Web-Based Application for Monitoring Radiation Therapy Complications in Cancer Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Oncology Ljubljana
About this trial
Cancer treatment is multidisciplinary and may include radiotherapy. Treatment-related complications represent a burden for patients and the healthcare system. Early recognition of radiotherapy-related side effects is important for timely clinical interventions and improved quality of care. This study aims to improve comprehensive patient management during and after radiotherapy through development and implementation of a web-based application using standardized electronic patient-reported outcome questionnaires (PROMs). Patients will report radiotherapy-related symptoms and quality of life through web-based questionnaires that will be securely transmitted to the Institute of Oncology Ljubljana for review by healthcare professionals. Responses will be categorized using a traffic-light system to guide clinical actions and optimize follow-up visits.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients receiving radiotherapy for gynecologic cancer, urologic cancer, or breast cancer at the Institute of Oncology Ljubljana.
Ability to access and use the web-based application on a smartphone, computer, or tablet.
Signed written informed consent.
Disqualifiers
Inability to understand the questionnaire questions and provide meaningful answers.
Trial design
Design model
Single group
Treatments tested in this trial
Web-Based Application for PROM Monitoring During Radiotherapy
Other interventionParticipants use a web-based application to complete standardized electronic PROM questionnaires on radiotherapy-related side effects and quality of life. Data are securely transmitted to the Institute of Oncology Ljubljana, reviewed by healthcare professionals, and used for clinical triage and optimization of follow-up visits.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Web-Based PROM Monitoring During RadiotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Prediction of Radiotherapy-Related Adverse Effects Using Electronic Patient-Reported Outcome Measures (PROMs)
The predictive validity of electronic patient-reported outcome measures (PROMs) for radiotherapy-related adverse effects will be evaluated. Patient-reported symptom severity will be assessed using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). PRO-CTCAE items are scored on a 5-point numeric scale ranging from 0 to 4 (minimum value = 0; maximum value = 4), where: 0 = none 1. = mild 2. = moderate 3. = severe 4. = very severe Higher scores indicate greater symptom severity (worse outcome). Physician-reported toxicity will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, graded from 1 to 5 (minimum value = 1; maximum value = 5), where higher grades indicate more severe toxicity. Agreement and association between PRO-CTCAE scores and CTCAE grades will be analyzed to determine the predictive performance of electronic PROM monitoring.
Time frame
From baseline (start of radiotherapy) through 2 years after completion of radiotherapy.Sponsors and contacts
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Source ClinicalTrials.gov