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

Addressing Radiotherapy Anxiety Through Immersive Simulation and Education: Effects of a Simulation-Based Patient Education Intervention on Psychosocial Burden in Cancer Patients Receiving Radiotherapy (ARAISE)

For the majority of cancer patients, radiotherapy is a crucial component of their treatment process. However, many patients experience anxiety before or during radiotherapy. This anxiety may be related not only to the cancer diagnosis and its prognosis but also to unfamiliar aspects of the treatment process, the equipment, and the treatment environment. General or non-specific feelings of anxiety may also become associated with the radiotherapy setting, even when patients are not able to identify a specific treatment-related concern. Uncertainty about what will happen during treatment sessions can further increase anxiety and may affect patients' overall well-being. The ARAISE project consists of two consecutive parts. In the first part, health care professionals from different disciplines and patient representatives take part in a Delphi consensus process to identify and prioritize the treatment-specific fears of patients receiving radiotherapy. The results of this first part are used to define the content of the education session that is tested in the second part. The second part is a randomized controlled study in patients receiving radiotherapy for cancer. Participants will be assigned by chance, in equal numbers, to one of two groups. All participants will receive the usual patient education provided before radiotherapy. In addition, participants in one group will receive a single immersive, simulation-based education session after the planning CT scan and before the start of treatment. The main question is whether the additional session leads to lower state anxiety at the first radiotherapy fraction compared with usual patient education alone. The study also compares state anxiety at other time points, health-related quality of life, and how well informed participants feel about their treatment. Finally, the study assesses whether the additional education session is feasible, well accepted, and practical to provide as part of routine radiotherapy care.

Study Overview

• Status: Not yet recruiting
• Conditions: Neoplasms; Anxiety
• Intervention / Treatment: Other: Simulation-Based Patient Education

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 144
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rami El Shafie, Prof. Dr. med; Phone Number: +49 551 3964501; Email: rami.elshafie@med.uni-goettingen.de
• Study Contact Backup: Name: Stephan-Peter Landgraff, M.Ed.; Phone Number: +49 30 76 68 37 5 600; Email: stephan.landgraff@medicalschool-berlin.de

Study Locations

• Germany
  • Lower Saxony
    • Göttingen, Lower Saxony, Germany, 37075
      • Department of Radiotherapy and Radiation Oncology, University Medical Center Goettingen
      • Contact: Stephan-Peter Landgraff, M.Ed.; Phone Number: +49 5513964501; Email: stephan.landgraff@medicalschool-berlin.de
      • Contact: Rami El Shafie, Prof. Dr. med.; Phone Number: +49 5513964501; Email: rami.elshafie@med.uni-goettingen.de
      • Principal Investigator: Rami El Shafie, Prof. Dr. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Patient Education; Participants receive standard patient education before radiotherapy according to routine clinical practice. Standard patient education comprises the physician consultation covering the indication and aim of radiotherapy, treatment planning and delivery, possible acute and late side effects, and organizational aspects of care. No simulation-based education session is provided. Prescribed oncological treatment and routine radiotherapy care are not altered.
Experimental: Simulation-Based Patient Education; Participants receive standard patient education as in the control arm and, in addition, a single structured simulation-based patient education session after the planning CT and before the first radiotherapy fraction.	Other: Simulation-Based Patient Education; A single, standardized, simulation-based patient education session lasting 15 to 20 minutes, conducted in addition to the standard education session that takes place after the planning CT scan and before the first radiation therapy fraction. This session uses the immersive radiation therapy simulation software VERT 9.0 to visualize the treatment room, the linear accelerator, and the treatment process. In addition to illustrating the treatment process, targeted information is provided to address treatment-specific fears identified as priorities in the Delphi consensus. The session is conducted by the principal investigator following a standardized procedure to ensure comparability among participants. The prescribed oncological treatment and routine radiation therapy remain unchanged.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
State anxiety at the first radiotherapy fraction (STAI-G Form X1)	State anxiety at the first radiotherapy fraction (T2), measured with the state scale (Form X1) of the German version of the State-Trait Anxiety Inventory (STAI-G). The sum score comprises 20 items and ranges from 20 to 80, with higher scores indicating greater state anxiety. The adjusted between-group difference in means at T2 is analyzed by analysis of covariance with the baseline state anxiety score at T0 as a continuous covariate and dichotomized trait anxiety at T0 as a factor. The effect measure is the adjusted mean difference with a 95% confidence interval.	First radiotherapy fraction (T2), approximately 2 weeks after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
State anxiety after the planning CT or education session (STAI-G Form X1)	State anxiety at T1, measured with the state scale (Form X1) of the German version of the State-Trait Anxiety Inventory (STAI-G). Scores range from 20 to 80, with higher scores indicating greater state anxiety. Analyzed by analysis of covariance with the baseline state anxiety score at T0 as a continuous covariate and dichotomized trait anxiety at T0 as a factor.	T1, immediately after the planning CT or after the education session, approximately 1 week after randomization
State anxiety at the fifth radiotherapy fraction (STAI-G Form X1)	State anxiety at T3, measured with the state scale (Form X1) of the German version of the State-Trait Anxiety Inventory (STAI-G). Scores range from 20 to 80, with higher scores indicating greater state anxiety. Analyzed by analysis of covariance with the baseline state anxiety score at T0 as a continuous covariate and dichotomized trait anxiety at T0 as a factor.	Fifth radiotherapy fraction (T3), approximately 3 weeks after randomization
Health-related quality of life: Global Health Status/Quality of Life (EORTC QLQ-C30)	Health-related quality of life at T3, measured with the EORTC QLQ-C30 and linearly transformed to a score from 0 to 100, with higher scores indicating a greater global health status and quality of life. Analyzed by analysis of covariance with group as a factor, the T0 Global Health Status/Quality of Life score as a continuous covariate, and dichotomized trait anxiety at T0 as a factor. Functioning and symptom scales are reported descriptively only.	Fifth radiotherapy fraction (T3), approximately 3 weeks after randomization
Perceived amount of information received: "Information about the treatment" scale (EORTC QLQ-INFO25)	Perceived amount of information received at T1, measured with the multi-item scale "Information about the treatment" (items 38 to 43) of the EORTC QLQ-INFO25 and linearly transformed to a score from 0 to 100, with higher scores indicating a greater perceived amount of information. Groups are compared in a linear model with group as a factor and dichotomized trait anxiety at T0 as the only adjustment variable. The remaining multi-item scales, single items, the total score, and the assessment at T2 are reported descriptively.	T1, immediately after the planning CT or after the education session, approximately 1 week after randomization
Feasibility of the simulation-based patient education intervention	Composite descriptive endpoint with target values defined a priori: recruitment rate of at least 50%, retention rate of at least 80% at T3, protocol adherence of at least 90%, data completeness of at least 85% from T0 to T3, and tolerability defined as discontinuation due to intervention-associated distress reactions in no more than 10% of participants. All rates are reported with two-sided 95% confidence intervals. No formal hypothesis testing is performed.	From enrollment to the fifth radiotherapy fraction (T3), approximately 3 weeks per participant

