Clinical trial NCT03847220: Study of the Utility of the BOMET-QOL Questionnaire Patients With Breast Cancer and Bone Metastasis
Official title: Prospective Study of the Utility of the BOMET-QOL Questionnaire Patients With Breast Cancer and Bone Metastasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Carcinoma Metastatic to the Bone
Keywords: metastatic breast cancer
bone metastasis
quality of life
psychometric
treatment
assessments
Lead sponsor: Spanish Breast Cancer Research Group
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2019-02-20
Enrollment: 241
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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).

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Impact on the HRQoL
timeFrame: Up to 24 months
Secondary outcomes:
measure: Measurement properties of the BOMET-QoL questionnaire: validity
timeFrame: Up to 24 months
measure: Measurement properties of the BOMET-QoL questionnaire: feasibility
timeFrame: Up to 24 months
measure: Measurement properties of the BOMET-QoL questionnaire: sensitivity to change
timeFrame: Up to 24 months
measure: Impact of skeletal-related events (SREs) on HRQoL (BOMET-QoL scores)
timeFrame: Up to 24 months
measure: Relation between Eastern Cooperative Oncology Group (ECOG) and HRQoL (BOMET-QoL scores).
timeFrame: Up to 24 months
measure: Correlation between visual analogue scale (VAS) score of pain and HRQoL (BOMET-QoL scores).
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Del Rocío
state: Andalucia
city: Guadalajara
country: Spain
facility: Hospital General de Guadalajara
state: Castilla-La Mancha
city: Badalona
country: Spain
facility: ICO Badalona Hospital Universitari Germans Trias I Pujol
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital Universitari Clinic I Provincial
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital Santa Creu I Sant Pau
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital Mutua de Terrassa
state: Cataluña
city: Gerona
country: Spain
facility: ICO Girona Hospital Dr. Josep Trueta
state: Cataluña
city: Lleida
country: Spain
facility: Hospital Universitari Arnau de Vilanova
state: Cataluña
city: Manresa
country: Spain
facility: Fundació Althaia, Xarxa Assistencial de Manresa
state: Cataluña
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
state: Cominidad Valenciana
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
state: Comunidad Valenciana
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña
state: Galicia
city: A Coruña
country: Spain
facility: Centro Oncologico de Galicia
state: Galicia
city: Pontevedra
country: Spain
facility: Complejo Hospitalario de Pontevedra
state: Galicia
city: Barbastro
country: Spain
facility: Hospital de Barbastro
state: Huesca
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Study Director
role: STUDY_DIRECTOR
References:
citation: 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.