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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
Patient Decision Aid
DeviceA Patient Decision Aid designed to help patients with CIN2 make informed decisions about wether they prefer operation (Loop Electrical Surgery) or active surveillance.
Treatment groups
138 Participants
are divided into 2 treatment groupsGroup A: Control armNo intervention 0 interventions
Group B: Intervention ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Surgical Intervention vs. Active Surveillance
A comparison of the number of patients choosing surgical treatment during the study period.
Time frame
The treatment decision will be documented immediately after it is made, expected within one month after inclusion.Secondary outcomes
1
Decision Regret
Decision regret will be measured using the validated "Decision Regret Scale", which ranges from 1 (indicating low regret) to 5 (indicating high regret).
Time frame
From enrolment until 9 months follow-up.2
Anxiety levels
Participants' anxiety levels will be measured both before and after they make a decision regarding their treatment. The validated "State-Trait Anxiety Inventory" (STAI) will be used, which rates anxiety on a scale from 1 to 4, with 4 indicating the highest level of anxiety.
Time frame
From enrollment until 9 months follow-up.3
Shared decision making
Measurement of degree of shared decision-making from the participants' point of view using validated questionnaire "CollaboRATE". Patients report to which degree they felt the doctor fascilitated shared decision-making during the consultation. The scale ranges from 1 (to the lowest degree) to 9 (to the highest degree).
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.4
Shared Decision Making
The degree of shared decision-making will be assessed from the participants' point of view using the validated questionnaire "Shared Decision-Making Process-4".
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: