Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07721246 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: ARAISE
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 9 months later Jul 2029 → May 2030
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from University Medical Center Goettingen

Record History

  1. Primary completion pushed from Jul 2029 to May 2030 Primary endpoint(s) modified · Enrollment increased: 120 → 144 participants · Completion pushed from Jul 2030 to Dec 2030 · 6 morev2 Show 9 more changesShow less
    • Primary endpoint(s) modified
    • Enrollment increased: 120 → 144 participants
    • Completion pushed from Jul 2030 to Dec 2030
    • Study sites: 0 to 1
    • Start date: Jan 2029 to Jan 2028
    • Eligibility criteria expanded, about 85 words
    • Secondary endpoints: 3 to 5
    • Study description shortened, about 27 words
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07721246
Lead Sponsor University Medical Center Goettingen
Collaborators: Medical School Berlin
Conditions Neoplasms, Anxiety
Enrollment 144 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov