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NCT Number: NCT07431684

Sense of Coherence and Quality of Life in Prostate Cancer Patients 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Institute of Oncology Ljubljana

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2026
First posted
Feb 24, 2026
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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