Web-Based Application for Monitoring Radiation Therapy Complications in Cancer Patients

February 20, 2026 updated by: Institute of Oncology Ljubljana

Programme for Development and Use of a Web-based Application for Monitornig Complications of Radiation Therapy in Cancer Patients and Analysis of Its Effectiveness

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Radiotherapy is an essential modality in cancer treatment, but it may cause acute and chronic adverse effects. Effective detection of complications during radiotherapy is crucial for timely clinical response, prevention of long-term consequences, and improvement of patient quality of life. Patient-reported outcome measures (PROMs) are widely used internationally and increasingly implemented in electronic form.

This prospective clinical study aims to develop and implement a web-based application that enables cancer patients to report radiotherapy-related complications and quality of life outcomes through standardized electronic questionnaires. The application will support remote monitoring and allow healthcare professionals to optimize clinical workload and reduce unnecessary outpatient visits.

Patients treated with radiotherapy at the Institute of Oncology Ljubljana will be invited to participate. Before inclusion, patients will sign written informed consent and will receive instructions regarding application use. During radiotherapy, patients will complete electronic questionnaires weekly until completion of treatment. After radiotherapy, patients will complete questionnaires before each scheduled follow-up visit during the first two years.

Questionnaires will be transmitted securely via HTTPS to a database at the Institute of Oncology Ljubljana. Patient responses will be categorized into three severity groups using a traffic-light system: green (grade 1), yellow (grade 2), and red (grade 3). Patients in the red category will be contacted and scheduled for an early clinical visit, patients in the yellow category will be monitored more frequently, and patients in the green category will be reviewed at the end of radiotherapy and at regular follow-up appointments.

The study will evaluate the appropriateness of questionnaires and responses for prediction of radiotherapy-related adverse effects. Patient-reported symptom severity will be compared with physician-reported toxicity grading. Quality of life outcomes and healthcare service utilization will also be assessed. The application will be evaluated using performance indicators such as accuracy, sensitivity, and specificity. Statistical analysis will include descriptive statistics, frequency distributions, and linear mixed-effects models for quality of life evaluation.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Barbara Zobec Logar, MD
  • Phone Number: +38615879273
  • Email: HLogar@onko-i.si

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Recruiting
        • Institute of Oncology Ljubljana
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Inability to understand the questionnaire questions and provide meaningful answers.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Web-Based PROM Monitoring During Radiotherapy
Participants undergoing radiotherapy use a web-based application to complete standardized electronic questionnaires weekly during radiotherapy and prior to scheduled follow-up visits after treatment. Responses are categorized using a traffic-light system to guide clinical actions and improve management of radiotherapy-related complications.
Other: Web-Based Application for PROM Monitoring During Radiotherapy
Participants 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prediction of Radiotherapy-Related Adverse Effects Using Electronic Patient-Reported Outcome Measures (PROMs)
Time Frame: From baseline (start of radiotherapy) through 2 years after completion of radiotherapy.

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.
From baseline (start of radiotherapy) through 2 years after completion of radiotherapy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Oncology Ljubljana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 10, 2026

First Submitted That Met QC Criteria

February 10, 2026

First Posted (Actual)

February 18, 2026

Study Record Updates

Last Update Posted (Actual)

February 24, 2026

Last Update Submitted That Met QC Criteria

February 20, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OI-PROM-RT-2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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