Breast Carcinoma Metastatic to the BoneMAbometNCT03847220
Study of the Utility of the BOMET-QOL Questionnaire Patients With Breast Cancer and Bone Metastasis
An observational study of Breast Carcinoma Metastatic to the Bone, run by Spanish Breast Cancer Research Group at 15 sites in Spain.
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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Carcinoma Metastatic to the Bone
- What is being tested?
- BOMET-QoL questionnaire
- How many people
- 241 participants
- Where
- 15 sitesSpain
- Study dates
- 23 Oct 2007to 7 Jul 2012
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Spain15 sites
Complejo Hospitalario Universitario A Coruña
A Coruña, Galicia, 15006
Centro Oncologico de Galicia
A Coruña, Galicia, 15009
Hospital General Universitario de Alicante
Alicante, Cominidad Valenciana, 03010
ICO Badalona Hospital Universitari Germans Trias I Pujol
Badalona, Catalonia, 08916
Hospital de Barbastro
Barbastro, Huesca, 22300
Hospital Universitari Clinic I Provincial
Barcelona, Catalonia, 08036
Hospital Santa Creu I Sant Pau
Barcelona, Catalonia, 08041
Hospital Mutua de Terrassa
Barcelona, Catalonia, 08221
ICO Girona Hospital Dr. Josep Trueta
Girona, Catalonia, 17007
Hospital General de Guadalajara
Guadalajara, Castille-La Mancha, 19002
Hospital Universitari Arnau de Vilanova
Lleida, Catalonia, 25198
Fundació Althaia, Xarxa Assistencial de Manresa
Manresa, Catalonia, 08243
Complejo Hospitalario de Pontevedra
Pontevedra, Galicia, 36164
Hospital Universitario Virgen Del Rocío
Seville, Andalusia, 41013
Hospital Clínico Universitario de Valencia
Valencia, Valencia, 46010
About this study
Official title: 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).
Read the 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.
- Conditions
- Breast Carcinoma Metastatic to the Bone
- Being tested
- BOMET-QoL questionnaire
- Keywords
- metastatic breast cancer, bone metastasis, quality of life, psychometric, treatment, assessments
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BOMET-QoL questionnaireDiagnostic test
study to evaluate the utility of the BOMET-QoL questionnaire in patients with BC and BM
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 24 months
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start23 Oct 2007
- Primary completion20 May 2010
- Study completion7 Jul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Carcinoma Metastatic to the BoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 241 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Spanish Breast Cancer Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03847220
- Sponsor's protocol ID
- Mabomet
- Acronym
- MAbomet
- Status last verified
- Mar 2023
- First submitted
- 18 Feb 2019
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 31865481
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of the Utility of the BOMET-QOL Questionnaire Patients With Breast Cancer and Bone Metastasis
- ClinicalTrials.gov ID
- NCT03847220
- Acronym / sponsor ID
- MAbomet / Mabomet
- Conditions
- Breast Carcinoma Metastatic to the Bone
- Keywords
- metastatic breast cancer, bone metastasis, quality of life, psychometric, treatment, assessments
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Spanish Breast Cancer Research GroupUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- 23 Oct 2007 (actual)
- Primary completion
- 20 May 2010 (actual)
- Study completion
- 7 Jul 2012 (actual)
- First posted
- 20 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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 is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BOMET-QoL questionnairestudy to evaluate the utility of the BOMET-QoL questionnaire in patients with BC and BM | Diagnostic test | – |
Primary outcome
Impact on the HRQoL
Time frame: Up to 24 months
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.
6 secondary outcomes
Measurement properties of the BOMET-QoL questionnaire: validity
Time frame: Up to 24 months
Measurement properties of the BOMET-QoL questionnaire: feasibility
Time frame: Up to 24 months
Measurement properties of the BOMET-QoL questionnaire: sensitivity to change
Time frame: Up to 24 months
Impact of skeletal-related events (SREs) on HRQoL (BOMET-QoL scores)
Time frame: Up to 24 months
Relation between Eastern Cooperative Oncology Group (ECOG) and HRQoL (BOMET-QoL scores).
Time frame: Up to 24 months
Correlation between visual analogue scale (VAS) score of pain and HRQoL (BOMET-QoL scores).
Time frame: Up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Results publication: PubMed 31865481Barnadas 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.
- Spanish Breast Cancer Research Group (GEICAM) is a Spanish Breast Cancer Research GroupLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Carcinoma Metastatic to the Bone, run by Spanish Breast Cancer Research Group at 15 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact on the HRQoL (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03847220, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2023.