Empowering Women - Shared Decision-Making in Managing Cervical Precancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Surgical Intervention vs. Active Surveillance
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed CIN2
- •Age 18-50 years old
排除标准
- •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
研究组 & 干预措施
Control arm
Patients with CIN2 recieving standard information about treatment choices (Standard of Care)
Intervention Arm
Patients with CIN2 receiving information about treatment options using a Patient Decision Aid to promote shared decision making.
干预措施: Patient Decision Aid (Device)
结局指标
主要结局
Surgical Intervention vs. Active Surveillance
时间窗: 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.
次要结局
- 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.)
- 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.)
- Decision Regret(From enrolment until 9 months follow-up.)
- Anxiety levels(From enrollment until 9 months follow-up.)
- 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.)
- 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.)