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

NCT07431684 | Active Not Recruiting

• 2 other identifiers: OI-LJ-PRO-SOC-HRQL-20210120-312/2021/3
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

Sense of Coherence; Health-Related Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (before radiotherapy), end of radiotherapy, and 1 year after completion of radiotherapy

Study Arms (1)

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.

Other: Patient-Reported Outcome Assessment (EORTC QLQ-C30, SOC-13, Structured Interview)

Interventions

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.

Radical Radiotherapy With Patient-Reported Outcome Assessment

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: February 24, 2026
• Study Start: September 1, 2021
• Primary Completion: September 1, 2023
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)