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Background  Due to recent improvements in colorectal cancer survival, patient-reported outcomes, including health-related quality of life and satisfaction with care, have become well-established endpoints to determine the impact of the disease on the lives of patients.  The aim of this study is to determine prospectively, in a cohort of colorectal cancer incident cases: a) health-related quality of life, b) satisfaction with hospital-based care, and c) functional status. A secondary objective is to determine whether diagnostic/therapeutic delay influence quality of life or patients’ satisfaction levels.    Methods/design  Single-centre prospective follow-up study of colorectal cancer patients diagnosed during the period 2011–2012 (n = 375).  This project was approved by the corresponding ethics review board, and informed consent is obtained from each patient. After diagnosis, patients are interviewed by a trained nurse, obtaining information on sociodemographic characteristics, family history of cancer, first symptoms, symptom perception and reaction to early symptoms. Quality of life is assessed with the EORTC QLQ-C30 and QLQ - CR29 questionnaires, and patients’ satisfaction with care is determined using the EORTC IN-PATSAT32. Functional status is measured with the Karnofsky Performance Status Scale.  Clinical records are also reviewed to collect information on comorbidity, tumour characteristics, treatment, hospital consultations and exploratory procedures.  Symptoms-to-diagnosis interval is defined as the time from the date of first symptoms until the cytohistological confirmation of cancer. Treatment delay is defined as the time between diagnosis and surgical treatment.  All the patients will be followed-up for a maximum of 2 years. For survivors, assessments will be re-evaluated at one and two years after the diagnosis.  Multiple linear/logistic regression models will be used to identify variables associated with the patients’ functional status, quality of life and satisfaction with care score. Changes in quality of life over time will be analysed with linear mixed-effects regression models.    Discussion  The results will provide a deeper understanding of the impact of colorectal cancer from a more patient-centred approach, allowing us to identify groups of patients in need of additional attention, as well as areas for improvement. Special attention will be given to the relationship between diagnostic/therapeutic delay and patients’ quality of life and satisfaction with the care received.

Diagnostic and treatment delay, quality of life and satisfaction with care in colorectal cancer patients: a study protocol