Socioeconomic Aspects Before and After Radiation Therapy in Patient With Prostate Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Socioeconomic Aspects Before and After Primary Radiation Therapy (Percutaneous or Interstitial or Combined Percutaneous and Interstitial) in Patients With Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Other: questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: minimal age 18 low, mediate and high-grade prostate cancer Exclusion Criteria: tumor recurrence surgery as primary therapy prior radiotherapy except conventional radiotherapy patients with other malignancies

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with prostate cancer<br>questionnaires | Other: questionnaires<br>* patients receive questionnaires regarding socioeconomic aspects before, during and after therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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socioeconomic aspects, costs of therapy, follow-up costs, primary radiation, percutaneous, interstitial