Prostate Cancer
Conditions
Keywords
socioeconomic aspects, costs of therapy, follow-up costs, primary radiation, percutaneous, interstitial
Brief summary
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.
Interventions
OTHERquestionnaires
patients receive questionnaires regarding socioeconomic aspects before, during and after therapy
Sponsors
University of Erlangen-Nürnberg Medical School
Study design
Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| therapy concerning and follow-up costs associated with changes in social professional situation that is connected with Quality of life | Participants will be followed for the duration of therapy and for 1 year after the last study treatment | by questionnaires concerning social aspects and quality of life to evaluate connections between these parameters |
Secondary
| Measure | 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 |
Countries
Germany
Contacts
Primary ContactAnnedore Strnad, MD, MHBA
Backup ContactRainer Fietkau, MD
Outcome results
None listed