Sense of Coherence and Quality of Life in Prostate Cancer Patients Treated With Radical Radiotherapy

February 27, 2026 updated by: Institute of Oncology Ljubljana

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

250

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 Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Institute of Oncology Ljubljana

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:

  • 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

Exclusion Criteria:

  • 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

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: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Radical Radiotherapy With Patient-Reported Outcome Assessment
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (before radiotherapy), end of radiotherapy, and 1 year 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 1, 2021

Primary Completion (Actual)

September 1, 2023

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 19, 2026

First Submitted That Met QC Criteria

February 19, 2026

First Posted (Actual)

February 24, 2026

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

February 27, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OI-LJ-PRO-SOC-HRQL-2021
  • 0120-312/2021/3 (Other Identifier: Institute of Oncology Ljubljana)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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