title: Prospective, multicenter, randomized trial of a new organizational modality for providing information and support to cancer patients.
abstract: OBJECTIVE
  No structured modality for providing information and support to patients in oncology wards has been validated in clinical trials.
  
  
  METHODS
  This is a pragmatic, two-arm, cluster randomized trial, with the oncology ward as random assignment unit. Centers were allocated to implement a Point of Information and Support (PIS) or to a control group. The PIS included a library for cancer patients and a specifically trained oncology nurse. End points, measured at patient level, were psychological distress and satisfaction with received information. Both intent-to-treat and per-protocol analyses considering clustering were performed.
  
  
  RESULTS
  Thirty-eight Italian cancer centers were randomly assigned, and 6 months after PIS creation, 3,286 unselected, consecutive cancer patients were surveyed (1,654 in the experimental group and 1,632 in the control group). Three thousand one hundred ninety-seven (97%) questionnaires were collected and deemed valid. Fifty-two percent of centers (11 of 21 centers) in the experimental arm did not implement the PIS in accordance with the protocol. Overall, 34% of patients showed moderate to severe psychological distress, and only 9% declared dissatisfaction. Intent-to-treat analysis did not yield significant differences. Although the per-protocol analysis did show a reduction in psychological distress (28.9% for functioning PIS v 33.3% for no PIS) and dissatisfaction (6.4% for functioning PIS v 9.3% for no PIS), differences did not reach significance.
  
  
  CONCLUSIONS
  This is the first cluster randomized trial aiming to demonstrate that a structured modality of providing information reduces psychological distress. We did not find this, but we believe results should be interpreted cautiously, particularly because of the low compliance with PIS implementation. Context analysis preceding such interventions is essential.
authors.affiliation: Division of Medical Oncology, Istituti Ospitalieri, Cremona, Italy. r.passalacqua@ospedale.cremona.it
authors.forename: Rodolfo
authors.initials: R
authors.lastname: Passalacqua
authors.forename: Caterina
authors.initials: C
authors.lastname: Caminiti
authors.forename: Francesco
authors.initials: F
authors.lastname: Campione
authors.forename: Francesca
authors.initials: F
authors.lastname: Diodati
authors.forename: Renata
authors.initials: R
authors.lastname: Todeschini
authors.forename: Giancarlo
authors.initials: G
authors.lastname: Bisagni
authors.forename: Roberto
authors.initials: R
authors.lastname: Labianca
authors.forename: Matteo
authors.initials: M
authors.lastname: Dalla Chiesa
authors.forename: Raffaella
authors.initials: R
authors.lastname: Bracci
authors.forename: Marcello
authors.initials: M
authors.lastname: Aragona
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Artioli
authors.forename: Luigi
authors.initials: L
authors.lastname: Cavanna
authors.forename: Alceste
authors.initials: A
authors.lastname: Masina
authors.forename: Francesco
authors.initials: F
authors.lastname: De Falco
authors.forename: Barbara
authors.initials: B
authors.lastname: Marzocchini
authors.forename: Carmelo
authors.initials: C
authors.lastname: Iacono
authors.forename: Antonio
authors.initials: A
authors.lastname: Contu
authors.forename: Francesco
authors.initials: F
authors.lastname: Di Costanzo
authors.forename: Oscar
authors.initials: O
authors.lastname: Bertetto
authors.forename: Maria A
authors.initials: MA
authors.lastname: Annunziata
mesh_terms: D005260:Female; D006266:Health Education; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000523:psychology* / Q000628:therapy*; D009723:Nurse-Patient Relations; D010353:Patient Education as Topic; D017060:Patient Satisfaction; D010817:Physician-Patient Relations; D011446:Prospective Studies; D012944:Social Support; D013315:Stress, Psychological; D011795:Surveys and Questionnaires