Trial document




This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006402

Trial Description

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Title

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

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Trial Acronym

ECOPRO

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00006402
  •   2014/11/28
  •   2013/04/18
  •   yes
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Secondary IDs

  •   NCT01849471  (ClinicalTrials.gov)
  •   EP2013  (University of Erlangen-Nürnberg Medical School)
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Health Condition or Problem studied

  •   Prostate Cancer
  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Other: questionnaires
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Characteristics

  •   Non-interventional
  •   Observational study
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  •   N/A
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Primary Outcome

- 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

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Secondary Outcome

- adverse events; time frame: 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; time frame: Participants will be followed for the duration of therapy and for 1 year after the last study treatment

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2013/04/30
  •   60
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- minimal age 18

- low, mediate and high-grade prostate cancer

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Exclusion Criteria

- tumor recurrence

- surgery as primary therapy

- prior radiotherapy except conventional radiotherapy

- patients with other malignancies

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Addresses

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    • University of Erlangen-Nürnberg Medical School
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    • Strahlenklinik, Universitätsklinikum Erlangen
    • Annedore Strnad, MD, MHBA 
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    • Annedore Strnad, MD, MHBA 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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Additional Trial Attributes

  • Urological disease 
  • If other, please specify 
  • Study recommendations 
  • If other, please specify 
  • German director of clinical investigation 
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    • [---]*
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  • Further contact 
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  • Function of contact 
  • Non-interventional study 
  • Stage 
  • If other, please specify 
  • Onset of therapy 
  • If other, please specify 
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   3
  •   2016/01/14
* This entry means the parameter is not applicable or has not been set.