Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00008807

Trial Description

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Title

Open-labeled, Multicenter, Non-interventional Prospective PRO/QoL Registry for Patients With Osteoprotective Treatment for Bone Metastases of Breast or Prostate Cancer

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Trial Acronym

PROBone

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Evaluation of patient reported outcomes (PRO) / QoL regarding typical ailments in real-life
patients with bone metastases treated with osteoprotective agents.

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Brief Summary in Scientific Language

The PRO Bone project will recruit a representative cohort of patients with breast or
prostate cancer suffering from bone metastases. The aim of this study is to collect data on
Patient Reported Outcomes (PRO)/Quality of Life regarding bone pain and the impact of bone
pain on quality of life and daily activities. PROs are assessed by a questionnaire
consisting of a visual analog scale for bone pain, two questions regarding bone pain
management, the bone pain module of FACT questionnaire (FACT-BP) and four questions
addressing the impact of treatment on daily life (overall, social life, ability to work and
ability to perform routine tasks)

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Organizational Data

  •   DRKS00008807
  •   2015/06/25
  •   2014/12/23
  •   no
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Secondary IDs

  •   NCT02410044  (ClinicalTrials.gov)
  •   IOM - 11279  (iOMEDICO AG)
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Health Condition or Problem studied

  •   Breast Cancer
  •   Prostate Cancer
  •   Bone Metastases
  •   C61 -  Malignant neoplasm of prostate
  •   C50 -  Malignant neoplasm of breast
  •   C79.5 -  Secondary malignant neoplasm of bone and bone marrow
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Interventions/Observational Groups

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Characteristics

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

- Patient Reported Outcomes (PRO) regarding bone pain and the impact of bone pain on quality of life and daily activities in patients with bone metastases treated with osteoprotective agents.; time frame: 12 months

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Secondary Outcome

- Patient Reported Outcomes regarding the impact of treatment on daily life; time frame: 12 months

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2014/12/31
  •   500
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Histologically confirmed metastatic breast or prostate cancer

- Start of first systemic osteoprotective treatment

- Ability to read and understand German

- Written informed consent

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Exclusion Criteria

• None

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Addresses

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    • iOMEDICO AG
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    • medical practise for oncology
    • Andreas Jakob, MD 
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    • Gerlinde Bing 
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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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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.