Trial document





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

  DRKS00006402

Trial Description

start of 1:1-Block title

Title

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

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

ECOPRO

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

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.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

[---]*

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

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

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00006402
  •   2014/11/28
  •   2013/04/18
  •   yes
  •   [---]*
  •   [---]*
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   NCT01849471  (ClinicalTrials.gov)
  •   EP2013  (University of Erlangen-Nürnberg Medical School)
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Prostate Cancer
  •   C61 -  Malignant neoplasm of prostate
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Other: questionnaires
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   [---]*
  •   [---]*
  •   [---]*
  •   [---]*
  •   [---]*
  •   [---]*
  •   N/A
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

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

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

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

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  •  
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   [---]*
  •   2013/04/30
  •   60
  •   [---]*
  •   [---]*
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- minimal age 18

- low, mediate and high-grade prostate cancer

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

- tumor recurrence

- surgery as primary therapy

- prior radiotherapy except conventional radiotherapy

- patients with other malignancies

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • University of Erlangen-Nürnberg Medical School
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Strahlenklinik, Universitätsklinikum Erlangen
    • Annedore Strnad, MD, MHBA 
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Annedore Strnad, MD, MHBA 
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
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.