CIN2NCT07146152
Empowering Women - Shared Decision Making in Managing Cervical Precancer
A study testing Patient Decision Aid in people with CIN2, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- CIN2
- What is being tested?
- Patient Decision Aid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2025to 30 Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Newly diagnosed CIN2
- Age 18-50 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Empowering Women - Shared Decision-Making in Managing Cervical Precancer
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:
Read more
- 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.
- Conditions
- CIN2
- Being tested
- Patient Decision Aid
- Keywords
- Shared decision making, Cervical precancer, Cervical intraepithelial neoplasia, Shared Decision-making, SDM, Patient Decision Aid, CIN2
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Decision AidDevice
A Patient Decision Aid designed to help patients with CIN2 make informed decisions about wether they prefer operation (Loop Electrical Surgery) or active surveillance.
| Study group | Role | What they receive |
|---|---|---|
| Control arm | No intervention | Patients with CIN2 recieving standard information about treatment choices (Standard of Care) |
| Intervention Arm | Experimental | Patients with CIN2 receiving information about treatment options using a Patient Decision Aid to promote shared decision making. Receives: Device: Patient Decision Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Intervention vs. Active Surveillance
A comparison of the number of patients choosing surgical treatment during the study period.
Measured: The treatment decision will be documented immediately after it is made, expected within one month after inclusion.
Secondary outcomes (7)
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).
Measured: From enrolment until 9 months follow-up.
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.
Measured: From enrollment until 9 months follow-up.
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).
Measured: 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
The degree of shared decision-making will be assessed from the participants' point of view using the validated questionnaire "Shared Decision-Making Process-4".
Measured: 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
The extent of shared decision-making will be assessed from the participants' point of view using the validated questionnaire "Shared Decision Making Questionnaire Q9 (SDM-Q-9).
Measured: 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.
The degree of shared decision-making will be assessed from the physician's point of view using the validated questionnaire "Shared Decision Making Questionnaire - Physician Version".
Measured: Data will be collected at a single time point, immediately following the consultation in which the treatment decision is made.
Decisional conflict
Measurement of decisional conflict using the validated questionnaire "Decisional Conflict Scale". The scale ranges from 1 (low degree of decisional conflict) to 5 (high degree of decisional conflict).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start1 Oct 2025 (estimated)
- Primary completion30 Apr 2030 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CIN2Studies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Stepped Wedge Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Region MidtJylland Denmark, Gødstrup Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07146152
- Sponsor's protocol ID
- EmpowerWomen2025
- Status last verified
- Jul 2025
- First submitted
- 1 Jul 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowering Women - Shared Decision-Making in Managing Cervical Precancer
- ClinicalTrials.gov ID
- NCT07146152
- Acronym / sponsor ID
- EmpowerWomen2025
- Conditions
- CIN2
- Keywords
- Shared decision making, Cervical precancer, Cervical intraepithelial neoplasia, Shared Decision-making, SDM, Patient Decision Aid, CIN2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Region MidtJylland Denmark, Gødstrup Hospital
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 30 Apr 2030 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped Wedge Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Control arm | No intervention | –Patients with CIN2 recieving standard information about treatment choices (Standard of Care) |
| Intervention Arm | Experimental | Device: Patient Decision AidPatients with CIN2 receiving information about treatment options using a Patient Decision Aid to promote shared decision making. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Newly diagnosed CIN2
- Age 18-50 years old
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Decision AidA Patient Decision Aid designed to help patients with CIN2 make informed decisions about wether they prefer operation (Loop Electrical Surgery) or active surveillance. | Device | Intervention Arm |
Primary outcome
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.
7 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Decision Aid in people with CIN2, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Intervention vs. Active Surveillance (time frame: The treatment decision will be documented immediately after it is made, expected within one month after inclusion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.