funder types: Other

Identifiers

NCT07146152

EmpowerWomen2025

Details and patient eligibility

About

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.

Enrollment: 138 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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138 participants in 2 patient groups

Control arm

No Intervention group

Description:

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

Intervention Arm

Experimental group

Description:

Patients with CIN2 receiving information about treatment options using a Patient Decision Aid to promote shared decision making.

Treatment:

Device: Patient Decision Aid