Gynecologic CancerNCT07416630
Web-Based Application for Monitoring Radiation Therapy Complications in Cancer Patients
A study testing Web-Based Application for PROM Monitoring During Radiotherapy in people with Gynecologic Cancer and Urologic Cancer, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gynecologic Cancer, Urologic Cancer, Breast Cancer
- What is being tested?
- Web-Based Application for PROM Monitoring During Radiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSlovenia
- Study dates
- 2 Sep 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Inability to understand the questionnaire questions and provide meaningful answers.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Klavdija Korošec contact
Slovenia1 site, 1 recruiting
- Recruiting
Institute of Oncology Ljubljana
Ljubljana, 1000
Klavdija Korošec, +386 31630065, kkorosec@onko-i.si
About this study
Official title: 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.
Read the 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.
- Conditions
- Gynecologic Cancer, Urologic Cancer, Breast Cancer
- Being tested
- Web-Based Application for PROM Monitoring During Radiotherapy
- Medical subject headings
- Urologic Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-Based Application for PROM Monitoring During RadiotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Web-Based Application for PROM Monitoring During Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- = mild
- = moderate
- = severe
- = 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.
Measured: From baseline (start of radiotherapy) through 2 years after completion of radiotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start2 Sep 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Oncology Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07416630
- Sponsor's protocol ID
- OI-PROM-RT-2023
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Programme for Development and Use of a Web-based Application for Monitornig Complications of Radiation Therapy in Cancer Patients and Analysis of Its Effectiveness
- ClinicalTrials.gov ID
- NCT07416630
- Acronym / sponsor ID
- OI-PROM-RT-2023
- Conditions
- Gynecologic Cancer, Urologic Cancer, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Study start
- 2 Sep 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Web-Based PROM Monitoring During Radiotherapy | Experimental | Other: Web-Based Application for PROM Monitoring During RadiotherapyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Inability to understand the questionnaire questions and provide meaningful answers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-Based Application for PROM Monitoring During RadiotherapyParticipants 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. | Other | Web-Based PROM Monitoring During Radiotherapy |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Klavdija Korošec contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-Based Application for PROM Monitoring During Radiotherapy in people with Gynecologic Cancer and Urologic Cancer, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Barbara Zobec Logar, MD (+38615879273, HLogar@onko-i.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.