Clinical trial · Observational
Bone Pain Score Validation Initiative
Prospective Epidemiology Study to Validate the BOMET-QoL-10 in Patients With Bone Metastasis in Germany
NCT02293642CI-TRIAL-00034275ARIEcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Translation and validation of the BOMET-QoL-10 questionnaire in Germany and assessment of its validity and responsiveness.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- QoL
- timeFrame
- 6 months
- description
- Validity and responsiveness of the BOMET-QoL-10 questionnaire in reference to EORTC QLQ-C30/BM-22
Secondary outcomes (3)
- measure
- Impact of characteristics on questionnaire scores
- timeFrame
- 6 months
- description
- Impact of tumour entity, comorbidity and further parameters on the scores of bone metastasis at baseline
- measure
- Sensitivity of questionnaire
- timeFrame
- 6 months
- description
- Sensitivity of BOMET-QoL-10 in patients with / without progression of the disease
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTMarschner 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). J Med Econ. 2018 Sep;21(9):920-929. doi: 10.1080/13696998.2018.1484750. Epub 2018 Jun 18. PMID 29874105