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Completed

NCT Number: NCT02293642

Bone Pain Score Validation Initiative

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

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Key information

Conditions

Bone Metastasis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Sites All Over Germany

Multiple Locations, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. QoL

    Time frame: 6 months

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

Secondary outcomes

  1. Impact of characteristics on questionnaire scores

    Time frame: 6 months

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

  2. Sensitivity of questionnaire

    Time frame: 6 months

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

  3. Sequence effects of questionnaires

    Time frame: 6 months

    Influence on the order questionnaires are filled out

Sponsors and collaborators

Lead sponsor

iOMEDICO AG

Industry

Registry information

Official study title

Prospective Epidemiology Study to Validate the BOMET-QoL-10 in Patients With Bone Metastasis in Germany

Acronym: ARIE

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 18, 2014
Registry last updated
Aug 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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