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

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

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.

Study Overview

• Status: Unknown
• Conditions: Prostate Cancer
• Intervention / Treatment: Other: questionnaires

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• Germany
  • Erlangen, Germany, 91054
    • Recruiting
    • Universitatsklinikum Erlangen
    • Contact: Annedore Strnad, MD, MHBA; Phone Number: 33968 ++49(0) 9131 85; Email: annedore.strand@uk-erlangen.de
    • Contact: Rainer Fietkau, MD; Phone Number: 33968 ++49(0) 9131 85; Email: st-studiensekretariat@uk-erlangen.de
    • Principal Investigator: Annedore Strnad, MD, MHBA
    • Sub-Investigator: Rainer Fietkau, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Men with prostata cancer that receive primary radiation therapy

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Ecologic or Community
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with prostate cancer; questionnaires	Other: questionnaires; patients receive questionnaires regarding socioeconomic aspects before, during and after therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg Medical School
• Investigators: Principal Investigator: Annedore Strnad, MD, MHBA, Strahlenklinik, Universitätsklinikum Erlangen

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Anticipated): May 1, 2019
• Study Completion (Anticipated): May 1, 2019

Study Registration Dates

• First Submitted: April 18, 2013
• First Submitted That Met QC Criteria: May 3, 2013
• First Posted (Estimate): May 8, 2013

Study Record Updates

• Last Update Posted (Estimate): August 1, 2016
• Last Update Submitted That Met QC Criteria: July 29, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: socioeconomic aspects; costs of therapy; follow-up costs; primary radiation; percutaneous; interstitial
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: EP2013

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No