Bone Metastasis
Conditions
Keywords
primary cancers of the breast, primary cancers of the kidney, primary cancers of the lung, primary cancers of the prostate
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.
Interventions
None listed
Sponsors
iOMEDICO AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| QoL | 6 months | Validity and responsiveness of the BOMET-QoL-10 questionnaire in reference to EORTC QLQ-C30/BM-22 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sequence effects of questionnaires | 6 months | Influence on the order questionnaires are filled out |
| Sensitivity of questionnaire | 6 months | Sensitivity of BOMET-QoL-10 in patients with / without progression of the disease |
| Impact of characteristics on questionnaire scores | 6 months | Impact of tumour entity, comorbidity and further parameters on the scores of bone metastasis at baseline |
Countries
Germany
Outcome results
None listed