Prostate CancerNCT07431684
Sense of Coherence and Quality of Life in Prostate Cancer Patients Treated With Radical Radiotherapy
A study testing Patient-Reported Outcome Assessment (EORTC QLQ-C30, SOC-13, Structured Interview) in people with Prostate Cancer, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
Trial summary
This prospective single-group interventional study evaluates the relationship between sense of coherence (SOC), health-related quality of life (HRQL), and self-rated health (SRH) in patients with prostate cancer treated with radical radiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Patient-Reported Outcome Assessment (EORTC QLQ-C30, SOC-13, Structured Interview)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Sep 2021to 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients aged 18 years and older
- Histologically confirmed prostate cancer
- Planned for radical radiotherapy treatment
- Ability to understand and complete questionnaires independently
- Written informed consent provided
Who cannot join
- Previous radiotherapy for prostate cancer
- Metastatic disease at the time of enrollment
- Any condition that, in the investigator's opinion, would interfere with study participation or data quality
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Association of Sense of Coherence and Health-Related Quality of Life and Self-Rated Health in Patients With Prostate Cancer Treated With Radical Radiotherapy
This prospective single-group interventional study evaluates the relationship between sense of coherence (SOC), health-related quality of life (HRQL), and self-rated health (SRH) in patients with prostate cancer treated with radical radiotherapy. The study aims to identify factors that may contribute to improved quality of life and coping after treatment.
Participants complete validated questionnaires assessing HRQL (EORTC QLQ-C30), SOC (SOC-13), and self-rated health at predefined time points. In addition, objectively assessed treatment-related problems are evaluated using a structured physician-led interview. Data are collected before the start of radiotherapy, at the end of radiotherapy, and one year after completion of treatment.
Read the detailed description
Health-related quality of life (HRQL) is an important clinical outcome in oncology, particularly in patients with prostate cancer, who often experience long survival and treatment-related side effects. Psychological and social factors may influence the way patients cope with cancer diagnosis and treatment. The concept of salutogenesis, introduced by Antonovsky, emphasizes factors that support health and adaptation, with sense of coherence (SOC) representing a key internal resource for coping with stressful life events.
This prospective single-group interventional clinical study investigates the relationship between SOC and HRQL, self-rated health (SRH), and objectively assessed treatment-related problems in patients with prostate cancer treated with radical radiotherapy.
The study is conducted at the Institute of Oncology Ljubljana. Patients are assessed at three time points: before initiation of radical radiotherapy, at the end of radiotherapy, and one year after completion of treatment. HRQL is measured using the EORTC QLQ-C30 questionnaire (version 3), SOC is measured using the SOC-13 questionnaire, and SRH is evaluated through patient self-assessment. Objective treatment-related problems, including urinary and bowel symptoms, are assessed using a structured physician-led interview. Additional clinical data regarding treatment type and comorbidities are collected from medical records.
The main objectives are to describe SOC, HRQL, SRH, and objectively assessed treatment-related problems over time, and to evaluate correlations between these variables. Statistical analyses will include descriptive statistics, repeated measures analysis, correlation and regression methods, and multivariable models to adjust for relevant clinical and demographic factors.
The study is expected to provide new evidence on psychosocial factors associated with quality of life outcomes in prostate cancer patients treated with radical radiotherapy and may support development of patient-centered supportive interventions.
- Conditions
- Prostate Cancer
- Being tested
- Patient-Reported Outcome Assessment (EORTC QLQ-C30, SOC-13, Structured Interview)
- Keywords
- Sense of Coherence, Health-Related Quality of Life
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-Reported Outcome Assessment (EORTC QLQ-C30, SOC-13, Structured Interview)Other
Participants complete validated questionnaires (EORTC QLQ-C30 version 3 and SOC-13) and undergo a structured physician-led interview to assess self-rated health and treatment-related problems. Assessments are performed before radiotherapy, at the end of radiotherapy, and one year after completion of radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Radical Radiotherapy With Patient-Reported Outcome Assessment | Experimental | Participants with prostate cancer treated with radical radiotherapy complete validated questionnaires assessing sense of coherence (SOC-13), health-related quality of life (EORTC QLQ-C30), and self-rated health at predefined time points. Objective treatment-related problems are assessed using a structured physician-led interview before treatment, at the end of radiotherapy, and one year after completion of radiotherapy. Receives: Other: Patient-Reported Outcome Assessment (EORTC QLQ-C30, SOC-13, Structured Interview) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-Related Quality of Life (HRQL)
Health-related quality of life assessed using the validated EORTC QLQ-C30 questionnaire (version 3). The EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30) is a standardized, patient-reported outcome measure developed by the EORTC Quality of Life Group to evaluate health-related quality of life in individuals with cancer. Interpretation:
Functional scales: Higher scores = better functioning Symptom scales: Higher scores = more severe symptoms Global health status: Higher scores = better overall quality of life This scoring system allows researchers and clinicians to quantify patient-reported outcomes, compare across studies, and monitor changes over time.
