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Jpn J Clin Oncol. 2016 Dec;46(12):1095-1101. Epub 2016 Sep 27.

Attitudes toward participating in Phase I clinical trials: an investigation with patient-family-physician triads.

Shin DW1,2, Cho J3,4,5, Kim SY6,7, Yang HK6, Cho B1,2, Shin DB8, Chun MS9, Min YJ10, Kim YW11, Park JH6,7.

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Department of Family Medicine and Health Promotion Center, Seoul National University Hospital, Seoul.
Cancer Survivorship Clinic, Seoul National University Cancer Hospital, Seoul.
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.
National Cancer Control Institute, National Cancer Center, Goyang-si.
College of Medicine/Graduate School of Health Science Business convergence, Chungbuk National University, Cheongju, Korea.
Department of Internal Medicine, Gachon University School of Medicine, Incheon.
Department of Radiation Oncology, Ajou University School of Medicine, Suwon.
Department of Internal Medicine, Ulsan University Hospital, Ulsan.
Gastric Cancer Branch, Research Institute and Hospital, National Cancer Center, Goyang, Republic of Korea.



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.


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.


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.


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.


Phase I clinical trial; attitudes; cancer; oncology

[Indexed for MEDLINE]

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