title: Diagnostic and treatment delay, quality of life and satisfaction with care in colorectal cancer patients: a study protocol.
abstract: 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
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Clinical Epidemiology and Biostatistics Unit, Complexo Hospitalario Universitario A Coruña, Universidade de A Coruña, Hotel de Pacientes 7a Planta, As Xubias 84, A Coruña, Spain. salvador.pita.fernandez@sergas.es
authors.forename: Salvador
authors.initials: S
authors.lastname: Pita-Fernández
authors.forename: Sonia
authors.initials: S
authors.lastname: Pértega-Díaz
authors.forename: Beatriz
authors.initials: B
authors.lastname: López-Calviño
authors.forename: Teresa
authors.initials: T
authors.lastname: Seoane-Pillado
authors.forename: Esther
authors.initials: E
authors.lastname: Gago-García
authors.forename: Rocío
authors.initials: R
authors.lastname: Seijo-Bestilleiro
authors.forename: Paloma
authors.initials: P
authors.lastname: González-Santamaría
authors.forename: Alejandro
authors.initials: A
authors.lastname: Pazos-Sierra
mesh_terms: D015179:Colorectal Neoplasms / Q000175:diagnosis* / Q000628:therapy*; D057210:Delayed Diagnosis; D005500:Follow-Up Studies; D006304:Health Status; D006801:Humans; D017060:Patient Satisfaction; D011446:Prospective Studies; D011788:Quality of Life; D013997:Time Factors