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

• Conditions: Prostate Cancer
• Interventions: Other: questionnaires

• Registration Number: NCT01849471
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-18
• Study First Submitted QC: 2013-05-03
• Study First Posted: 2013-05-08
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-29
• Last Update Posted: 2016-08-01
• Primary Completion: 2019-05
• Study Completion: 2019-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with prostate cancer	questionnaires	questionnaires

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Universitätsklinikum Erlangen; 🇩🇪 Erlangen, Germany