Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT03847220
Status:
COMPLETED
Last Update Posted:
2023-03-06
First Post:
2019-02-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of the Utility of the BOMET-QOL Questionnaire Patients With Breast Cancer and Bone Metastasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 241}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2012-07-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-03', 'studyFirstSubmitDate': '2019-02-18', 'studyFirstSubmitQcDate': '2019-02-18', 'lastUpdatePostDateStruct': {'date': '2023-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-05-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impact on the HRQoL', 'timeFrame': 'Up to 24 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Measurement properties of the BOMET-QoL questionnaire: validity', 'timeFrame': 'Up to 24 months', 'description': '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.'}, {'measure': 'Measurement properties of the BOMET-QoL questionnaire: feasibility', 'timeFrame': 'Up to 24 months', 'description': 'BOMET-QoL will be considered rapidly completed if patients complete questionnaire in less than 10 minutes.'}, {'measure': 'Measurement properties of the BOMET-QoL questionnaire: sensitivity to change', 'timeFrame': 'Up to 24 months', 'description': '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.'}, {'measure': 'Impact of skeletal-related events (SREs) on HRQoL (BOMET-QoL scores)', 'timeFrame': 'Up to 24 months', 'description': '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.'}, {'measure': 'Relation between Eastern Cooperative Oncology Group (ECOG) and HRQoL (BOMET-QoL scores).', 'timeFrame': 'Up to 24 months', 'description': '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.'}, {'measure': 'Correlation between visual analogue scale (VAS) score of pain and HRQoL (BOMET-QoL scores).', 'timeFrame': 'Up to 24 months', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['metastatic breast cancer', 'bone metastasis', 'quality of life', 'psychometric', 'treatment', 'assessments'], 'conditions': ['Breast Carcinoma Metastatic to the Bone']}, 'referencesModule': {'references': [{'pmid': '31865481', 'type': 'RESULT', '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.'}], 'seeAlsoLinks': [{'url': 'http://www.geicam.org', 'label': 'Spanish Breast Cancer Research Group (GEICAM) is a Spanish Breast Cancer Research Group'}]}, 'descriptionModule': {'briefSummary': 'Epidemiological, prospective and multicenter study to evaluate the utility of the BOMET-QoL questionnaire in patients with breast cancer (BC) and bone metastases (BM).', 'detailedDescription': "Population: Patients over 18 with breast cancer and bone metastasis.\n\nInclusion criteria:\n\n* Patient over 18 years of age.\n* Patient diagnosed with breast cancer (BC) and bone metastases (BM).\n* Patient who has granted informed consent in writing to participate in the study.\n* Patient capable of understanding and completing the questionnaires.\n\nExclusion criteria:\n\n* Patient with another type of disease that, in the investigator's opinion, could mask the study results.\n* Patients with a life expectancy of less than 8 months.\n* Patient who is participating in a clinical trial with an unregistered drug at the start of the study."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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', 'genderDescription': 'female patient over 18 years of age', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient over 18 years of age.\n* Patient diagnosed with BC and BM.\n* Patient who has granted informed consent in writing to participate in the study.\n* Patient capable of understanding and completing the questionnaires\n\nExclusion Criteria:\n\n* Patient with another type of disease that, in the investigator's opinion, could mask the study results.\n* Patients with a life expectancy of less than 8 months.\n* Patient who is participating in a clinical trial with an unregistered drug at the start of the study."}, 'identificationModule': {'nctId': 'NCT03847220', 'acronym': 'MAbomet', 'briefTitle': 'Study of the Utility of the BOMET-QOL Questionnaire Patients With Breast Cancer and Bone Metastasis', 'organization': {'class': 'OTHER', 'fullName': 'Spanish Breast Cancer Research Group'}, 'officialTitle': 'Prospective Study of the Utility of the BOMET-QOL Questionnaire Patients With Breast Cancer and Bone Metastasis', 'orgStudyIdInfo': {'id': 'Mabomet'}}, 'armsInterventionsModule': {'interventions': [{'name': 'BOMET-QoL questionnaire', 'type': 'DIAGNOSTIC_TEST', 'description': 'study to evaluate the utility of the BOMET-QoL questionnaire in patients with BC and BM'}]}, 'contactsLocationsModule': {'locations': [{'zip': '41013', 'city': 'Seville', 'state': 'Andalusia', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen Del Rocío', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '19002', 'city': 'Guadalajara', 'state': 'Castille-La Mancha', 'country': 'Spain', 'facility': 'Hospital General de Guadalajara', 'geoPoint': {'lat': 40.62862, 'lon': -3.16185}}, {'zip': '08916', 'city': 'Badalona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'ICO Badalona Hospital Universitari Germans Trias I Pujol', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'zip': '08036', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Hospital Universitari Clinic I Provincial', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08041', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Hospital Santa Creu I Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08221', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Hospital Mutua de Terrassa', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '17007', 'city': 'Girona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'ICO Girona Hospital Dr. Josep Trueta', 'geoPoint': {'lat': 41.98311, 'lon': 2.82493}}, {'zip': '25198', 'city': 'Lleida', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Hospital Universitari Arnau de Vilanova', 'geoPoint': {'lat': 41.61674, 'lon': 0.62218}}, {'zip': '08243', 'city': 'Manresa', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Fundació Althaia, Xarxa Assistencial de Manresa', 'geoPoint': {'lat': 41.72815, 'lon': 1.82399}}, {'zip': '03010', 'city': 'Alicante', 'state': 'Cominidad Valenciana', 'country': 'Spain', 'facility': 'Hospital General Universitario de Alicante', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'zip': '15006', 'city': 'A Coruña', 'state': 'Galicia', 'country': 'Spain', 'facility': 'Complejo Hospitalario Universitario A Coruña', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'zip': '15009', 'city': 'A Coruña', 'state': 'Galicia', 'country': 'Spain', 'facility': 'Centro Oncologico de Galicia', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'zip': '36164', 'city': 'Pontevedra', 'state': 'Galicia', 'country': 'Spain', 'facility': 'Complejo Hospitalario de Pontevedra', 'geoPoint': {'lat': 42.431, 'lon': -8.64435}}, {'zip': '22300', 'city': 'Barbastro', 'state': 'Huesca', 'country': 'Spain', 'facility': 'Hospital de Barbastro', 'geoPoint': {'lat': 42.03565, 'lon': 0.12686}}, {'zip': '46010', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spanish Breast Cancer Research Group', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}