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Bone Pain Score Validation Initiative (ARIE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02293642
Recruitment Status : Completed
First Posted : November 18, 2014
Last Update Posted : August 10, 2018
Sponsor:
Information provided by (Responsible Party):
iOMEDICO AG

Brief Summary:
Translation and validation of the BOMET-QoL-10 questionnaire in Germany and assessment of its validity and responsiveness.

Condition or disease
Bone Metastasis

Detailed Description:
Aim of this study is to translate the questionnaire and to examine the psychometric properties of BOMET-QoL-10 in a German population. Correlations with the EORTC QLQ-C30/BM22 at the time of enrolment and throughout the study aim to verify that the BOMET-QoL-10 is reliable, valid and able to detect stabilization or changes in quality of life.

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Study Type : Observational
Actual Enrollment : 370 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Epidemiology Study to Validate the BOMET-QoL-10 in Patients With Bone Metastasis in Germany
Study Start Date : December 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. QoL [ Time Frame: 6 months ]
    Validity and responsiveness of the BOMET-QoL-10 questionnaire in reference to EORTC QLQ-C30/BM-22


Secondary Outcome Measures :
  1. Impact of characteristics on questionnaire scores [ Time Frame: 6 months ]
    Impact of tumour entity, comorbidity and further parameters on the scores of bone metastasis at baseline

  2. Sensitivity of questionnaire [ Time Frame: 6 months ]
    Sensitivity of BOMET-QoL-10 in patients with / without progression of the disease

  3. Sequence effects of questionnaires [ Time Frame: 6 months ]
    Influence on the order questionnaires are filled out



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:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with bone metastases from primary cancers of the breast, kidney, lung or prostate
Criteria

Inclusion Criteria:

  • Male or female adults patients (≥ 18 years)
  • Diagnosed cancer of the breast, kidney, lung or prostate
  • Bone metastases
  • Estimated life expectancy of at least 6 months
  • Fluent German speaking, reading and writing
  • Informed written consent

Exclusion Criteria:

  • Patients without bone metastases
  • Participation in another study involving questionnaires
  • Patients not able to comply with the assessments specified in the protocol

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): NCT02293642


Locations
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Germany
Multiple Sites All Over Germany
Multiple Locations, Germany
Sponsors and Collaborators
iOMEDICO AG
Investigators
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Principal Investigator: Norbert Marschner, MD Outpatient Centre for Interdisciplinary Oncology and Haematology, D-Freiburg
Publications of Results:
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Responsible Party: iOMEDICO AG
ClinicalTrials.gov Identifier: NCT02293642    
Other Study ID Numbers: IOM-268
First Posted: November 18, 2014    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by iOMEDICO AG:
primary cancers of the breast
primary cancers of the kidney
primary cancers of the lung
primary cancers of the prostate
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes