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

Abstract:

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.

journal_name

Jpn J Clin Oncol

authors

Shin DW,Cho J,Kim SY,Yang HK,Cho B,Shin DB,Chun MS,Min YJ,Kim YW,Park JH

doi

10.1093/jjco/hyw135

subject

Has Abstract

pub_date

2016-12-01 00:00:00

pages

1095-1101

issue

12

eissn

0368-2811

issn

1465-3621

pii

hyw135

journal_volume

46

pub_type

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