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

Sponsor
University Medical Center Goettingen
Study ID
NCT07721246
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Anxiety
  • Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Simulation-Based Patient Education — OTHER
    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.

Study Details

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.

Key Dates

First listed
Jul 23, 2026
Start date
Jan 31, 2028
Status verified
Aug 2026
Primary completion
May 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
144 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.

Primary Outcome Measure

State anxiety at the first radiotherapy fraction (STAI-G Form X1) [ Time Frame: First radiotherapy fraction (T2), approximately 2 weeks after randomization ]

Central Contacts

Related Studies