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

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ClinicalTrials.gov Identifier: NCT01849471
Recruitment Status : Unknown
Verified July 2016 by University of Erlangen-Nürnberg Medical School.
Recruitment status was:  Recruiting
First Posted : May 8, 2013
Last Update Posted : August 1, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Prostate Cancer Other: questionnaires

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
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
Study Start Date : April 2013
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. adverse events [ Time Frame: Participants will be followed for the duration of therapy and for 1 year after the last study treatment ]
  2. correlation of quality of life, adverse events and economic aspects for the patient and the health insurance coverage [ Time Frame: Participants will be followed for the duration of therapy and for 1 year after the last study treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Men with prostata cancer that receive primary radiation therapy
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01849471


Contacts
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Contact: Annedore Strnad, MD, MHBA ++49(0)9131 85 ext 33968 annedore.strnad@uk.erlangen.de
Contact: Rainer Fietkau, MD ++49(0)9131 85 ext 33968 st-studiensekretariat@uk-erlangen.de

Locations
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Germany
Universitätsklinikum Erlangen Recruiting
Erlangen, Germany, 91054
Contact: Annedore Strnad, MD, MHBA    ++49(0) 9131 85 ext 33968    annedore.strand@uk-erlangen.de   
Contact: Rainer Fietkau, MD    ++49(0) 9131 85 ext 33968    st-studiensekretariat@uk-erlangen.de   
Principal Investigator: Annedore Strnad, MD, MHBA         
Sub-Investigator: Rainer Fietkau, MD         
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
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Principal Investigator: Annedore Strnad, MD, MHBA Strahlenklinik, Universitätsklinikum Erlangen
Study Director: Rainer Fietkau, MD Strahlenklinik, Universitätsklinikum Erlangen

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Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT01849471     History of Changes
Other Study ID Numbers: EP2013
First Posted: May 8, 2013    Key Record Dates
Last Update Posted: August 1, 2016
Last Verified: July 2016

Keywords provided by University of Erlangen-Nürnberg Medical School:
socioeconomic aspects
costs of therapy
follow-up costs
primary radiation
percutaneous
interstitial

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases