BACKGROUND Patients with advanced cancer for whom standard systemic treatment is no longer available may be offered participation in early phase clinical trials. In the decision making process, both medical-technical information and patient values and preferences are important. Since patients report decisional conflict after deciding on participation in these trials, improving the decision making process is essential. We aim to develop and evaluate an Online Value Clarification Tool (OnVaCT) to assist patients in clarifying their values around this end-of-life decision. This improved sharing of values is hypothesized to support medical oncologists in tailoring their information to individual patients' needs and, consequently, to support patients in taking decisions in line with their values and reduce decisional conflict. METHODS In the first part, patients' values and preferences and medical oncologists' views hereupon will be explored in interviews and focus groups to build a first prototype OnVaCT using digital communication (serious gaming). Next, we will test feasibility during think aloud sessions, to deliver a ready-to-implement OnVaCT. In the second part, the OnVaCT, with accompanied training module, will be evaluated in a pre-test (12-18 months before implementation) post-test (12-18 months after implementation) study in three major Dutch cancer centres. We will include 276 patients (> 18 years) with advanced cancer for whom standard systemic therapy is no longer available, and who are referred for participation in early phase clinical trials. The first consultation will be recorded to analyse patient-physician communication regarding the discussion of patients' values and the decision making process. Three weeks afterwards, decisional conflict will be measured. DISCUSSION This project aims to support the discussion of patient values when considering participation in early phase clinical trials. By including patients before their first appointment with the medical oncologist and recording that consultation, we are able to link decisional conflict to the decision making process, e.g. the communication during consultation. The study faces challenges such as timely including patients within the short period between referral and first consultation. Furthermore, with new treatments being developed rapidly, molecular stratification may affect the patient populations included in the pre-test and post-test periods. TRIAL REGISTRATION Netherlands Trial Registry number: NTR7551 (prospective; July 17, 2018).

中文翻译：

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实现有关姑息治疗选择和早期临床试验参与的更好的医患对话：使用在线价值澄清工具（OnVaCT）。

背景技术可能不再提供标准全身治疗的晚期癌症患者可以参加早期临床试验。在决策过程中，医疗技术信息以及患者的价值观和偏好都非常重要。由于患者在决定参与这些试验后报告了决策冲突，因此改善决策过程至关重要。我们旨在开发和评估在线价值澄清工具（OnVaCT），以帮助患者根据此生命周期决定来澄清其价值。可以认为，这种价值共享的改善可以支持医学肿瘤学家根据患者的个人需求调整信息，从而支持患者根据自己的价值做出决策并减少决策冲突。方法在第一部分中，将在访谈和焦点小组中探讨患者的价值观和喜好以及医学肿瘤学家的观点，以使用数字通信（严肃游戏）构建第一个OnVaCT原型。接下来，我们将在大声思考会议期间测试其可行性，以提供现成的OnVaCT。在第二部分中，将在荷兰的三个主要癌症中心进行的前测（实施前12-18个月），后测（实施后12-18个月）研究中对带有随附培训模块的OnVaCT进行评估。我们将纳入276例（> 18岁）晚期癌症患者，这些患者不再有标准的全身治疗方法，并且被转介参加早期临床试验。第一次会诊将被记录下来，以分析有关患者价值讨论和决策过程的医患沟通。此后三周，将评估决策冲突。讨论该项目旨在支持在考虑参与早期临床试验时对患者价值的讨论。通过在首次与医学肿瘤医生会面之前将患者包括在内并记录该咨询，我们能够将决策冲突与决策过程（例如咨询期间的沟通）联系起来。该研究面临挑战，例如在转诊和初诊之间的短时间内及时纳入患者。此外，随着新疗法的迅速发展，分子分层可能会影响测试前和测试后期间的患者人群。试用注册荷兰试用注册号：NTR7551（准; 2018年7月17日）。