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NCT02293642 Clinical Trial

Bone Pain Score Validation Initiative

Bone Metastasis Clinical Trial

— ARIE  

Official title:
Prospective Epidemiology Study to Validate the BOMET-QoL-10 in Patients With Bone Metastasis in Germany

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02293642
Other study ID # IOM-268
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 2014
Est. completion date June 2016

Study information
Verified date August 2018
Source iOMEDICO AG
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 370
Est. completion date June 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Multiple Sites All Over Germany Multiple Locations

Sponsors (1)
Lead Sponsor Collaborator
iOMEDICO AG

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Marschner N, Wilke J, Reschke D, Kaiser F, Schmoor C, Grugel R, Boller E. A brief instrument to measure health-related quality-of-life in patients with bone metastasis: validation of the German version of Bone Metastases Quality-of-Life-10 (BOMET-QoL-10). — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary QoL Validity and responsiveness of the BOMET-QoL-10 questionnaire in reference to EORTC QLQ-C30/BM-22 6 months
Secondary Impact of characteristics on questionnaire scores Impact of tumour entity, comorbidity and further parameters on the scores of bone metastasis at baseline 6 months
Secondary Sensitivity of questionnaire Sensitivity of BOMET-QoL-10 in patients with / without progression of the disease 6 months
Secondary Sequence effects of questionnaires Influence on the order questionnaires are filled out 6 months
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