Bone Metastasis Clinical Trial
— ARIEOfficial title:
Prospective Epidemiology Study to Validate the BOMET-QoL-10 in Patients With Bone Metastasis in Germany
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 |
Verified date | August 2018 |
Source | iOMEDICO AG |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Translation and validation of the BOMET-QoL-10 questionnaire in Germany and assessment of its validity and responsiveness.
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Multiple Sites All Over Germany | Multiple Locations |
Lead Sponsor | Collaborator |
---|---|
iOMEDICO AG |
Germany,
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
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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