Measured: Baseline (before radiotherapy), end of radiotherapy, and 1 year 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 posted24 Feb 2026
- Study start1 Sep 2021
- Primary completion1 Sep 2023
- 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 Prostate 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
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
- NCT07431684
- Sponsor's protocol ID
- OI-LJ-PRO-SOC-HRQL-2021
- Other IDs
- 0120-312/2021/3
- Status last verified
- Feb 2026
- First submitted
- 19 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association of Sense of Coherence and Health-Related Quality of Life and Self-Rated Health in Patients With Prostate Cancer Treated With Radical Radiotherapy
- ClinicalTrials.gov ID
- NCT07431684
- Acronym / sponsor ID
- OI-LJ-PRO-SOC-HRQL-2021
- Conditions
- Prostate Cancer
- Keywords
- Sense of Coherence, Health-Related Quality of Life
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 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.
This prospective single-group interventional study evaluates the relationship between sense of coherence (SOC), health-related quality of life (HRQL), and self-rated health (SRH) in patients with prostate cancer treated with radical radiotherapy. The study aims to identify factors that may contribute to improved quality of life and coping after treatment.
Participants complete validated questionnaires assessing HRQL (EORTC QLQ-C30), SOC (SOC-13), and self-rated health at predefined time points. In addition, objectively assessed treatment-related problems are evaluated using a structured physician-led interview. Data are collected before the start of radiotherapy, at the end of radiotherapy, and one year after completion of treatment.
Detailed description
Health-related quality of life (HRQL) is an important clinical outcome in oncology, particularly in patients with prostate cancer, who often experience long survival and treatment-related side effects. Psychological and social factors may influence the way patients cope with cancer diagnosis and treatment. The concept of salutogenesis, introduced by Antonovsky, emphasizes factors that support health and adaptation, with sense of coherence (SOC) representing a key internal resource for coping with stressful life events.
This prospective single-group interventional clinical study investigates the relationship between SOC and HRQL, self-rated health (SRH), and objectively assessed treatment-related problems in patients with prostate cancer treated with radical radiotherapy.
The study is conducted at the Institute of Oncology Ljubljana. Patients are assessed at three time points: before initiation of radical radiotherapy, at the end of radiotherapy, and one year after completion of treatment. HRQL is measured using the EORTC QLQ-C30 questionnaire (version 3), SOC is measured using the SOC-13 questionnaire, and SRH is evaluated through patient self-assessment. Objective treatment-related problems, including urinary and bowel symptoms, are assessed using a structured physician-led interview. Additional clinical data regarding treatment type and comorbidities are collected from medical records.
The main objectives are to describe SOC, HRQL, SRH, and objectively assessed treatment-related problems over time, and to evaluate correlations between these variables. Statistical analyses will include descriptive statistics, repeated measures analysis, correlation and regression methods, and multivariable models to adjust for relevant clinical and demographic factors.
The study is expected to provide new evidence on psychosocial factors associated with quality of life outcomes in prostate cancer patients treated with radical radiotherapy and may support development of patient-centered supportive interventions.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radical Radiotherapy With Patient-Reported Outcome Assessment | Experimental | Other: Patient-Reported Outcome Assessment (EORTC QLQ-C30, SOC-13, Structured Interview)Participants with prostate cancer treated with radical radiotherapy complete validated questionnaires assessing sense of coherence (SOC-13), health-related quality of life (EORTC QLQ-C30), and self-rated health at predefined time points. Objective treatment-related problems are assessed using a structured physician-led interview before treatment, at the end of radiotherapy, and one year after completion of radiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male patients aged 18 years and older
- Histologically confirmed prostate cancer
- Planned for radical radiotherapy treatment
- Ability to understand and complete questionnaires independently
- Written informed consent provided
Key exclusion criteria (3 listed)
- Previous radiotherapy for prostate cancer
- Metastatic disease at the time of enrollment
- Any condition that, in the investigator's opinion, would interfere with study participation or data quality
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 |
|---|---|---|
| Patient-Reported Outcome Assessment (EORTC QLQ-C30, SOC-13, Structured Interview)Participants complete validated questionnaires (EORTC QLQ-C30 version 3 and SOC-13) and undergo a structured physician-led interview to assess self-rated health and treatment-related problems. Assessments are performed before radiotherapy, at the end of radiotherapy, and one year after completion of radiotherapy. | Other | Radical Radiotherapy With Patient-Reported Outcome Assessment |
Primary outcome
Health-Related Quality of Life (HRQL)
Time frame: Baseline (before radiotherapy), end of radiotherapy, and 1 year after completion of radiotherapy
Health-related quality of life assessed using the validated EORTC QLQ-C30 questionnaire (version 3). The EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30) is a standardized, patient-reported outcome measure developed by the EORTC Quality of Life Group to evaluate health-related quality of life in individuals with cancer. Interpretation: Functional scales: Higher scores = better functioning Symptom scales: Higher scores = more severe symptoms Global health status: Higher scores = better overall quality of life This scoring system allows researchers and clinicians to quantify patient-reported outcomes, compare across studies, and monitor changes over time.
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 3 Mar 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient-Reported Outcome Assessment (EORTC QLQ-C30, SOC-13, Structured Interview) in people with Prostate 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 5 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 3 Mar 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-Related Quality of Life (HRQL) (time frame: Baseline (before radiotherapy), end of radiotherapy, and 1 year 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 3 Mar 2026.