Sense of Coherence and Quality of Life in Prostate Cancer Patients Treated With Radical Radiotherapy (NCT07431684) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Sense of Coherence and Quality of Life in Prostate Cancer Patients Treated With Radical Radiotherapy
Slovenia250 participantsStarted 2021-09-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Health-Related Quality of Life (HRQL)
Timeframe: Baseline (before radiotherapy), end of radiotherapy, and 1 year after completion of radiotherapy