Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Patient-Reported Outcome Assessment (EORTC QLQ-C30, SOC-13, Structured Interview) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radical Radiotherapy With Patient-Reported Outcome Assessment
- description
- 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.
- interventionNames
- Other: Patient-Reported Outcome Assessment (EORTC QLQ-C30, SOC-13, Structured Interview)
Primary outcomes (1)
- measure
- Health-Related Quality of Life (HRQL)
- timeFrame
- Baseline (before radiotherapy), end of radiotherapy, and 1 year after completion of radiotherapy
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available