Spots Global Cancer Trial Database for Quality of Life in Metastatic Breast Cancer (MBC) Patients in Second Line Monochemotherapy
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Trial Identification
Brief Title: Quality of Life in Metastatic Breast Cancer (MBC) Patients in Second Line Monochemotherapy
Official Title: Study of Quality of Life in Patients With Metastatic Breast Cancer Treated With Second-line Monochemotherapy
Study ID: NCT02403869
Conditions
Interventions
Study Description
Brief Summary: Post-authorization, prospective follow-up, multi-centre, national study to estimate definitive deterioration in the quality of life in patients with metastatic breast cancer treated with second-line monochemotherapy.
Detailed Description: Post-authorization, prospective, multi-centre study in Metastatic Breast Cancer patients treated with second-line monochemotherapy. 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
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Hospital Juan Ramón Jiménez, Huelva, Andalucía, Spain
Hospital Virgen de Valme, Sevilla, Andalucía, Spain
Hospital Virgen del Rocío, Sevilla, Andalucía, Spain
Hospital Miguel Servet, Zaragoza, Aragón, Spain
Hospital Universitario Lozano Blesa, Zaragoza, Aragón, Spain
Hospital Son Llatzer, Palma de Mallorca, Baleares, Spain
Hospital Universitario Son Espases, Palma Mallorca, Baleares, Spain
Hospital Universitario Canarias, La Laguna, Santa Cruz De Tenerife, Canarias, Spain
Hospital Virgen de la Salud. Toledo, Toledo, Castilla La Mancha, Spain
Hospital Universitario Burgos, Burgos, Castilla Y León, Spain
Complejo Hospitalario de León, León, Castilla Y León, Spain
Hospital Bierzo, León, Castilla Y León, Spain
Hospital Universitario Salamanca, Salamanca, Castilla Y León, Spain
Centro Médico Teknon, Barcelona, Cataluña, Spain
Hospital Clinic Barcelona, Barcelona, Cataluña, Spain
Hospital Universitario San Joan de Reus, Reus, Tarragona, Cataluña, Spain
Corporación Sanitaria Parc Taulí- Sabadell, Sabadell, Cataluña, Spain
Hospital Universitario Elche, Elche, Comunidad Valenciana, Spain
Hospital Universitario y Politécnico La Fe, Valencia, Comunidad Valenciana, 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, Navarra, Spain
Hospital Universitario Gregorio Marañón, Madrid, , Spain
Hospital Universitario Ramón y Cajal, Madrid, , Spain
Hospital Infanta Sofía, Madrid, , Spain
Contact Details
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR
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