Attitudes toward participating in Phase I clinical trials: an investigation with patient-family-physician triads.
OBJECTIVE
Phase I oncology trials have raised concerns that patients' 'unrealistic' optimism could compromise the validity of informed consent, and that patients often participate in trials to conform to physicians' or family members' recommendations. We aimed to determine whether patients or families-given the same information of risk-benefit profile-are more likely to participate in Phase I trials than their physicians and whether people in family or physician situations are more likely to recommend trial participation to patients than they would want for themselves as patients.


METHODS
We conducted a hypothetical vignette study with a patient-caregiver-oncologist. Three groups-725 patient-caregiver pairs recruited by 134 oncologists-were asked to assume three different roles as patients, caregivers and physicians and provided a scenario of a hypothetical patient with treatment-resistant cancer. They were asked questions regarding their intention to participate in or to recommend a Phase I clinical trial.


RESULTS
Acceptance rates of the trial were as follows: (a) in the patients' role: patients (54.1), caregivers (62.3) and physicians (63.4%); (b) in the caregivers' role: 55.6, 64.7 and 70.9%; (c) in the physicians' role: 66.1, 70.8 and 76.1%. Patients or caregivers were not more positive to the trial than physicians. All three groups showed more positive attitudes toward the clinical trial when they assumed the role of caregiver or physician than that of patient.


CONCLUSIONS
Patients and caregivers seem to make as reasonable decisions as physicians; patients seem to take family members' or physicians' recommendation as their legitimate roles rather than as undue pressure.
Department of Family Medicine and Health Promotion Center, Seoul National University Hospital, Seoul.|Cancer Survivorship Clinic, Seoul National University Cancer Hospital, Seoul.
Dong Wook
DW
Shin
Cancer Education Center, Samsung Comprehensive Cancer Center, School of Medicine and SAHIST, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.|Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.|Department of Health, Behavior, and Society, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Juhee
J
Cho
National Cancer Control Institute, National Cancer Center, Goyang-si.|College of Medicine/Graduate School of Health Science Business convergence, Chungbuk National University, Cheongju, Korea.
So Young
SY
Kim
National Cancer Control Institute, National Cancer Center, Goyang-si.
Hyung Kook
HK
Yang
Department of Family Medicine and Health Promotion Center, Seoul National University Hospital, Seoul.|Cancer Survivorship Clinic, Seoul National University Cancer Hospital, Seoul.
BeLong
B
Cho
Department of Internal Medicine, Gachon University School of Medicine, Incheon.
Dong-Bok
DB
Shin
Department of Radiation Oncology, Ajou University School of Medicine, Suwon.
Mi Son
MS
Chun
Department of Internal Medicine, Ulsan University Hospital, Ulsan.
Young Joo
YJ
Min
Gastric Cancer Branch, Research Institute and Hospital, National Cancer Center, Goyang, Republic of Korea.
Young-Woo
YW
Kim
National Cancer Control Institute, National Cancer Center, Goyang-si.|College of Medicine/Graduate School of Health Science Business convergence, Chungbuk National University, Cheongju, Korea.
Jong Hyock
JH
Park
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use; D001290:Attitude; D017028:Caregivers / Q000523:psychology; D002986:Clinical Trials as Topic; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy / Q000523:psychology*; D010819:Physician's Role; D010817:Physician-Patient Relations; D010820:Physicians / Q000523:psychology*
D000970:Antineoplastic Agents
Phase I clinical trial; attitudes; cancer; oncology