BACKGROUND Information on the prevalence of adjustment disorders among cancer patients and the value of psychological interventions in this group of patients is limited. This study investigates the prevalence of adjustment disorders among cancer patients as well as the reach, effectiveness, cost-utility and budget impact of a tailored psychological intervention. METHOD This study consists of two parts. Part 1 is an observational study among a representative group of mixed cancer patients after cancer treatment on the prevalence of adjustment disorder as well as the uptake (i.e. reach) of psychological treatment. In Part 2, patients diagnosed with an adjustment disorder are invited to participate in a randomized controlled trial. Patients will be randomized to the intervention (access to the tailored psychological intervention) or control group (waitlist period of 6 months). The psychological intervention consists of three modules: one module containing psycho-education (3 sessions, all patients) and two additional modules (maximum of 6 sessions per module) provided as continuum, in case needed. Module 2 and 3 can consist of several evidence-based interventions (e.g. group interventions, mindfulness, eHealth) The primary outcome is psychological distress (HADS). Secondary outcomes are mental adjustment to cancer (MAC) and health-related quality of life (EORTC QLQ-C30). To assess the cost-utility and budget impact, quality of life (EQ-5D-5 L) and costs (iMCQ and iPCQ) will be measured. Measures will be completed at baseline and 3 and 6-months after randomization. DISCUSSION This study will provide data of the prevalence of adjustment disorders and the reach, effectiveness, cost-utility and budget impact of a tailored psychological intervention. TRIAL REGISTRATION Netherlands Trial Register identifier: NL7763. Registered on 3 June 2019.

中文翻译：

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癌症患者中适应障碍的患病率，以及量身定制的心理治疗的覆盖面，有效性，成本效用和预算影响：一项随机对照试验的研究方案。

背景技术关于癌症患者中适应障碍的患病率以及该组患者中心理干预的价值的信息是有限的。这项研究调查了癌症患者中适应障碍的患病率，以及量身定制的心理干预措施的覆盖范围，有效性，成本效用和预算影响。方法本研究包括两个部分。第一部分是在癌症治疗后的一组代表性混合癌症患者中进行的观察性研究，以了解适应症的患病率以及心理治疗的吸收（即达到）水平。在第2部分中，邀请被诊断患有调节障碍的患者参加随机对照试验。患者将被随机分为干预组（接受量身定制的心理干预）或对照组（等待期为6个月）。心理干预包括三个模块：一个模块包含心理教育（3个疗程，所有患者），另外两个模块（每个模块最多6个疗程）作为连续体提供（如果需要）。模块2和模块3可以包含几种基于证据的干预措施（例如，小组干预，正念，电子卫生保健）。主要结果是心理困扰（HADS）。次要结果是对癌症（MAC）的心理适应以及与健康相关的生活质量（EORTC QLQ-C30）。为了评估成本效用和预算影响，将对生活质量（EQ-5D-5 L）和成本（iMCQ和iPCQ）进行衡量。措施将在基线以及随机分组后3个月和6个月内完成。讨论本研究将提供适应症患病率的数据以及量身定制的心理干预措施的覆盖范围，有效性，成本效用和预算影响。试用注册荷兰试用注册的标识符：NL7763。于2019年6月3日注册。