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

NCT07416630 | Recruiting

• 1 other identifier: OI-PROM-RT-2023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gynecologic Cancer; Urologic Cancer; Breast Cancer

Outcome Measures

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.

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

Study Arms (1)

Web-Based PROM Monitoring During Radiotherapy

EXPERIMENTAL

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

Interventions

Web-Based Application for PROM Monitoring During Radiotherapy OTHER

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.

Web-Based PROM Monitoring During Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

RECRUITING

MeSH Terms

Conditions

Urologic Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Barbara Zobec Logar, MD

CONTACT

+38615879273; HLogar@onko-i.si

Klavdija Korošec

CONTACT

kkorosec@onko-i.si

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants use a web-based application to complete standardized electronic PROM questionnaires during radiotherapy and follow-up, enabling structured monitoring of radiotherapy-related complications and quality of life.

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 18, 2026
• Study Start: September 2, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

SL (1)