Perceptions of cancer patients and their physicians involved in phase I trials.

Abstract

Cancer patients who participate in phase I trials are strongly motivated by the hope of therapeutic benefit. Altruistic feelings appear to have a limited and inconsequential role in motivating patients to participate in these trials. Cancer patients who participate in phase I trials appear to have an adequate self-perceived knowledge of the risks of investigational agents. However, only a minority of patients appear to have an adequate understanding of the purpose of phase I trials as dose-escalation/dose-determination studies.

Patients in phase I trials of anti-cancer agents in Japan: motivation, comprehension and expectations

“…For example, PSC 833 is targeted to the patients who are potentially resistant to vinca alkaloids or anthracyclines with multidrug resistance (MDR) overexpression. The result of our study, in which about half of patients did not appear to understand the purpose of phase I trials completely, seems similar to the result reported by Daugherty et al (1995) who asked both open-ended and closed questions (Daugherty et al, 1995). While it is absolutely essential that patients understand the purpose as well as the details of the method and possible risks and benefits of the clinical trials, patients who have incurable cancer may not be receptive to information on the theoretical basis of clinical trials and they are focused more on how these will affect them, not the scientific methodology.…”

“…The possibility of treatment-related risks and side-effects are well recognized after informed consent is given even by patients in phase II1III studies (Penman et al, 1984). It should be emphasized that these results are in accord with those found in a study in the United States (Daugherty et al, 1995). Almost all patients in our institution seemed to have understood the voluntary nature of participation in phase I trials.…”

“…In other words, all patients in this study were aware that they were participating in clinical research and almost all understood the major issues of a phase I trial, such as the unknown risks and uncertain benefits, but they may nevertheless have tended to be concemed about the details of method, possible risks and their own benefit rather than theoretical purposes. In general, patients who understand the basic concepts of the treatment tend to be younger and better educated (Daugherty et al, 1995;Cassileth et al, 1980;Lavelle-Jones et al, 1993). However, in our study, accurate identification of the purpose of a phase I trial did not correlate with educational level and age.…”

“…Although almost all investigators and institutional review boards agree as to the importance of informed consent (Kodish et al, 1992) and the guiding concept in ethical clinical research is informed consent, which is meant to guarantee the voluntary Received 31 May 1996 Revised 25 November 1996 Accepted 11 December 1996 Correspondence to: K Itoh nature of participation in clinical trials, there have been only a few reports from the viewpoint of the patients in phase I clinical trials of anti-cancer agents (Rodenhuis et al, 1984;Tomamichel et al, 1995;Daugherty et al, 1995). Furthermore, it is of interest to learn whether the patients' perception of these studies in Japan differs from that of patients in the United States and Europe.…”

The Role of Clinical Trial Participation in Cancer Research: Barriers, Evidence, and Strategies

“…15 However the majority of patients are (appropriately) concerned primarily with finding the best possible treatment for their disease. 15,39,40 In the absence of other barriers, a patient who believes that the best possible treatment option is to be found in a clinical trial is more likely to participate in that clinical trial. 33 …”