title: A new informed consent form model for cancer patients: preliminary results of a prospective study by the Italian Association of Medical Oncology (AIOM).
abstract: OBJECTIVE
  To document the preliminary validity of a new informed consent form (ICF) model in terms of face/content validity and feasibility, to collect patients' and oncologists' opinions on it, and to explore physicians' and patients' "knowledge", "opinions" about "the information exchanged".
  
  
  METHODS
  The working group for informed consent promoted by the Italian Association of Medical Oncology developed a new ICF model which was tested in ten Italian cancer centers. Patients and physicians received questionnaires on the new ICF model. Twenty-six independent oncologists were interviewed to collect their opinions.
  
  
  RESULTS
  Seventy eight cancer patients were enrolled: about 90% reported having received information about diagnosis and therapy and 80% about prognosis. About 63% of oncologists had no difficulty in administering the ICF. Oncologists used "correct terms" about diagnosis in 92% of patients with localized disease and in 90% with metastasis and about therapy in respectively 75.7% and 80%. About prognosis, oncologists used "vague" and "no information-no pertinent terms" in 79% of patients with localized disease and 92.5% of patients with metastasis.
  
  
  CONCLUSIONS
  The ICF seemed to have sufficient validity and feasibility.
  
  
  CONCLUSIONS
  This ICF model could mean that patients require oncologists to spend more time explaining the diagnosis, prognosis and treatment, increasing patient's opportunities to participate actively in the care process.
authors.affiliation: Medical Oncology, Perugia Hospital, Via Dottori 1, 06122 Perugia, Italy. stefania.gori@tin.it
authors.forename: Stefania
authors.initials: S
authors.lastname: Gori
authors.forename: Maria Teresa
authors.initials: MT
authors.lastname: Greco
authors.forename: Chiara
authors.initials: C
authors.lastname: Catania
authors.forename: Cinzia
authors.initials: C
authors.lastname: Colombo
authors.forename: Giovanni
authors.initials: G
authors.lastname: Apolone
authors.forename: Vittorina
authors.initials: V
authors.lastname: Zagonel
mesh_terms: D001291:Attitude of Health Personnel; D032962:Consent Forms; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007258:Informed Consent; D007558:Italy; D008297:Male; D008495:Medical Oncology; D009369:Neoplasms / Q000523:psychology*; D010361:Patients / Q000523:psychology*; D010820:Physicians; D011446:Prospective Studies; D015203:Reproducibility of Results; D012955:Societies, Medical; D011795:Surveys and Questionnaires