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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Simulation-Based Patient Education
Other interventionA 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
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.
Other outcomes
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.
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.
Sponsors and contacts
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University Medical Center Goettingen
Lead sponsor
Medical School Berlin
Collaborator
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