Shared Decision Making With Breast Cancer Patients Offered Adjuvant Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 678
- 试验地点
- 7
- 主要终点
- Participant engagement in the decision making process as measured by the Shared Decision Making Questionnaire 9.
研究概览
简要总结
The aim of this project is to elucidate whether the use of shared decision making will influence patient engagement in the decision making process about adjuvant radiotherapy after breast conserving surgery for local breast cancer or early stages of local breast cancer.
详细描述
The risk of recurrence of breast cancer is lowered by adjuvant medical treatment as well as by radiotherapy (RT). On the other hand, all adjuvant treatments involve a risk of side effects; some are acute and transient while others are long-term. Considering the well-known side effects of irradiation, it seems appropriate to involve patients in the decision on whether to receive irradiation.
In the shared decision making (SDM) process clinicians and patients work together to make appropriate health decisions based on clinical evidence and the patient's informed preferences. A patient decision aid (PtDA) is instrumental in the SDM process.
This study is a multicenter, national trial randomizing doctors to either use or not use SDM and a PtDA when informing the patients about benefits and risks of receiving adjuvant radiotherapy.
It is not expected that significantly less patients will receive radiotherapy as a consequence of SDM. The primary aim of the study is to evaluate whether patient engagement in decision making is affected by SDM and the use of an in-consultation PtDA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically verified breast cancer or ductal carcinoma in situ breast cancer
- •Candidate for adjuvant radiotherapy Danish Breast Cancer Group type F after breast-conserving surgery for T1-2, N0-Nmi, M0 disease according to national guidelines.
- •Signed confirmation of participation.
排除标准
- •Bilateral breast cancer or suspicion of disseminated cancer
- •Unable to understand the information, the planned treatment or follow-up for any reason.
- •Earlier radiotherapy towards the thoracic region.
结局指标
主要结局
Participant engagement in the decision making process as measured by the Shared Decision Making Questionnaire 9.
时间窗: Within one week after the consultation
Minimum value: 0. Maximum value: 100. The higher the value the more patient engagement.
次要结局
- The doctor's perception of patient engagement in the decision making process as measured by the Shared Decision Making Questionnaire doctor 9(Within one week after the consultation)
- The participant's engagement in the decision making process as measured by the Shared Decision Making Process 4 questionnaire(Within one week after the consultation)
- The participant's regret of the treatment decision as measured by the Decision Regret Scale questionnaire(Six months after the consultation)
- The participant's engagement in the decision making process as measured by the CollaboRATE questionnaire(Within one week after the consultation)
- The participant's fear of cancer recurrence as measured by the Fear of Cancer Recurrence Short form Questionnaire(Within one week after the consultation and again after six months)
- The participant's effectiveness in decision making as measured by the Decisional Conflict Scale questionnaire(Before (12 items) and within one week after the consultation (all 16 items))
- The participant's quality of life as measured by the EORCT QLQ-C30 (version 3.0) questionnaire, only question 29 + 30(Six months)