Skip to main content
Clinical Trials/NCT01849471
NCT01849471
Unknown
Not Applicable

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

University of Erlangen-Nürnberg Medical School1 site in 1 country60 target enrollmentApril 2013
ConditionsProstate 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.

Registry
clinicaltrials.gov
Start Date
April 2013
End Date
May 2019
Last Updated
9 years ago
Study Type
Observational
Sex
Male

Investigators

Sponsor
University of Erlangen-Nürnberg Medical School
Responsible Party
Sponsor

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)

Study Sites (1)

Loading locations...

Similar Trials