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This trial is an interrogation of patients with prostate cancer to evaluate socioeconomic effects of radiotherapy. Patients with percutaneous or interstitial or combined percutaneous and interstitial radiotherapy are included. Beside medical effects and adverse events, it's prospectively needed to extensively inform patients about socioeconomic aspects associated with radiotherapy. The interrogation comprises to collect possible costs and expenditures during and after therapy. Aspects especially concerning post therapy period include additional consultations, individual applied alternative medical care, need for additional medical aids (salves, medicine, bandages) and changes in professional and social situation. It's figured out in what extend costs are absorbed by health insurance coverage. In Germany there is no appropriate trial with respective patient population and respective therapy. Primary endpoint is the evaluation of therapy concerning and follow-up costs as well as changes in social and professional situation. Secondary endpoints are quality of life, adverse events of therapy and the correlation of quality of life, adverse events and economic aspects for the patient and the health insurance coverage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with prostate cancer | questionnaires |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| questionnaires | Other | patients receive questionnaires regarding socioeconomic aspects before, during and after therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| therapy concerning and follow-up costs associated with changes in social professional situation that is connected with Quality of life | by questionnaires concerning social aspects and quality of life to evaluate connections between these parameters | Participants will be followed for the duration of therapy and for 1 year after the last study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| adverse events | Participants will be followed for the duration of therapy and for 1 year after the last study treatment | |
| correlation of quality of life, adverse events and economic aspects for the patient and the health insurance coverage | Participants will be followed for the duration of therapy and for 1 year after the last study treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Men with prostata cancer that receive primary radiation therapy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Annedore Strnad, MD, MHBA | Contact | ++49(0)9131 85 | 33968 | annedore.strnad@uk.erlangen.de |
| Rainer Fietkau, MD | Contact | ++49(0)9131 85 | 33968 | st-studiensekretariat@uk-erlangen.de |
| Name | Affiliation | Role |
|---|---|---|
| Annedore Strnad, MD, MHBA | Strahlenklinik, Universitätsklinikum Erlangen | Principal Investigator |
| Rainer Fietkau, MD | Strahlenklinik, Universitätsklinikum Erlangen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Erlangen | Recruiting | Erlangen | 91054 | Germany |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |