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

Prostate Cancer Clinical Trial

— ECOPRO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01849471
• Other study ID #: EP2013
• Status: Recruiting
• Phase: N/A
• First received: April 18, 2013
• Last updated: July 29, 2016
• Start date: April 2013
• Est. completion date: May 2019

Study information

• Verified date: July 2016
• Source: University of Erlangen-Nürnberg Medical School
• Contact: Annedore Strnad, MD, MHBA
• Phone: ++49(0)9131 85
• Email: annedore.strnad[@]uk.erlangen.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• questionnaires
patients receive questionnaires regarding socioeconomic aspects before, during and after therapy

Locations

Country	Name	City	State
Germany	Universitätsklinikum Erlangen	Erlangen

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	adverse events		Participants will be followed for the duration of therapy and for 1 year after the last study treatment	No
Secondary	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	No