Evaluation of Socioeconomic Aspects Before and After Primary Radiation Therapy (Percutaneous or Interstitial or Combined Percutaneous and Interstitial) in Patients With Prostate Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- University of Erlangen-Nürnberg Medical School
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- therapy concerning and follow-up costs associated with changes in social professional situation that is connected with Quality of life
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
therapy concerning and follow-up costs associated with changes in social professional situation that is connected with Quality of life
Time Frame: 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 Outcomes
- 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)