title: INvolvement of breast CAncer patients during oncological consultations: a multicentre randomised controlled trial--the INCA study protocol.
abstract: BACKGROUND
  Studies on patient involvement show that physicians make few attempts to involve their patients who ask few questions if not facilitated. On the other hand, the patients who participate in the decision-making process show greater treatment adherence and have better health outcomes. Different methods to encourage the active participation during oncological consultation have been described; however, similar studies in Italy are lacking. The aims of the present study are to (1) assess the effects of a preconsultation intervention to increase the involvement of breast cancer patients during the consultation, and (2) explore the role of the attending companions in the information exchange during consultation.
  
  
  METHODS
  All female patients with breast cancer who attend the Oncology Out-patient Services for the first time will provide an informed consent to participate in the study. They are randomly assigned to the intervention or to the control group. The intervention consists of the presentation of a list of relevant illness-related questions, called a question prompt sheet. The primary outcome measure of the efficacy of the intervention is the number of questions asked by patients during the consultation. Secondary outcomes are the involvement of the patient by the oncologist; the patient's perceived achievement of her information needs; the patient's satisfaction and ability to cope; the quality of the doctor-patient relationship in terms of patient-centeredness; and the number of questions asked by the patient's companions and their involvement during the consultation. All outcome measures are supposed to significantly increase in the intervention group.
  
  
  BACKGROUND
  The study was approved by the local Ethics Committee of the Hospital Trust of Verona. Study findings will be disseminated through peer-reviewed publications and conference presentations.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier: NCT01510964.
authors: Department of Public Health and Community Medicine, Section of Clinical Psychology, University of Verona, Verona, Italy.
authors: Claudia
authors: C
authors: Goss
authors: Alberto
authors: A
authors: Ghilardi
authors: Giuseppe
authors: G
authors: Deledda
authors: Chiara
authors: C
authors: Buizza
authors: Alessandro
authors: A
authors: Bottacini
authors: Lidia
authors: L
authors: Del Piccolo
authors: Michela
authors: M
authors: Rimondini
authors: Federica
authors: F
authors: Chiodera
authors: Maria Angela
authors: MA
authors: Mazzi
authors: Mario
authors: M
authors: Ballarin
authors: Irene
authors: I
authors: Bighelli
authors: Maria Grazia
authors: MG
authors: Strepparava
authors: Annamaria
authors: A
authors: Molino
authors: Elena
authors: E
authors: Fiorio
authors: Rolando
authors: R
authors: Nortilli
authors: Chiara
authors: C
authors: Caliolo
authors: Serena
authors: S
authors: Zuliani
authors: Alessandra
authors: A
authors: Auriemma
authors: Federica
authors: F
authors: Maspero
authors: Edda Lucia
authors: EL
authors: Simoncini
authors: Fulvio
authors: F
authors: Ragni
authors: Richard
authors: R
authors: Brown
authors: Christa
authors: C
authors: Zimmermann
keywords: breast cancer; docotr-pateint communication; patient involvement
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