NCT02293642

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
370

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2014

Completed
13 days until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

August 10, 2018

Status Verified

August 1, 2018

Enrollment Period

1.5 years

First QC Date

November 14, 2014

Last Update Submit

August 8, 2018

Conditions

Bone Metastasis

Keywords

primary cancers of the breastprimary cancers of the kidneyprimary cancers of the lungprimary cancers of the prostate

Outcome Measures

Primary Outcomes (1)

  • QoL

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

    6 months

Secondary Outcomes (3)

  • Impact of characteristics on questionnaire scores

    6 months

  • Sensitivity of questionnaire

    6 months

  • Sequence effects of questionnaires

    6 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with bone metastases from primary cancers of the breast, kidney, lung or prostate

You may qualify if:

  • 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

You may not qualify if:

  • Patients without bone metastases
  • Participation in another study involving questionnaires
  • Patients not able to comply with the assessments specified in the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Multiple Sites All Over Germany

Multiple Locations, Germany

Location

Related Publications (1)

  • 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.

    PMID: 29874105RESULT

Study Officials

  • Norbert Marschner, MD

    Outpatient Centre for Interdisciplinary Oncology and Haematology, D-Freiburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2014

First Posted

November 18, 2014

Study Start

December 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

August 10, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)