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Moderation of the intervention effect on state anxiety at T2 by trait anxiety	Dispositional trait anxiety is measured once at baseline (T0) with the trait scale (Form X2) of the German version of the State-Trait Anxiety Inventory (STAI-G) and dichotomized at a threshold of 40 points or higher. The group-by-trait-anxiety interaction term is tested in the analysis of covariance model of the primary endpoint (state anxiety at T2). Dichotomized trait anxiety additionally serves as a stratification factor for randomization and as a prognostic factor in all analyses of state anxiety. This analysis is not independently powered and is interpreted as hypothesis-generating.	First radiotherapy fraction (T2), approximately 2 weeks after randomization
Effect modification of the primary endpoint by prespecified participant and treatment characteristics	Effect modification of state anxiety at T2 by irradiation site (central nervous system, head and neck, breast, thorax, abdomen, pelvis), sex, educational level, and concomitant systemic therapy, assessed via the respective interaction terms with treatment allocation in the model of the primary endpoint. These analyses are not independently powered and are interpreted as hypothesis-generating.	First radiotherapy fraction (T2), approximately 2 weeks after randomization

Collaborators and Investigators

• Sponsor: University Medical Center Goettingen
• Collaborators: Medical School Berlin
• Investigators: Principal Investigator: Rami El Shafie, Prof. Dr. med., Department of Radiotherapy and Radiation Oncology, University Medical Center Goettingen (UMCG); Study Director: Stephan-Peter Landgraff, M.Ed., Faculty of Health Sciences, Medical School Berlin (MSB)

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2028
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: July 17, 2026
• First Submitted That Met QC Criteria: July 17, 2026
• First Posted (Actual): July 23, 2026

Study Record Updates

• Last Update Posted (Actual): August 11, 2026
• Last Update Submitted That Met QC Criteria: August 6, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Quality of Life; Radiotherapy; Patient Education; Simulation Training; Psycho-Oncology; State-Trait Anxiety Inventory; VERT
• Additional Relevant MeSH Terms: Mental Disorders; Neoplasms; Anxiety Disorders
• Other Study ID Numbers: ARAISE-RT-UMG-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared with external researchers. Study data contain sensitive health information and will be stored and analyzed in pseudonymized form on secure institutional servers in accordance with the study protocol and applicable data-protection requirements.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No