Bone Pain Score Validation Initiative

iOMEDICO AG370 enrolled

Overview

Translation and validation of the BOMET-QoL-10 questionnaire in Germany and assessment of its validity and responsiveness.

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.

Study Type

OBSERVATIONAL

Enrollment

370

Conditions

Bone Metastasis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Multiple Sites All Over Germany

Multiple Locations, Germany

Outcomes

Primary Outcomes

QoL

Validity and responsiveness of the BOMET-QoL-10 questionnaire in reference to EORTC QLQ-C30/BM-22

Time frame: 6 months

Secondary Outcomes

Impact of characteristics on questionnaire scores

Impact of tumour entity, comorbidity and further parameters on the scores of bone metastasis at baseline

Time frame: 6 months

Sensitivity of questionnaire

Sensitivity of BOMET-QoL-10 in patients with / without progression of the disease

Time frame: 6 months

Sequence effects of questionnaires

Influence on the order questionnaires are filled out

Time frame: 6 months

Data from ClinicalTrials.gov

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