Perceptions of cancer patients and their physicians involved in phase I trials.
OBJECTIVE
In an attempt to understand some of the complex issues related to the participation of cancer patients in phase I trials, and the perceptions of patients toward these trials, we conducted a pilot survey study of 30 cancer patients who had given informed consent to participate in a phase I trial at our institution. Concurrently, the oncologists identified by the surveyed patients as responsible for their care were surveyed as well.


METHODS
Twenty-seven of 30 consecutive patients agreed to and completed the survey. Patients were surveyed before they received any investigational agents. Eighteen oncologists participated in this survey study.


RESULTS
Eighty-five percent of patients decided to participate in a phase I trial for reasons of possible therapeutic benefit, 11% because of advice/trust of physicians, and 4% because of family pressures. Ninety-three percent said that they understood all (33%) or most (60%) of the information provided about the trials in which they had decided to participate. Only 33% were able to state the purpose of the trial in which they were participating, with patients able to state the purpose of phase I trials being more educated (P = .01). Surveyed oncologists had wide-ranging beliefs regarding expectations of possible benefits and toxicities for their patients participating in phase I trials.


CONCLUSIONS
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.
Daugherty
C
C
Department of Medicine, University of Chicago Pritzker School of Medicine, IL, USA.
Ratain
M J
MJ
Grochowski
E
E
Stocking
C
C
Kodish
E
E
Mick
R
R
Siegler
M
M
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use; D001291:Attitude of Health Personnel; D001294:Attitude to Health; D017321:Clinical Trials, Phase I as Topic; D032882:Comprehension; D003625:Data Collection; D030881:Disclosure; D004522:Educational Status; D005260:Female; D006801:Humans; D007258:Informed Consent; D017567:Karnofsky Performance Status; D008297:Male; D008495:Medical Oncology; D008875:Middle Aged; D009042:Motivation; D033281:Nontherapeutic Human Experimentation; D026684:Personal Autonomy; D010865:Pilot Projects; D012107:Research Design; D035842:Research Subjects; D018570:Risk Assessment; D011795:Surveys and Questionnaires; D035502:Trust; D014342:Truth Disclosure
D000970:Antineoplastic Agents