Study of the Utility of the BOMET-QOL Questionnaire Patients With Breast Cancer and Bone Metastasis

NCT ID: NCT03847220

Last Updated: 2023-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

241 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-10-23

Study Completion Date

2012-07-07

Brief Summary

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Epidemiological, prospective and multicenter study to evaluate the utility of the BOMET-QoL questionnaire in patients with breast cancer (BC) and bone metastases (BM).

Detailed Description

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Population: Patients over 18 with breast cancer and bone metastasis.

Inclusion criteria:

* Patient over 18 years of age.
* Patient diagnosed with breast cancer (BC) and bone metastases (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.

Conditions

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Breast Carcinoma Metastatic to the Bone

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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BOMET-QoL questionnaire

study to evaluate the utility of the BOMET-QoL questionnaire in patients with BC and BM

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Spanish Breast Cancer Research Group

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Locations

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Hospital Universitario Virgen Del Rocío

Seville, Andalusia, Spain

Site Status

Hospital General de Guadalajara

Guadalajara, Castille-La Mancha, Spain

Site Status

ICO Badalona Hospital Universitari Germans Trias I Pujol

Badalona, Catalonia, Spain

Site Status

Hospital Universitari Clinic I Provincial

Barcelona, Catalonia, Spain

Site Status

Hospital Santa Creu I Sant Pau

Barcelona, Catalonia, Spain

Site Status

Hospital Mutua de Terrassa

Barcelona, Catalonia, Spain

Site Status

ICO Girona Hospital Dr. Josep Trueta

Girona, Catalonia, Spain

Site Status

Hospital Universitari Arnau de Vilanova

Lleida, Catalonia, Spain

Site Status

Fundació Althaia, Xarxa Assistencial de Manresa

Manresa, Catalonia, Spain

Site Status

Hospital General Universitario de Alicante

Alicante, Cominidad Valenciana, Spain

Site Status

Complejo Hospitalario Universitario A Coruña

A Coruña, Galicia, Spain

Site Status

Centro Oncologico de Galicia

A Coruña, Galicia, Spain

Site Status

Complejo Hospitalario de Pontevedra

Pontevedra, Galicia, Spain

Site Status

Hospital de Barbastro

Barbastro, Huesca, Spain

Site Status

Hospital Clínico Universitario de Valencia

Valencia, Valencia, Spain

Site Status

Countries

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Spain

References

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Barnadas 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.

Reference Type RESULT
PMID: 31865481 (View on PubMed)

Related Links

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http://www.geicam.org

Spanish Breast Cancer Research Group (GEICAM) is a Spanish Breast Cancer Research Group

Other Identifiers

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Mabomet

Identifier Type: -

Identifier Source: org_study_id

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