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

Despite continued medical progress, cancer remains one of the leading causes of death worldwide. A significant number of cancer patients receive radiation therapy at some point during the treatment process, depending on the expected therapeutic benefit. The continued rise in the incidence of malignant diseases highlights the need to refine existing treatment pathways and integrate them into a comprehensive continuum of patient-centered care. A key component of these efforts is the systematic collection and assessment of the needs of patients in a growing and increasingly diverse patient population. In the field of radiation therapy, anxiety and psychological distress are clinically relevant factors that may have a lasting negative impact both on the subjective treatment experience and on treatment compliance, treatment preparation, and treatment quality. A large percentage of radiation therapy patients experience a level of psychological distress that is considered clinically significant and requires treatment. The resulting needs can be categorized into physical, psychological, and social dimensions, and the extent of the observed psychological distress varies significantly among different tumor types but essentially remains stable over the treatment course, with a slight tendency to decrease. Assessments of patient needs often differ among the professional groups participating in the therapy process. The currently standard practice of information counseling conducted by a physician alone is often insufficient to effectively address or alleviate existing treatment-related anxieties. The state-trait anxiety model developed by Charles Spielberger distinguishes between two different forms of anxiety. State anxiety describes a temporary emotional state associated with increased stimulation of the autonomic nervous system, and its intensity can fluctuate. In the context of radiation therapy, potential triggers may include the treatment machine with its specific sounds, the windowless treatment room with its heavy lead-lined door, and the inevitable situation in which the patient is alone during the treatment session. Trait anxiety, on the other hand, is a dispositional factor that represents a stable personality trait and describes the tendency to mistakenly assess objectively low-risk situations as threatening and to react with a disproportionately high level of anxiety. Both dimensions are relevant to the study context, as patients with pronounced trait anxiety generally react more strongly to stress-inducing situations, which in turn can manifest as increased state anxiety. The State-Trait Anxiety Inventory (STAI) is the established tool for the standardized assessment of both dimensions. A validated German-language adaptation (STAI-G) is available. To address these fears, immersive simulation techniques that provide patient-oriented guidance and, as a result, offer more personalized, one-on-one counseling can be valuable in alleviating the anxiety. The ARAISE project addresses these gaps in two consecutive parts. The first study part is a Delphi consensus procedure comprising two to three rounds involving radiation therapists, psycho-oncologists, patient representatives, physicians, and users of the VERT simulation software. In this process, treatment-specific fears of patients undergoing radiation therapy are identified from a multiprofessional perspective and ranked by priority. Its results determine the content of the educational intervention evaluated in the second study part. The subsequent second study part is a prospective, single-center, randomized controlled study with a 1-to-1 allocation ratio and a planned sample size of 144 patients. The participants in the control group receive standard counseling, provided prior to the start of radiation therapy. Participants in the intervention group will receive the same standard counseling, supplemented by a one-time, structured, simulation-based counseling session lasting 15 to 20 minutes, which will be conducted after the planning CT scan and before the first radiation therapy fraction. The session uses the immersive radiation therapy simulation software VERT 9.0 and is led by the principal investigator conducting the study, a medical educator with many years of clinical experience in radiation therapy. Assessments are performed at four time points: T0 (baseline before randomization), T1 (immediately after the planning CT or after the education session), T2 (first radiotherapy fraction), and T3 (fifth radiotherapy fraction). The primary endpoint is state anxiety at T2, measured with the STAI-G Form X1 and adjusted for the baseline value at T0. Secondary endpoints are state anxiety at T1 and T3, HRQoL at T3 (EORTC QLQ-C30), and the perceived amount of information received at T1 (EORTC QLQ-INFO25). Overall, ARAISE aims to develop and evaluate a patient-centered educational approach that may improve patients' preparation for radiotherapy and support the integration of their individual informational and psychological needs into routine care.

Inclusion criteria

• Age 18 years or older
• Histologically or cytologically confirmed malignant tumor disease
• Stage I - III (UICC TNM classification)
• ECOG performance status ≤ 2
• Curative-intent external beam radiotherapy regimen with at least 5 fractions
• First course of radiotherapy
• Able to independently operate the electronic data collection instrument
• Written informed consent after study information
• Sufficient German language proficiency to read and complete the study questionnaires independently and without translation assistance

Exclusion criteria

• Lack of capacity to provide informed consent
• Pregnancy or breastfeeding
• Stereotactic radiotherapy
• Emergency treatment indication
• Acute suicidality, acute psychosis, or other acute psychiatric disorder
• Initiation of or dose change in psychotropic medication within 4 weeks before baseline (T0)
• Cognitive impairment that precludes independent completion of the questionnaires
• Visual or auditory impairment that prevents perception of the on-screen or audio content despite available aids