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

Breast Carcinoma Metastatic to the Bone Clinical Trial

— MAbomet  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03847220
• Other study ID #: Mabomet
• Status: Completed
• Start date: October 23, 2007
• Est. completion date: July 7, 2012

Study information

• Verified date: March 2023
• Source: Spanish Breast Cancer Research Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: July 7, 2012
• Est. primary completion date: May 20, 2010
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Carcinoma Metastatic to the Bone
• Breast Neoplasms
• Neoplasm Metastasis

Intervention

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

Locations

Country	Name	City	State
Spain	Centro Oncologico de Galicia	A Coruña	Galicia
Spain	Complejo Hospitalario Universitario A Coruña	A Coruña	Galicia
Spain	Hospital General Universitario de Alicante	Alicante	Cominidad Valenciana
Spain	ICO Badalona Hospital Universitari Germans Trias I Pujol	Badalona	Cataluña
Spain	Hospital de Barbastro	Barbastro	Huesca
Spain	Hospital Mutua de Terrassa	Barcelona	Cataluña
Spain	Hospital Santa Creu I Sant Pau	Barcelona	Cataluña
Spain	Hospital Universitari Clinic I Provincial	Barcelona	Cataluña
Spain	ICO Girona Hospital Dr. Josep Trueta	Gerona	Cataluña
Spain	Hospital General de Guadalajara	Guadalajara	Castilla-La Mancha
Spain	Hospital Universitari Arnau de Vilanova	Lleida	Cataluña
Spain	Fundació Althaia, Xarxa Assistencial de Manresa	Manresa	Cataluña
Spain	Complejo Hospitalario de Pontevedra	Pontevedra	Galicia
Spain	Hospital Universitario Virgen Del Rocío	Sevilla	Andalucia
Spain	Hospital Clínico Universitario de Valencia	Valencia	Comunidad Valenciana

Sponsors (2)

Lead Sponsor	Collaborator
Spanish Breast Cancer Research Group	Novartis Pharmaceuticals

Country where clinical trial is conducted

Spain, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Measurement properties of the BOMET-QoL questionnaire: validity	Its cross-sectional validity will be evaluated by analysing the relationship between the BOMET-QoL scores and different clinical variables (presence of Skeleton-Related Event (SREs), symptoms and Eastern Cooperative Oncology Group (ECOG) index). The relationship between the pain VAS score and the question about state of health perceived by patient with HRQoL according to BOMET-QoL will be analysed.	Up to 24 months
Secondary	Measurement properties of the BOMET-QoL questionnaire: feasibility	BOMET-QoL will be considered rapidly completed if patients complete questionnaire in less than 10 minutes.	Up to 24 months
Secondary	Measurement properties of the BOMET-QoL questionnaire: sensitivity to change	Sensitivity to change can be evaluated by calculating the effect size or the Minimum Clinically Important Difference, as statistics based on effect size provide direct information about the magnitude of the change, expressed as a variation, also used to calculate the Minimum Clinically Important Difference.	Up to 24 months
Secondary	Impact of skeletal-related events (SREs) on HRQoL (BOMET-QoL scores)	The impact of skeletal-related events (SREs) on HRQoL (BOMET-QoL scores) will be measured by comparing patients who presented SREs with patients with without SREs.	Up to 24 months
Secondary	Relation between Eastern Cooperative Oncology Group (ECOG) and HRQoL (BOMET-QoL scores).	ECOG: This scale consists of 5 levels (0 = No restrictions to carry out the activities normal, 1 = Restrictions to perform vigorous physical activities. It has the capacity to perform ambulation and light work, 2 = Ability to ambulate and perform personal care but not able to work. Capacity for standing and walking for> 50% of waking hours, 3 = Able to perform care limited personal; Incarcerated or restrained to be in a chair for> 50% of the hours of vigil, 4 = complete disability; he can not perform any personal care; it remains in bed or in a chair all the time, 5 = Death). In it the observer assesses the state of symptoms and the level of functioning in relation to ambulatory status and need for care. Patients with an Eastern Cooperative Oncology Group (ECOG) functional scale between 0-1 will obtain a higher score (better HRQoL) in the BOMET-QoL questionnaire.	Up to 24 months
Secondary	Correlation between visual analogue scale (VAS) score of pain and HRQoL (BOMET-QoL scores).	At the baseline visit, patients who obtain higher scores on the Analogue Visual Pain Scale will obtain a lower score (worse HRQOL) in the BOMET-QoL questionnaire. Correlation between the BOMET-QoL scores and the pain VAS scores regarding whether it improves, stays the same or gets worse between the different study visits. VAS: 0 no pain - 10 unbearable pain	Up to 24 months

External Links

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