Clinical trial · Observational
Study of the Utility of the BOMET-QOL Questionnaire Patients With Breast Cancer and Bone Metastasis
Prospective Study of the Utility of the BOMET-QOL Questionnaire Patients With Breast Cancer and Bone Metastasis
NCT03847220CI-TRIAL-00064490MAbometcompletedClinicalTrials.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)
Epidemiological, prospective and multicenter study to evaluate the utility of the BOMET-QoL questionnaire in patients with breast cancer (BC) and bone metastases (BM).
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 |
|---|---|---|---|
| Breast Carcinoma Metastatic to the Bone | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BOMET-QoL questionnaire | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Impact on the HRQoL
- timeFrame
- Up to 24 months
- description
- Impact on the HRQoL of patients with BC and BM will be measured by the BOMET-QoL questionnaire in the context of normal clinical practice. The questionnaire will be administered to patients in each study visit from baseline visit to the final visit at 24 months. The score of the questionnaire will be measured as: Score: 0 - Always, 1 - Nearly always, 2 - Sometimes, 3 - Rarely, 4 - Never, were never is the best option and always means patient has a bad health condition.
Secondary outcomes (6)
- measure
- Measurement properties of the BOMET-QoL questionnaire: validity
- timeFrame
- Up to 24 months
- description
- Its cross-sectional validity will be evaluated by analysing the relationship between the BOMET-QoL scores and different clinical variables (presence of Skeleton-Related Event (SREs), symptoms and Eastern Cooperative Oncology Group (ECOG) index). The relationship between the pain VAS score and the question about state of health perceived by patient with HRQoL according to BOMET-QoL will be analysed.
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient over 18 years of age. * Patient diagnosed with BC and BM. * Patient who has granted informed consent in writing to participate in the study. * Patient capable of understanding and completing the questionnaires Exclusion Criteria: * Patient with another type of disease that, in the investigator's opinion, could mask the study results. * Patients with a life expectancy of less than 8 months. * Patient who is participating in a clinical trial with an unregistered drug at the start of the study.
References
Publications (1)
- RESULTBarnadas A, Munoz M, Margeli M, Chacon JI, Cassinello J, Antolin S, Adrover E, Ramos M, Carrasco E, Jimeno MA, Ojeda B, Gonzalez X, Gonzalez S, Constenla M, Florian J, Miguel A, Llombart A, Lluch A, Ruiz-Borrego M, Colomer R, Del Barco S; GEICAM, Spanish Breast Cancer Group. BOMET-QoL-10 questionnaire for breast cancer patients with bone metastasis: the prospective MABOMET GEICAM study. J Patient Rep Outcomes. 2019 Dec 21;3(1):72. doi: 10.1186/s41687-019-0161-y. PMID 31865481