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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Medical Center Goettingen

About this trial

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.

Eligibility criteria

Qualifiers

Age 18 years or older

Histologically or cytologically confirmed malignant tumor disease

Stage I - III (UICC TNM classification)

ECOG performance status ≤ 2

Disqualifiers

Lack of capacity to provide informed consent

Pregnancy or breastfeeding

Stereotactic radiotherapy

Emergency treatment indication

Trial design

Treatments tested in this trial

  • Simulation-Based Patient Education

Treatment groups

144 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University Medical Center Goettingen

Lead sponsor

Medical School Berlin

Collaborator