Empowering Women - Shared Decision-Making in Managing Cervical Precancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of Aarhus
- Enrollment
- 138
- Locations
- 1
- Primary Endpoint
- Surgical Intervention vs. Active Surveillance
Study Overview
Brief Summary
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:
- 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?
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Control arm
Patients with CIN2 recieving standard information about treatment choices (Standard of Care)
Intervention Arm
Patients with CIN2 receiving information about treatment options using a Patient Decision Aid to promote shared decision making.
Intervention: Patient Decision Aid (Device)
Outcomes
Primary Outcomes
Surgical Intervention vs. Active Surveillance
Time Frame: The treatment decision will be documented immediately after it is made, expected within one month after inclusion.
A comparison of the number of patients choosing surgical treatment during the study period.
Secondary Outcomes
- Shared Decision Making from the doctor's point of view.(Data will be collected at a single time point, immediately following the consultation in which the treatment decision is made.)
- Shared Decision Making(Data will be collected from the time of inclusion and within a short period following the treatment decision, typically around 1 month after inclusion.)
- Decision Regret(From enrolment until 9 months follow-up.)
- Anxiety levels(From enrollment until 9 months follow-up.)
- Shared decision making(Data will be collected from the time of inclusion and within a short period following the treatment decision, typically around 1 month after inclusion.)
- Decisional conflict(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.)