Clinical trial · Interventional
Empowering Women - Shared Decision Making in Managing Cervical Precancer
Empowering Women - Shared Decision-Making in Managing Cervical Precancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CIN2 | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Patient Decision Aid | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control arm
- description
- Patients with CIN2 recieving standard information about treatment choices (Standard of Care)
- type
- EXPERIMENTAL
- label
- Intervention Arm
- description
- Patients with CIN2 receiving information about treatment options using a Patient Decision Aid to promote shared decision making.
- interventionNames
- Device: Patient Decision Aid
Primary outcomes (1)
- measure
- Surgical Intervention vs. Active Surveillance
- timeFrame
- The treatment decision will be documented immediately after it is made, expected within one month after inclusion.
- description
- A comparison of the number of patients choosing surgical treatment during the study period.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available