Empowering Women - Shared Decision Making in Managing Cervical Precancer

Not Applicable

Not yet recruiting

• Conditions: CIN2

• Registration Number: NCT07146152
• Lead Sponsor: University of Aarhus

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:

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-01
• Study First Submitted QC: 2025-08-21
• Last Update Submitted: 2025-08-21
• Study First Posted: 2025-08-28
• Last Update Posted: 2025-08-28
• Study Start: 2025-10-01
• Primary Completion: 2030-04-30
• Study Completion: 2030-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 138

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Surgical Intervention vs. Active Surveillance	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 Outcome Measures

Name	Time	Method
Decision Regret	From enrolment until 9 months follow-up.	Decision regret will be measured using the validated "Decision Regret Scale", which ranges from 1 (indicating low regret) to 5 (indicating high regret).
Anxiety levels	From enrollment until 9 months follow-up.	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.
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.	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).
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.	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).
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.	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".
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.	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).

Trial Locations

Locations (1)

Regional Hospital Gødstrup; 🇩🇰 Herning, Denmark