This revised grant application seeks to study, and address, the ethical dilemmas created by the participation of advanced cancer patients as research subjects in phase I trials of experimental agents. The ethical principles that provide the framework for study in this application are those principles that must guide all forms of clinical research. However, in the case of phase I cancer trials, these principles create particularly challenging dilemmas because of the perceived potential vulnerability of a terminally-ill patient population involved as research subjects, the very low likelihood of measurable clinical benefit achieved by phase I trial participation, and the available survey and interview research data regarding outcomes, i.e., understanding, of several crucial elements of the informed consent process for these trials. While participation in phase I trials remains a medically and socially acceptable alternative for many advanced cancer patients, these dilemmas lead to significant obstacles that prevent an ideal environment of effective communication and decision making among potential research subjects and the involved physician-investigators. Thus, the following dilemmas, phrased as questions, will become the specific research focus of this continuation application: Are patients being used as a means to an end without their full consent and understanding? Are subjects being inadvertently deceived by their own overwhelming desires for therapeutic benefits, their lack of acceptance of a terminal prognosis and poor communication with the involved phase I investigators? Can interventions improve these subjects understanding of key elements of the informed consent process for phase I trials? The research approach to these questions will incorporate both the recognition of the ethical importance of advanced cancer patients'understanding of their (life-ending) disease and their alternatives to research participation. This application will build upon the principal investigator's prior efforts in studying these difficult issues, employing a variety of descriptive, validated, and intervention research methods to improve our understanding of how best to provide meaningful information about treatment choices and clinical research opportunities to those with advanced cancer.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
5R01CA087605-07
Application #
7615553
Study Section
Special Emphasis Panel (ZRG1-HOP-E (90))
Program Officer
Witherspoon, Kim
Project Start
2000-07-01
Project End
2012-04-30
Budget Start
2009-05-01
Budget End
2012-04-30
Support Year
7
Fiscal Year
2009
Total Cost
$309,872
Indirect Cost
Name
University of Chicago
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
005421136
City
Chicago
State
IL
Country
United States
Zip Code
60637
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Hlubocky, Fay J; Kass, Nancy E; Roter, Debra et al. (2018) Investigator Disclosure and Advanced Cancer Patient Understanding of Informed Consent and Prognosis in Phase I Clinical Trials. J Oncol Pract 14:e357-e367
Daugherty, Christopher K; Hlubocky, Fay J (2008) What are terminally ill cancer patients told about their expected deaths? A study of cancer physicians'self-reports of prognosis disclosure. J Clin Oncol 26:5988-93
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Hlubocky, Fay J; Ratain, Mark J; Wen, Ming et al. (2007) Complementary and alternative medicine among advanced cancer patients enrolled on phase I trials: a study of prognosis, quality of life, and preferences for decision making. J Clin Oncol 25:548-54
Daugherty, Christopher K; Fitchett, George; Murphy, Patricia E et al. (2005) Trusting God and medicine: spirituality in advanced cancer patients volunteering for clinical trials of experimental agents. Psychooncology 14:135-46
Daugherty, Christopher K; Steensma, David P (2003) Overcoming obstacles to hospice care: an ethical examination of inertia and inaction. J Clin Oncol 21:42s-45s
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Helft, Paul R; Hlubocky, Fay; Wen, Ming et al. (2003) Associations among awareness of prognosis, hopefulness, and coping in patients with advanced cancer participating in phase I clinical trials. Support Care Cancer 11:644-51