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

NCT03847220 | Completed

• 1 other identifier: Mabomet
• Study Type: observational
• Target: 241
• Locations: 1 country
• Sites: 15

Brief Summary

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

Conditions

Breast Carcinoma Metastatic to the Bone

Keywords

metastatic breast cancer; bone metastasis; quality of life; psychometric; treatment; assessments

Outcome Measures

Primary Outcomes (1)

• Impact on the HRQoL

  Impact on the HRQoL of patients with BC and BM will be measured by the BOMET-QoL questionnaire in the context of normal clinical practice. The questionnaire will be administered to patients in each study visit from baseline visit to the final visit at 24 months. The score of the questionnaire will be measured as: Score: 0 - Always, 1 - Nearly always, 2 - Sometimes, 3 - Rarely, 4 - Never, were never is the best option and always means patient has a bad health condition.

  Up to 24 months

Secondary Outcomes (6)

• Measurement properties of the BOMET-QoL questionnaire: validity

  Up to 24 months

• Measurement properties of the BOMET-QoL questionnaire: feasibility

  Up to 24 months

• Measurement properties of the BOMET-QoL questionnaire: sensitivity to change

  Up to 24 months

• Impact of skeletal-related events (SREs) on HRQoL (BOMET-QoL scores)

  Up to 24 months

• Relation between Eastern Cooperative Oncology Group (ECOG) and HRQoL (BOMET-QoL scores).

  Up to 24 months

Interventions

BOMET-QoL questionnaire DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: female patient over 18 years of age
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients susceptible for inclusion in the study were women with breast cancer and bone metastasis in any location who met the screening criteria described in the study protoco

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Spanish Breast Cancer Research Group: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (15)

Hospital Universitario Virgen Del Rocío

Seville, Andalusia, 41013, Spain

Location

Hospital General de Guadalajara

Guadalajara, Castille-La Mancha, 19002, Spain

Location

ICO Badalona Hospital Universitari Germans Trias I Pujol

Badalona, Catalonia, 08916, Spain

Location

Hospital Universitari Clinic I Provincial

Barcelona, Catalonia, 08036, Spain

Location

Hospital Santa Creu I Sant Pau

Barcelona, Catalonia, 08041, Spain

Location

Hospital Mutua de Terrassa

Barcelona, Catalonia, 08221, Spain

Location

ICO Girona Hospital Dr. Josep Trueta

Girona, Catalonia, 17007, Spain

Location

Hospital Universitari Arnau de Vilanova

Lleida, Catalonia, 25198, Spain

Location

Fundació Althaia, Xarxa Assistencial de Manresa

Manresa, Catalonia, 08243, Spain

Location

Hospital General Universitario de Alicante

Alicante, Cominidad Valenciana, 03010, Spain

Location

Complejo Hospitalario Universitario A Coruña

A Coruña, Galicia, 15006, Spain

Location

Centro Oncologico de Galicia

A Coruña, Galicia, 15009, Spain

Location

Complejo Hospitalario de Pontevedra

Pontevedra, Galicia, 36164, Spain

Location

Hospital de Barbastro

Barbastro, Huesca, 22300, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, Valencia, 46010, Spain

Location

Related Publications (1)

• 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.

  PMID: 31865481 RESULT

Related Links

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

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Study Director

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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2019
• First Posted: February 20, 2019
• Study Start: October 23, 2007
• Primary Completion: May 20, 2010
• Study Completion: July 7, 2012
• Last Updated: March 6, 2023

Record last verified: 2023-03

Locations

ES (15)