NCT07431684

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Institute of Oncology Ljubljana · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-09-01
• Primary completion: 2023-09-01
• Completion: 2026-12-31
• First posted: 2026-02-24
• Last updated: 2026-03-03

Locations

1 site across 1 country: Slovenia