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NCT Number: NCT07146152

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:

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.

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Key information

Conditions

CIN2 Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Neoplasms Precancerous Conditions Urogenital Diseases Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Regional Hospital Gødstrup

Herning, 7400, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient Decision Aid

Device

A Patient Decision Aid designed to help patients with CIN2 make informed decisions about wether they prefer operation (Loop Electrical Surgery) or active surveillance.

Primary outcomes

  1. 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

  1. Decision Regret

    Time frame: 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).

  2. Anxiety levels

    Time frame: 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.

  3. 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.

    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).

  4. 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.

    The degree of shared decision-making will be assessed from the participants' point of view using the validated questionnaire "Shared Decision-Making Process-4".

  5. 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.

    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).

  6. 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.

    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".

  7. 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.

    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).

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Gødstrup Hospital
  • Region MidtJylland Denmark

Registry information

Official study title

Empowering Women - Shared Decision-Making in Managing Cervical Precancer

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Aug 28, 2025
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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