Implementing a Decision Aid for Breast Cancer and DCIS Patients Deciding on Their Radiation Treatment: A Pre- and Post-intervention Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 403
- 试验地点
- 8
- 主要终点
- Decisional conflict
研究概览
简要总结
This is a pre-and post intervention study on the effect and implementation of an personalized decision aid for woman with breast cancer who face a decision on their radiation treatment.
详细描述
Rationale: Guidelines on breast cancer treatment show grey areas for some radiotherapy (RT) indications. In some recommendations the uncertainty is marked and deferred to sharing the final decision on the treatment of choice with the patient. Other recommendations are straightforward, but the multidisciplinary team may decide, based on the latest literature, that different options should be discussed with the patient. In these so called "preference sensitive decisions" there is not one best option. The best option depends on the individual patients' preferences based on neutral and complete information tailored to her own situation. Decision aids support clinicians as well as patients in Shared Decision Making (SDM). Decision aids reduce the patient's decisional conflict after making their decision, increase their knowledge on their illness and the treatment options, and their perceived level of involvement in the decision making process. Although extensive research has been carried out on the effect of decision aids in clinical trials, less is known of the effect of a decision aid in daily clinical practice. The implementation of SDM is challenged by many barriers. The investigators hypothesize that adapting the decision aid to individual patient characteristics may enhance both personalised medicine and SDM.
Objective: To investigate whether SDM using a personalised decision aid, results in improved outcomes of decisional quality, measured by the Decisional Conflict Scale after 3 months and one year, and improved outcomes of the decisional process, measured with the SDMQ9 and collaboRATE directly after the last consultation, compared to the standard clinical practices in breast cancer patients facing a decision on their radiation treatment.
Study design: This is a multicenter clustered , pre- and post-intervention study. Before the intervention 164 patients will be included. After introducing the decision aid, at the beginning of the intervention period, clinicians will be trained in using the decision aid and the other 164 patients will be recruited.
Study population: Breast cancer patients facing a decision in their adjuvant radiation treatment.
Intervention: The intervention group will receive the instructions and the online decision aid.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
盲法说明
first 164 patients will not receive the decision aid, they will only fill out the questionnaires.
The next 164 patients will receive the decision aid and will be asked to fill out the same questionnaires.
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
- •18 years or older
- •Doubtful indication of:
- •Whole breast irradiation after lumpectomy for DCIS
- •Whole breast irradiation after lumpectomy for low risk invasive BC (TOP-1 study)
- •Boost dose in case of Breast Conserving Therapy
- •Thoracic wall irradiation post mastectomy
排除标准
- •Metastasis
- •Inability to speak and read Dutch. Inability to use internet access, either in the home or at a hospital facility.
结局指标
主要结局
Decisional conflict
时间窗: 90 days after the decision on their radiation treatment has been made
measured with on the decisional conflict scale. Measured by the decisional conflict scale ( O'Connor, 1995), This contains 16 questions answered on a 5 point likert scale( strongly agree-strongly disagree). Items are given a score value of 0-4. The total score is calculated by: summed, divided by 16 and multiplied by 25. scores range from 0 ( no decisional conflict to 100 (extreme high decisional conflict). The scale also consist of 5 subscales: uncertainty subscore, informed subscore, values subscore, support subscore and the effective decision subscore.
次要结局
- Decisional conflict(365 days after the decision on adjuvant RT has been made)
- Patient knowledge(directly after the decision on adjuvant RT has been made (<3 days))
- Prospective process evaluation(directly after the decision on adjuvant RT has been made (<3 days))
- Improvement on the perceived level of shared decision making.(90 days after the decision on their radiation treatment has been made)