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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 2, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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