Simulation-Based Patient Education to Adress Radiotherapy-Related Anxiety in Cancer Patients (ARAISE)

Cancer remains one of the leading causes of death worldwide, and the global incidence of cancer is expected to continue rising over the coming decades. A substantial proportion of patients with cancer receives radiotherapy as part of their treatment. The expected rise in cancer incidence highlights the need to continuously enhance treatment pathways and to systematically address the needs of a growing heterogeneous patient population within routine care. In this context, the psychological burdens and supportive care needs experienced by patients during treatment have gained increasing attention.

Patients receiving radiotherapy may develop physical, psychological, existential, and social needs. Psychological distress and anxiety before and during treatment may persist throughout the course of illness and can negatively affect well-being, quality of life and the overall treatment experience. In addition, different professional groups involved in cancer care may have differing perceptions of patients' needs. Interdisciplinary and patient-centred assessments of these needs, followed by appropriately tailored information and educational interventions, may therefore be particularly relevant for patients receiving radiotherapy.

The state-trait anxiety model provides an established theoretical framework for understanding anxiety in clinical settings. State anxiety refers to a temporary emotional condition characterised by feelings of tension, apprehension, and increased autonomic arousal. Its intensity may vary depending on situational stressors. In the radiotherapy setting, potential triggers of state anxiety include unfamiliar radiotherapy equipment, the treatment environment, immobilization, being alone during radiation delivery, as well as misconceptions or uncertainty about the treatment process, its potential side effects, and its anticipated effects on health and daily life. Trait anxiety, in contrast, represents a more stable personal characteristic reflecting an individual tendency to perceive objectively low-risk situations as threatening and to respond with disproportionately high levels of anxiety. Both dimensions are relevant in the radiotherapy setting and the State-Trait Anxiety Inventory is an established instrument for the standardised assessment of both parameters.

Simulation-based patient-centred education may help patients prepare for radiotherapy by making the treatment environment and procedures more familiar before the beginning of the treatment process. Through a representation of the radiotherapy setting, enabled by a specific training software, patients understanding of the equipment, treatment process, and individual treatment situation can be supported. Previous studies suggest that virtual or simulation-based education may improve patient knowledge and reduce anxiety, although findings remain heterogeneous. Combining technological simulation with personal support from health care professionals may further enhance the educational benefit.

However, important evidence gaps remain. Previous designs have often been single-centred studies with small sample sizes and substantial variation in interventions, outcome measures, and assessment time points. Therefore, the sustained effectiveness, acceptability, and feasibility of simulation-based patient education in routine radiotherapy care require further investigation. In particular, it remains important to determine whether such interventions can meaningfully reduce radiotherapy-related anxiety, improve patients' understanding of treatment, and contribute to better quality of life.

Standard care commonly includes a medical consultation and routine information before treatment. However, standard education alone may not sufficiently address individual treatment-related fears and informational needs in all patients. Furthermore, radiotherapy-specific fears have not yet been comprehensively characterised from patient and professional perspectives, and structured approaches to support understanding and empathy for these concerns are limited in the education of health care professionals.

The ARAISE study follows a three-part research programme.

First, radiotherapy-related fears, concerns, and information needs among patients with advanced cancer will be systematically assessed through a multiprofessional needs assessment, including a Delphi survey to establish consensus. The findings will be used to inform the content and structure of the educational intervention.

Second, the use of a simulation-based radiotherapy programme will be evaluated in medical students. This work package will evaluate whether the simulation programme improves healthcare professionals' self-perceived understanding of radiotherapy from before to after programme use.

Third, the clinical component of the study will evaluate the effectiveness of a simulation-based patient education intervention in patients receiving radiotherapy for cancer. In this prospective, randomised, controlled study, participants will receive either standard patient education alone or standard patient education supplemented by a structured education session before radiotherapy begins. The clinical study aims to determine whether the additional intervention can reduce radiotherapy-related state anxiety and improve health-related quality of life compared with standard patient education alone. In addition, the study will assess the feasibility and acceptability of implementing the intervention in routine radiotherapy care. Overall, ARAISE aims to develop and evaluate a patient-centred educational approach that may improve patients' preparation for radiotherapy and support the integration of their individual informational and psychological needs into routine care.

• Change in state anxiety from baseline to fifth radiotherapy fraction [Срок оценки: Baseline before randomization (T0) to fifth radiotherapy fraction (T3), approximately 1 to 3 weeks]
• Change in health-related quality of life [Срок оценки: Baseline (T0) to first radiotherapy fraction (T2) and fifth radiotherapy fraction (T3), approximately 1 to 3 weeks]
• Feasibility and acceptability of simulation-based patient education [Срок оценки: From enrollment to fifth radiotherapy fraction, approximately 3 - 4 weeks per participant]