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

NCT07721246 | Not Yet Recruiting

• 1 other identifier: ARAISE-RT-UMG-2026
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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, equipment, and 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. This study investigates whether an additional simulation-based patient education session before radiotherapy improves patients' understanding of their treatment and reduces radiotherapy-related state anxiety. Participants receiving radiotherapy will be assigned by chance to one of two groups. All participants will receive the usual patient education provided before radiotherapy. In addition, participants in one group will receive the simulation-based education session before the beginning of the treatment process. The study will compare changes in radiotherapy-related state anxiety and health-related quality of life between the two groups. It will also assess whether the additional education session is feasible, well accepted, and practical to provide as part of routine radiotherapy care.

Conditions

Radiotherapy-Related Anxiety; Patient Education; Psychosocial Effects of Cancer and Its Treatment

Keywords

Radiotherapy; Radiation Therapy; Cancer; Radiotherapy-Related Anxiety; Anxiety; Patient Education; Simulation-Based Education; Quality of Life; VERT; Virtual Environment for Radiotherapy Training; Randomized Controlled Trial; Neoplasms; Feasibility

Outcome Measures

Primary Outcomes (1)

• Change in state anxiety from baseline to first radiotherapy fraction

  Between-group difference in change in state anxiety from baseline to the first radiotherapy fraction, measured using the German version of the State-Trait Anxiety Inventory, State Anxiety scale (STAI-G Form X1). The scale contains 20 items and total scores range from 20 to 80, with higher scores indicating greater state anxiety. Baseline is assessed after the standard radiotherapy information consultation and before randomization (T0).

  Baseline before randomization (T0) to first radiotherapy fraction (T2), approximately 1 to 3 weeks

Secondary Outcomes (3)

• Change in state anxiety from baseline to fifth radiotherapy fraction

  Baseline before randomization (T0) to fifth radiotherapy fraction (T3), approximately 1 to 3 weeks

• Change in health-related quality of life

  Baseline (T0) to first radiotherapy fraction (T2) and fifth radiotherapy fraction (T3), approximately 1 to 3 weeks

• Feasibility and acceptability of simulation-based patient education

  From enrollment to fifth radiotherapy fraction, approximately 3 - 4 weeks per participant

Study Arms (2)

Standard Patient Education

NO INTERVENTION

Participants will receive standard patient education before radiotherapy according to routine clinical practice. Standard education includes the usual medical consultation and information about the planned radiotherapy treatment, treatment procedures, potential side effects, and practical aspects of care. No additional simulation-based education session will be provided.

Simulation-Based Patient Education

EXPERIMENTAL

Participants will receive standard patient education before radiotherapy according to routine clinical practice. In addition, they will receive a structured simulation-based patient education session before the start of radiotherapy.

Other: Simulation-Based Patient Education

Interventions

Simulation-Based Patient Education OTHER

A structured, simulation-based patient education session provided in addition to standard patient education before radiotherapy. The session uses a software-based representation of the radiotherapy setting to familiarise participants with the treatment environment, radiotherapy equipment, treatment procedures, and their individual treatment situation. Where appropriate, participants' own DICOM imaging data may be integrated with virtual patient models to support an individualised visualisation of the planned treatment. The content particularly addresses radiotherapy-related fears, concerns, and information needs identified in the preceding multiprofessional needs assessment and Delphi survey. The session is delivered with support from a member of the radiotherapy care team and does not alter the prescribed cancer treatment or routine radiotherapy care.

Simulation-Based Patient Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Histologically confirmed malignancy
• Planned first course of curative-intent fractionated radiotherapy
• Sufficient German language proficiency
• Written informed consent

You may not qualify if:

• Prior radiotherapy
• Inability to provide informed consent or complete study questionnaires
• Severe psychiatric disorder or cognitive impairment
• Visual impairment that precludes use of the simulation-based programme
• Pregnancy

Sponsors & Collaborators

• University Medical Center Goettingen: lead
• Medical School Berlin: collaborator

MeSH Terms

Conditions

Neoplasms; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Rami El Shafie, Prof. Dr. med.

  Department of Radiation Oncology, University Medical Center Göttingen (UMCG)

  PRINCIPAL INVESTIGATOR

• Stephan-Peter Landgraff

  Faculty of Health Sciences, Medical School Berlin (MSB)

  STUDY DIRECTOR

Central Study Contacts

Stephan-Peter Landgraff

CONTACT

+49 172 8051175; stephan.landgraff@medicalschool-berlin.de

Rami El Shafie, Prof. Dr. med

CONTACT

+49 551 3964501; rami.elshafie@med.uni-goettingen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director, Department of Radiation Oncology (UMCG)

Model Details: This is a prospective, two-arm, parallel-group, randomized, open-label study. Participants will be randomly assigned in a 1:1 ratio to receive either standard patient education alone or standard patient education plus an additional simulation-based patient education session before radiotherapy. The prescribed oncological treatment and routine radiotherapy care will not be altered by study participation.

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: July 23, 2026
• Study Start (Estimated): January 1, 2029
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2030
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share