Bone MetastasisARIENCT02293642
Bone Pain Score Validation Initiative
An observational study of Bone Metastasis, run by iOMEDICO AG at 1 site in Germany.
Trial summary
Translation and validation of the BOMET-QoL-10 questionnaire in Germany and assessment of its validity and responsiveness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Metastasis
- How many people
- 370 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2014to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with bone metastases from primary cancers of the breast, kidney, lung or prostate
Who may be able to join
- 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
Who cannot join
- Patients without bone metastases
- Participation in another study involving questionnaires
- Patients not able to comply with the assessments specified in the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Epidemiology Study to Validate the BOMET-QoL-10 in Patients With Bone Metastasis in Germany
Translation and validation of the BOMET-QoL-10 questionnaire in Germany and assessment of its validity and responsiveness.
Read the 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.
- Conditions
- Bone Metastasis
- Keywords
- primary cancers of the breast, primary cancers of the kidney, primary cancers of the lung, primary cancers of the prostate
What is being measured
The primary outcome is the main question the study is designed to answer.
QoL
Validity and responsiveness of the BOMET-QoL-10 questionnaire in reference to EORTC QLQ-C30/BM-22
Measured: 6 months
Secondary outcomes (3)
Impact of characteristics on questionnaire scores
Impact of tumour entity, comorbidity and further parameters on the scores of bone metastasis at baseline
Measured: 6 months
Sensitivity of questionnaire
Sensitivity of BOMET-QoL-10 in patients with / without progression of the disease
Measured: 6 months
Sequence effects of questionnaires
Influence on the order questionnaires are filled out
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone MetastasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 370 participants (actual)
Sponsor and investigators
- Lead sponsor
- iOMEDICO AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Norbert Marschner, MD, Principal investigator, Outpatient Centre for Interdisciplinary Oncology and Haematology, D-Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02293642
- Sponsor's protocol ID
- IOM-268
- Acronym
- ARIE
- Status last verified
- Aug 2018
- First submitted
- 14 Nov 2014
- Last updated
- 10 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Marschner 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.
PubMed 29874105
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Epidemiology Study to Validate the BOMET-QoL-10 in Patients With Bone Metastasis in Germany
- ClinicalTrials.gov ID
- NCT02293642
- Acronym / sponsor ID
- ARIE / IOM-268
- Conditions
- Bone Metastasis
- Keywords
- primary cancers of the breast, primary cancers of the kidney, primary cancers of the lung, primary cancers of the prostate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 370 participants (actual)
- Lead sponsor
- iOMEDICO AGIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 18 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with bone metastases from primary cancers of the breast, kidney, lung or prostate
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Patients without bone metastases
- Participation in another study involving questionnaires
- Patients not able to comply with the assessments specified in the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
QoL
Time frame: 6 months
Validity and responsiveness of the BOMET-QoL-10 questionnaire in reference to EORTC QLQ-C30/BM-22
3 secondary outcomes
Impact of characteristics on questionnaire scores
Time frame: 6 months
Sensitivity of questionnaire
Time frame: 6 months
Sequence effects of questionnaires
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2018.
- Results publication: PubMed 29874105Marschner 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norbert Marschner, MD principal investigator
Outpatient Centre for Interdisciplinary Oncology and Haematology, D-Freiburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Metastasis, run by iOMEDICO AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QoL (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02293642, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2018.