Colorectal Cancer Health Services Research Study Protocol: the CCR-CARESS Observational Prospective Cohort Project José M
Quintana et al. BMC Cancer (2016) 16:435 DOI 10.1186/s12885-016-2475-y STUDYPROTOCOL Open Access Colorectal cancer health services research study protocol: the CCR-CARESS observational prospective cohort project José M. Quintana1,8* , Nerea Gonzalez1,8, Ane Anton-Ladislao1,8, Maximino Redondo2,8, Marisa Bare3,8, Nerea Fernandez de Larrea4,8, Eduardo Briones5, Antonio Escobar6,8, Cristina Sarasqueta7,8, Susana Garcia-Gutierrez1,8, Urko Aguirre1,8 and for the REDISSEC-CARESS/CCR group Abstract Background: Colorectal cancers are one of the most common forms of malignancy worldwide. But two significant areas of research less studied deserve attention: health services use and development of patient stratification risk tools for these patients. Methods: Design: a prospective multicenter cohort study with a follow up period of up to 5 years after surgical intervention. Participant centers: 22 hospitals representing six autonomous communities of Spain. Participants/Study population: Patients diagnosed with colorectal cancer that have undergone surgical intervention and have consented to participate in the study between June 2010 and December 2012. Variables collected include pre-intervention background, sociodemographic parameters, hospital admission records, biological and clinical parameters, treatment information, and outcomes up to 5 years after surgical intervention. Patients completed the following questionnaires prior to surgery and in the follow up period: EuroQol-5D, EORTC QLQ-C30 (The European Organization for Research and Treatment of Cancer quality of life questionnaire) and QLQ-CR29 (module for colorectal cancer), the Duke Functional Social Support Questionnaire, the Hospital Anxiety and Depression Scale, and the Barthel Index. The main endpoints of the study are mortality, tumor recurrence, major complications, readmissions, and changes in health-related quality of life at 30 days and at 1, 2, 3 and 5 years after surgical intervention.
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