Shared Decision Making on Immunotherapy in Oncology - Prospective, Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 4
- 主要终点
- Knowledge about different treatment options
研究概览
简要总结
Patients with advanced melanoma are confronted with a serious treatment decision. The current guideline recommends considering the option of immunotherapy with checkpoint inhibitors. The substances approved for this purpose differ greatly in their efficacy and the risk for adverse events. Besides, in about half of the patients with advanced melanoma a BRAF V600 Mutation is found. In these patients, in addition to immunotherapy, treatment with BRAF/MEK inhibitors must be considered.
Research on shared decision making suggests that patients achieve greater satisfaction with the decision if they are actively being involved in the decision-making process. To enable them to do so, an interactive, web-based patient decision aid (PtDA) informing about the treatment options for advanced melanoma will be developed and evaluated in a bicentric, prospective randomized controlled clinical trial.
The use of PtDA is expected to lead to a higher level of information about the benefits and risks of the various treatment options (primary hypothesis).
详细描述
Immunotherapies are regarded as a new, promising treatment option for patients with advanced melanoma. However, immunotherapies can cause massive up to life-threatening side effects. The risks and benefits vary considerably between the possible therapy options. Besides, in about half of the patients with advanced melanoma a BRAF V600 Mutation is found. In these patients, in addition to immunotherapy, treatment with BRAF/MEK inhibitors must be considered. This treatment option usually produces a rapid response. In most cases, however, melanomas develop resistance after about 12 months.
Therefore, patients with advanced melanoma and their treating physicians are confronted with a very complex and preference-sensitive decision situation. Support in the form of a Patient Decision Aid (PtDA) can be helpful to support this complex decision-making process.
In the first project phase, an interactive web-based PtDA on treatment options for advanced melanomas will be developed. In the second phase of the project, the PtDA will be evaluated in a prospective randomized controlled clinical trial. Patients with a diagnosis of advanced melanoma will be recruited at the National Center for Tumor Diseases (NCT) Heidelberg and at the University Cancer Center (UCC) Dresden.
Patients of the intervention group will receive access to the interactive PtDA prior to a medical consultation. Patients of the control group will receive the medical consultation only (treatment-as-usual). Group differences between the intervention group and the control group are analysed at T1 (immediately after the medical consultation) and T2 (three months after the medical consultation). The following variables are measured: informedness of the decision (primary outcome), decision satisfaction, and involvement of the patients in the decision process.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of metastatic melanoma (C43), stage 3 and 4
- •first-line therapy
- •tumor or metastases are not resectable
- •sufficient knowledge of the German language to use the PtDA
- •informed written consent to participate in the study
排除标准
- •limited legal capacity or impairments in this respect
- •cognitive or physical impairments, which severely complicate the use of the Patient Decision Aid (e.g. impaired vision)
- •severe psychiatric or mental illness
结局指标
主要结局
Knowledge about different treatment options
时间窗: T1 = after intervention (PtDA/TAU); duration of assessment: 10 minutes
Knowledge is assessed by a self-developed multiple choice test assessing knowledge about course, benefits, risks, and mechanisms of actions of different treatment options. Higher scores indicate higher knowledge about treatment options.
次要结局
- Patient involvement in the decision making process(during medical consultation; duration of assessment: approx. 30 minutes)
- Decision satisfaction (follow-up)(T2 = approx. 3 months after intervention (PtDA/TAU), before and after being informed about potential tumor progress; duration of assessment: 2 minutes)
- Knowledge about different treatment options (follow-up)(T2: approx. 3 months after intervention (PtDA/TAU), before being informed about potential tumor progress; duration of assessment: 10 minutes)
- Decision satisfaction(T1 = after intervention (PtDA/TAU); duration of assessment: 2 minutes)
- Choice of treatment option(T1 = after the intervention (PtDA/TAU); duration of assessment: 1 minute)
- Quality of physician-patient interaction(T1 = after the intervention (PtDA/TAU); duration of assessment: 2 minutes)
研究者
Christiane Bieber
Prof. Dr. med.
Heidelberg University