After curative surgery for early-stage breast cancer, patients face a decision on whether to undergo surgery alone or to receive one or more adjuvant treatments, which may lower the risk of recurrence. Variations in survival outcomes are often marginal but there are differences in the side effects and other features of the options that patients may value differently. Hence, the patient’s values and preferences are critical in determining what option to choose. It is well-researched that the use of shared decision making and patient decision aids can support this choice in a discussion between patient and clinician. However, it is still to be investigated what impact the timing and format of the patient decision aid have on shared decision making outcomes. In this trial, we aim to investigate the impact of a digital pre-consult compared to a paper-based in-consult patient decision aid on patients’ involvement in shared decision making, decisional conflict and preparedness to make a decision. The study is a randomised controlled trial with 204 patients at two Danish oncology outpatient clinics. Eligible patients are newly diagnosed with early-stage breast cancer and offered adjuvant treatments after curative surgery to lower the risk of recurrence. Participants will be randomised to receive either an in-consult paper-based patient decision aid or a pre-consult digital patient decision aid. Data collection includes patient and clinician-reported outcomes as well as observer-reported shared decision making based on audio recordings of the consultation. The primary outcome is the extent to which patients are engaged in a shared decision making process reported by the patient. Secondary aims include the length of consultation, preparation for decision making, preferred role in shared decision making and decisional conflict. This study is the first known randomised, controlled trial comparing a digital, pre-consult patient decision aid to an identical paper-based, in-consult patient decision aid. It will contribute evidence on the impact of patient decision aids in terms of investigating if pre-consult digital patient decisions aids compared to in-consult paper-based decision aids support the cancer patients in being better prepared for decision making. ClinicalTrials.gov (NCT05573022).

中文翻译：

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乳腺癌患者决策辅助的时间和形式对其决策参与和准备的影响 - IMPACTT 随机对照试验方案

早期乳腺癌治愈性手术后，患者面临着是否单独接受手术或接受一种或多种辅助治疗的决定，这可能会降低复发风险。生存结果的差异通常很小，但副作用和患者可能不同重视的选项的其他特征存在差异。因此，患者的价值观和偏好对于确定选择何种选项至关重要。充分研究表明，使用共同决策和患者决策辅助可以在患者和临床医生之间的讨论中支持这种选择。然而，患者决策辅助的时间和形式对共同决策结果的影响仍有待研究。在这项试验中，我们的目的是调查数字预会诊与纸质会诊患者决策辅助相比，对患者参与共同决策、决策冲突和决策准备的影响。该研究是一项随机对照试验，涉及丹麦两家肿瘤门诊的 204 名患者。符合条件的患者是新诊断出患有早期乳腺癌的患者，并在根治性手术后接受辅助治疗，以降低复发风险。参与者将被随机分配接受咨询中基于纸质的患者决策辅助工具或咨询前数字患者决策辅助工具。数据收集包括患者和临床医生报告的结果以及观察者报告的基于咨询录音的共同决策。主要结果是患者参与患者报告的共同决策过程的程度。次要目标包括协商的时间长度、决策准备、在共同决策和决策冲突中的首选角色。这项研究是第一个已知的随机对照试验，将数字化的会诊前患者决策辅助工具与相同的纸质会诊中患者决策辅助工具进行比较。它将提供关于患者决策辅助的影响的证据，调查预咨询数字患者决策辅助与咨询中纸质决策辅助相比是否支持癌症患者为决策做好更好的准备。ClinicalTrials.gov (NCT05573022)。