A new informed consent form model for cancer patients: preliminary results of a prospective study by the Italian Association of Medical Oncology (AIOM).

ABSTRACT

OBJECTIVES: 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. PRACTICE IMPLICATION 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.