Empowering Women - Shared Decision Making in Managing Cervical Precancer

ConditionCIN2
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorUniversity of Aarhus

About this trial

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.

Eligibility criteria

Qualifiers

Newly diagnosed CIN2

Age 18-50 years old

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Patient Decision Aid

Treatment groups

138 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Aarhus

Lead sponsor

Region MidtJylland Denmark

Collaborator

Gødstrup Hospital

Collaborator