title: Early Palliative Care-Health services research and implementation of sustainable changes: the study protocol of the EVI project.
abstract: BACKGROUND
  International medical organizations such as the American Society of Medical Oncology recommend early palliative care as the "gold standard" for palliative care in patients with advanced cancer. Nevertheless, even in Comprehensive Cancer Centers, early palliative care is not yet routine practice. The main goal of the EVI project is to evaluate whether early palliative care can be implemented-in the sense of "putting evidence into practice"-into the everyday clinical practice of Comprehensive Cancer Centers. In addition, we are interested in (1) describing the type of support that patients would like from palliative care, (2) gaining information about the effect of palliative care on patients' quality of life, and (3) understanding the economic burden of palliative care on patients and their families.
  
  
  METHODS
  The EVI project is a multi-center, prospective cohort study with a sequential control group design. The study is a project of the Palliative Care Center of Excellence (KOMPACT) in Baden-Württemberg, Germany, which was recently established to combine the expertise of five academic, specialist palliative care departments. The study is divided into two phases: preliminary phase (months 1-9) and main study phase (months 10-18). In each of all five participating academic Comprehensive Cancer Centers, an experienced palliative care physician will be hired for 18 months. During the preliminary phase, the physician will be allowed time to establish the necessary structures for early palliative care within the Comprehensive Cancer Center. In the main study phase, patients with metastatic cancer will be offered a consultation with the palliative care physician within eight weeks of diagnosis. After the initial consultation, follow-up consultations will be offered as needed. The study is built upon a convergent parallel design. In the quantitative arm, patients will be surveyed in both the preliminary and main study phase at three points in time (baseline, 12 weeks, 24 weeks). Standardized questionnaires will be used to measure patients' quality of life, symptom burden and mood. Using interviews with palliative care physicians, oncologists, department heads, patients and their caregivers, the qualitative arm will explore (1) what factors encourage and hinder the early integration of palliative care into standard oncology care, (2) what support patients and their caregivers would like from palliative care, and (3) what effect palliative care has on the economic disease burden of patients and their families.
  
  
  CONCLUSIONS
  The study proposed is meant to serve as a catalyzer. Local palliative care teams should be put in position to routinely cooperate with the primary treating department at their respective cancer center. The long-term goal of this project is to create sustainable improvements in the care of patients with incurable cancer.
  
  
  BACKGROUND
  DRKS00006162 ; date of registration: 19/05/2014.
authors.affiliation: Department of Palliative Care, Comprehensive Cancer Center, University Medical Center Freiburg, Freiburg, Germany. cornelia.meffert@uniklinik-freiburg.de.|Department of Palliative Care, Palliative Care Research Group, University Medical Center Freiburg, Robert-Koch-Str. 3, 79106, Freiburg, Germany. cornelia.meffert@uniklinik-freiburg.de.
authors.forename: Cornelia
authors.initials: C
authors.lastname: Meffert
authors.affiliation: Department of Palliative Care, Comprehensive Cancer Center, University Medical Center Freiburg, Freiburg, Germany.|Palliative Care Center of Excellence for Baden-Wuerttemberg, Baden-Wuerttemberg, Germany.
authors.forename: Jan
authors.initials: J
authors.lastname: Gaertner
authors.affiliation: Department of Palliative Care, Comprehensive Cancer Center, University Medical Center Freiburg, Freiburg, Germany.
authors.forename: Katharina
authors.initials: K
authors.lastname: Seibel
authors.affiliation: Department of Palliative Care, Comprehensive Cancer Center, University Medical Center Freiburg, Freiburg, Germany.
authors.forename: Karin
authors.initials: K
authors.lastname: Jors
authors.affiliation: Palliative Care Center of Excellence for Baden-Wuerttemberg, Baden-Wuerttemberg, Germany.|Department of Anesthesiology, Comprehensive Cancer Center, University Medical Center Heidelberg, Heidelberg, Germany.
authors.forename: Hubert
authors.initials: H
authors.lastname: Bardenheuer
authors.affiliation: Palliative Care Center of Excellence for Baden-Wuerttemberg, Baden-Wuerttemberg, Germany.|Department of Hematology and Oncology, Comprehensive Cancer Center, Mannheim University Hospital, University of Heidelberg, Heidelberg, Germany.
authors.forename: Dieter
authors.initials: D
authors.lastname: Buchheidt
authors.affiliation: Palliative Care Center of Excellence for Baden-Wuerttemberg, Baden-Wuerttemberg, Germany.|Department of Hematology and Oncology, Comprehensive Cancer Center, University Medical Center Ulm, Ulm, Germany.
authors.forename: Regine
authors.initials: R
authors.lastname: Mayer-Steinacker
authors.affiliation: Palliative Care Center of Excellence for Baden-Wuerttemberg, Baden-Wuerttemberg, Germany.|Department of Radiation Oncology, Comprehensive Cancer Center, University Medical Center Tuebingen, Tuebingen, Germany.
authors.forename: Marén
authors.initials: M
authors.lastname: Viehrig
authors.affiliation: Paul-Lechler Hospital Tuebingen, Tuebingen, Germany.
authors.forename: Christina
authors.initials: C
authors.lastname: Paul
authors.affiliation: Institute of Health Economics and Clinical Epidemiology, University Clinic of Cologne (AöR), Cologne, Germany.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Stock
authors.affiliation: Department of Palliative Care, Comprehensive Cancer Center, University Medical Center Freiburg, Freiburg, Germany.
authors.forename: Carola
authors.initials: C
authors.lastname: Xander
authors.affiliation: Department of Palliative Care, Comprehensive Cancer Center, University Medical Center Freiburg, Freiburg, Germany.|Palliative Care Center of Excellence for Baden-Wuerttemberg, Baden-Wuerttemberg, Germany.
authors.forename: Gerhild
authors.initials: G
authors.lastname: Becker
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D005260:Female; D005858:Germany; D006801:Humans; D008297:Male; D008495:Medical Oncology; D008875:Middle Aged; D009362:Neoplasm Metastasis / Q000473:pathology; D009367:Neoplasm Staging; D009369:Neoplasms / Q000453:epidemiology* / Q000473:pathology / Q000628:therapy*; D010166:Palliative Care; D011446:Prospective Studies; D011788:Quality of Life; D011795:Surveys and Questionnaires; D000078329:Workforce