Quality of Life in Metastatic Breast Cancer (MBC) Patients in Second Line Monochemotherapy
NCT ID: NCT02403869
Last Updated: 2022-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
149 participants
OBSERVATIONAL
2014-03-12
2019-01-31
Brief Summary
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Detailed Description
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A total of 200 patients are expected to be recruited from 32 Spanish sites.
In this study the results perceived by patients will be compiled to assess overall Quality of Life (QoL) in MBC patients treated with second-line monochemotherapy, using the EORTC QLQ-C30 questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire) and its modules EORTC QLQ-BR23 (EORTC Breast Cancer specific) and EORTC QLQ-CIPN20 (EORTC Chemotherapy-Induced Peripheral Neuropathy).
Patients will be evaluated at the time of acceptance to participate in the study after signing the informed consent and will be tracked every three months during treatment with second-line monochemotherapy, coinciding with routine assessments within normal clinical practice. When the patient completes treatment with second-line chemotherapy he/she will enter the post-treatment period, with follow-up at six and 12 months after completion of treatment. Also, patients will be followed to assess survival until the end of the study (30 months after enrolment of the last patient in the study). Follow-up time has been established based on the median survival of patients with MBC
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group 1
MBC patients starting treatment with monochemotherapy for second line of quimiotherapy treatment for metastatic disease
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Patients with metastatic breast cancer who start treatment with second-line monochemotherapy.
* Patients of both sexes, at least 18 years of age and of any race.
* Patients with life expectancy longer than or equal to 12 weeks.
* Patients with histological or cytological diagnosis of Her-2/neu negative breast adenocarcinoma.
* Patients with ability enough to understand the questionnaires.
Exclusion Criteria
* Patients who have been treated with chemotherapy in the last three weeks
* Patients who refuse to participate in the study.
18 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Hospital Juan Ramón Jiménez
Huelva, Andalusia, Spain
Hospital Virgen de Valme
Seville, Andalusia, Spain
Hospital Virgen del Rocío
Seville, Andalusia, Spain
Hospital Miguel Servet
Zaragoza, Aragon, Spain
Hospital Universitario Lozano Blesa
Zaragoza, Aragon, Spain
Hospital Son Llatzer
Palma de Mallorca, Balearic Islands, Spain
Hospital Universitario Son Espases
Palma Mallorca, Balearic Islands, Spain
Hospital Universitario Canarias
La Laguna, Santa Cruz de Tenerife, Canary Islands, Spain
Hospital Universitario Burgos
Burgos, Castille and León, Spain
Complejo Hospitalario de León
León, Castille and León, Spain
Hospital Bierzo
León, Castille and León, Spain
Hospital Universitario Salamanca
Salamanca, Castille and León, Spain
Hospital Virgen de la Salud. Toledo
Toledo, Castille-La Mancha, Spain
Centro Médico Teknon
Barcelona, Catalonia, Spain
Hospital Clinic Barcelona
Barcelona, Catalonia, Spain
Hospital Universitario San Joan de Reus
Reus, Tarragona, Catalonia, Spain
Corporación Sanitaria Parc Taulí- Sabadell
Sabadell, Catalonia, Spain
H. Infanta Cristina de Badajoz
Badajoz, Extremadura, Spain
H. San Pedro de Alcántara
Cáceres, Extremadura, Spain
Complejo Hospitalario de Ourense
Ourense, Galicia, Spain
Complejo Hospitalario de Pontevedra-Montecelo
Pontevedra, Galicia, Spain
Complejo Hospitalario Universitario de Santiago Compostela
Santiago de Compostela, Galicia, Spain
Complejo Hospitalario de Vigo
Vigo, Galicia, Spain
Hospital Universitario de Navarra
Pamplona, Navarre, Spain
Hospital Universitario Elche
Elche, Valencia, Spain
Hospital Universitario y Politécnico La Fe
Valencia, Valencia, Spain
Hospital Universitario Gregorio Marañón
Madrid, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Hospital Infanta Sofía
Madrid, , Spain
Countries
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Other Identifiers
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CEL-CMM-2013-01
Identifier Type: -
Identifier Source: org_study_id
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