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Not yet recruiting NCT07146152

Empowering Women - Shared Decision Making in Managing Cervical Precancer

No phase Interventional CIN2

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Patient Decision Aid.
Who it may be relevant to
Registry conditions: CIN2. Basic parameters: 18 years — 50 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Empowering Women - Shared Decision-Making in Managing Cervical Precancer

Overview

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.

Interventions

  • Device 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.

Primary outcome measures

  • Surgical Intervention vs. Active Surveillance [Time frame: The treatment decision will be documented immediately after it is made, expected within one month after inclusion.]
Secondary outcome measures (7)
  • Decision Regret [Time frame: From enrolment until 9 months follow-up.]
  • Anxiety levels [Time frame: From enrollment until 9 months follow-up.]
  • Shared decision making [Time frame: Data will be collected from the time of inclusion and within a short period following the treatment decision, typically around 1 month after inclusion.]
  • Shared Decision Making [Time frame: Data will be collected from the time of inclusion and within a short period following the treatment decision, typically around 1 month after inclusion.]
  • Shared Decision Making [Time frame: Data will be collected from the time of inclusion and within a short period following the treatment decision, typically around 1 month after inclusion.]
  • Shared Decision Making from the doctor's point of view. [Time frame: Data will be collected at a single time point, immediately following the consultation in which the treatment decision is made.]
  • Decisional conflict [Time frame: The questionnaire is administered at two time points: prior to the consultation regarding treatment choice, and immediately after the consultation. Data collection is expected to be completed within one month of enrollment.]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Open label
Primary purpose
Supportive care

Study locations

Denmark · 1 center
  • Regional Hospital Gødstrup — Herning

Identifiers

NCT: NCT07146152 · EmpowerWomen2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