title: The effectiveness of the quality program Pac-IficO to improve pain management in hospitalized cancer patients: a before-after cluster phase II trial.
abstract: BACKGROUND
  Cancer-related pain continues to be a major healthcare issue worldwide. Despite the availability of effective analgesic drugs, published guidelines and educational programs for Health Care Professionals (HCPs) the symptom is still under-diagnosed and its treatment is not appropriate in many patients. The objective of the study is to evaluate the efficacy of the Pac-IFicO programme in improving the quality of pain management in hospitalised cancer patients.
  
  
  METHODS
  This is a before-after cluster phase II study. After the before assessment, the experimental intervention - the Pac-IFicO programme - will be implemented in ten medicine, oncology and respiratory disease hospital wards. The same assessment will be repeated after the completion of the intervention. The Pac-IFicO programme is a complex intervention with multiple components. It includes focus group with ward professionals for identifying possible local obstacles to optimal pain control, informative material for the patients, an educational program performed through guides from the wards, and an organisational intervention to the ward. The primary end-point of the study is the proportion of cancer patients with severe pain. Secondary end-points include opioids administered in the wards, knowledge in pain management, and quality of pain management. We plan to recruit about 500 cancer patients. This sample size should be sufficient, after appropriate statistical adjustments for clustering, to detect an absolute decrease in the primary end-point from 20% to 9%.
  
  
  CONCLUSIONS
  This trial is aimed at exploring with an experimental approach the efficacy of a new quality improvement educational intervention.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT02035098.
authors.affiliation: Supportive Care in Cancer Unit, Department of Hematology and Pediatric Onco-Hematology, Fondazione IRCCS, Istituto Nazionale dei Tumori, Milano, Italy. carla.ripamonti@istitutotumori.mi.it.
authors.forename: Carla Ida
authors.initials: CI
authors.lastname: Ripamonti
authors.forename: Cesarina
authors.initials: C
authors.lastname: Prandi
authors.forename: Massimo
authors.initials: M
authors.lastname: Costantini
authors.forename: Elisa
authors.initials: E
authors.lastname: Perfetti
authors.forename: Fabio
authors.initials: F
authors.lastname: Pellegrini
authors.forename: Marco
authors.initials: M
authors.lastname: Visentin
authors.forename: Lorenza
authors.initials: L
authors.lastname: Garrino
authors.forename: Anna
authors.initials: A
authors.lastname: De Luca
authors.forename: Maria Adelaide
authors.initials: MA
authors.lastname: Pessi
authors.forename: Carlo
authors.initials: C
authors.lastname: Peruselli