Proposing phase I studies: Patients', relatives', nurses' and specialists' perceptions

Purpose:As of now the primary objective of studies on informedconsent in phase I trials has been to assess patients' expectations andreasons for participation. We have previously shown that the quantity ofinformation provided through a procedure of subsequent oral interviews withpatients was adequate while the attention paid by the physician to theemotional needs and concerns of patients was not. We wanted therefore toassess and compare the perceptions of the information provided about theinvestigational study of patients, relatives, the research nurse and theinvestigator responsible for the phase I trial and the impact this informationhad on the patients' level of anxiety and depression.Patients and methods:The participation to a phase I study wasproposed to patients through two subsequent interviews, the latter attendedalso by patients' relatives, the research nurse and the investigatorcoordinating the phase I trial. After the second interview, attendees wererequested to complete a questionnaire assessing the principal reason forparticipating in the study and the informative, emotional and interactivedimension of the information. Patients were also requested to complete theHospital Anxiety and Depression (HAD) scale before and after the secondinterview.Results:The completed questionnaires of 31 of 42 patients wereretrieved and analysed. The possibility to benefit from the study wasindicated as the main reason for participating by 59% of the patientswhile it was judged to be the case in 78% and 86% of thepatients by the nurse and the investigator, respectively. The information wasjudged to be clear and sufficient in almost all cases by all attendees, whilethe investigator judged that a lower percentage of patients felt at ease andcould express their main worries during the interview, had been helped andwere 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 theinformation provided.Conclusions:Informing patients on the option of receiving aninvestigational treatment within a phase I study is feasible and can be donein a way felt appropriate by patients and relatives, nursing and medicalprofessionals. Providing information in an appropriate manner does notincrease patients' anxiety and depression. Divergence between the aims andinterests of the investigators and patients might explain the difference inthe evaluation of physician, a problem which could perhaps be partiallyovercome by the application of innovative phase I designs.