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

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

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

Study Overview

• Status: Completed
• Conditions: Breast Carcinoma Metastatic to the Bone
• Intervention / Treatment: Diagnostic test: BOMET-QoL questionnaire

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.

• Study Type: Observational
• Enrollment (Actual): 241

Contacts and Locations

Study Locations

• Spain
  • Andalucia
    • Sevilla, Andalucia, Spain, 41013
      • Hospital Universitario Virgen del Rocio
  • Castilla-La Mancha
    • Guadalajara, Castilla-La Mancha, Spain, 19002
      • Hospital General de Guadalajara
  • Cataluña
    • Badalona, Cataluña, Spain, 08916
      • ICO Badalona Hospital Universitari Germans Trias I Pujol
    • Barcelona, Cataluña, Spain, 08036
      • Hospital Universitari Clinic I Provincial
    • Barcelona, Cataluña, Spain, 08041
      • Hospital Santa Creu i Sant Pau
    • Barcelona, Cataluña, Spain, 08221
      • Hospital Mútua de Terrassa
    • Gerona, Cataluña, Spain, 17007
      • ICO Girona Hospital Dr. Josep Trueta
    • Lleida, Cataluña, Spain, 25198
      • Hospital Universitari Arnau de Vilanova
    • Manresa, Cataluña, Spain, 08243
      • Fundació Althaia, Xarxa Assistencial de Manresa
  • Cominidad Valenciana
    • Alicante, Cominidad Valenciana, Spain, 03010
      • Hospital General Universitario de Alicante
  • Comunidad Valenciana
    • Valencia, Comunidad Valenciana, Spain, 46010
      • Hospital Clinico Universitario de Valencia
  • Galicia
    • A Coruña, Galicia, Spain, 15006
      • Complejo Hospitalario Universitario A Coruna
    • A Coruña, Galicia, Spain, 15009
      • Centro Oncologico de Galicia
    • Pontevedra, Galicia, Spain, 36164
      • Complejo Hospitalario de Pontevedra
  • Huesca
    • Barbastro, Huesca, Spain, 22300
      • Hospital de Barbastro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Spanish Breast Cancer Research Group
• Collaborators: Novartis Pharmaceuticals
• Investigators: Study Director: Study Director, Hospital Santa Creu i Sant Pau

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2007
• Primary Completion (Actual): May 20, 2010
• Study Completion (Actual): July 7, 2012

Study Registration Dates

• First Submitted: February 18, 2019
• First Submitted That Met QC Criteria: February 18, 2019
• First Posted (Actual): February 20, 2019

Study Record Updates

• Last Update Posted (Estimate): March 6, 2023
• Last Update Submitted That Met QC Criteria: March 3, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: treatment; quality of life; bone metastasis; metastatic breast cancer; psychometric; assessments
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Neoplastic Processes; Breast Neoplasms; Neoplasm Metastasis
• Other Study ID Numbers: Mabomet

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No