Bone Pain Score Validation Initiative
- Conditions
- Bone Metastasis
- Registration Number
- NCT02293642
- Lead Sponsor
- iOMEDICO AG
- Brief Summary
Translation and validation of the BOMET-QoL-10 questionnaire in Germany and assessment of its validity and responsiveness.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 370
- 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
- Patients without bone metastases
- Participation in another study involving questionnaires
- Patients not able to comply with the assessments specified in the protocol
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method QoL 6 months Validity and responsiveness of the BOMET-QoL-10 questionnaire in reference to EORTC QLQ-C30/BM-22
- Secondary Outcome Measures
Name Time Method Impact of characteristics on questionnaire scores 6 months Impact of tumour entity, comorbidity and further parameters on the scores of bone metastasis at baseline
Sensitivity of questionnaire 6 months Sensitivity of BOMET-QoL-10 in patients with / without progression of the disease
Sequence effects of questionnaires 6 months Influence on the order questionnaires are filled out
Trial Locations
- Locations (1)
Multiple Sites All Over Germany
🇩🇪Multiple Locations, Germany