Empowering Women - Shared Decision Making in Managing Cervical Precancer

Официальное название

Empowering Women - Shared Decision-Making in Managing Cervical Precancer

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Surgical Intervention vs. Active Surveillance [Срок оценки: The treatment decision will be documented immediately after it is made, expected within one month after inclusion.]

Вторичные конечные точки (7)

• Decision Regret [Срок оценки: From enrolment until 9 months follow-up.]
• Anxiety levels [Срок оценки: From enrollment until 9 months follow-up.]
• Shared decision making [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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. [Срок оценки: Data will be collected at a single time point, immediately following the consultation in which the treatment decision is made.]
• Decisional conflict [Срок оценки: 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.]

Критерии участия

Критерии включения

• Newly diagnosed CIN2
• Age 18-50 years old

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Дания · 1 центр

• Regional Hospital Gødstrup — Herning

Идентификаторы

NCT: NCT07146152 · EmpowerWomen2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