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Simulation-Based Patient Education to Address Radiotherapy-Related Anxiety in Cancer Patients (ARAISE)
Sponsor: University Medical Center Goettingen
Summary
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
144
Start Date
2028-01
Completion Date
2030-12
Last Updated
2026-08-11
Healthy Volunteers
No
Interventions
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.
Locations (1)
Department of Radiotherapy and Radiation Oncology, University Medical Center Goettingen
Göttingen, Lower Saxony, Germany