title: Proposing phase I studies: patients', relatives', nurses' and specialists' perceptions.
abstract: OBJECTIVE
  As of now the primary objective of studies on informed consent in phase I trials has been to assess patients' expectations and reasons for participation. We have previously shown that the quantity of information provided through a procedure of subsequent oral interviews with patients was adequate while the attention paid by the physician to the emotional needs and concerns of patients was not. We wanted therefore to assess and compare the perceptions of the information provided about the investigational study of patients, relatives, the research nurse and the investigator responsible for the phase I trial and the impact this information had on the patients' level of anxiety and depression.
  
  
  METHODS
  The participation to a phase I study was proposed to patients through two subsequent interviews, the latter attended also by patients' relatives, the research nurse and the investigator coordinating the phase I trial. After the second interview, attendees were requested to complete a questionnaire assessing the principal reason for participating in the study and the informative, emotional and interactive dimension of the information. Patients were also requested to complete the Hospital Anxiety and Depression (HAD) scale before and after the second interview.
  
  
  RESULTS
  The completed questionnaires of 31 of 42 patients were retrieved and analysed. The possibility to benefit from the study was indicated as the main reason for participating by 59% of the patients while it was judged to be the case in 78% and 86% of the patients by the nurse and the investigator, respectively. The information was judged to be clear and sufficient in almost all cases by all attendees, while the investigator judged that a lower percentage of patients felt at ease and could express their main worries during the interview, had been helped and were less worried after it than it was judged by the nurse and the relatives. Patients' state of anxiety and depression was not adversely affected by the information provided.
  
  
  CONCLUSIONS
  Informing patients on the option of receiving an investigational treatment within a phase I study is feasible and can be done in a way felt appropriate by patients and relatives, nursing and medical professionals. Providing information in an appropriate manner does not increase patients' anxiety and depression. Divergence between the aims and interests of the investigators and patients might explain the difference in the evaluation of physician, a problem which could perhaps be partially overcome by the application of innovative phase I designs.
authors.affiliation: Department of Psychosocial Care, Lugano, Switzerland.
authors.forename: M
authors.initials: M
authors.lastname: Tomamichel
authors.forename: H
authors.initials: H
authors.lastname: Jaime
authors.forename: A
authors.initials: A
authors.lastname: Degrate
authors.forename: J
authors.initials: J
authors.lastname: de Jong
authors.forename: O
authors.initials: O
authors.lastname: Pagani
authors.forename: F
authors.initials: F
authors.lastname: Cavalli
authors.forename: C
authors.initials: C
authors.lastname: Sessa
mesh_terms: D000328:Adult; D000368:Aged; D001291:Attitude of Health Personnel; D001294:Attitude to Health; D017321:Clinical Trials, Phase I as Topic / Q000379:methods*; D005069:Evaluation Studies as Topic; D005260:Female; D006282:Health Personnel / Q000523:psychology; D006801:Humans; D007258:Informed Consent; D008297:Male; D008875:Middle Aged; D010344:Patient Advocacy; D017060:Patient Satisfaction; D010361:Patients / Q000523:psychology*; D010817:Physician-Patient Relations; D011795:Surveys and Questionnaires; D014342:Truth Disclosure