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The culture of faith and hope†

Patients' justifications for their high estimations of expected therapeutic benefit when enrolling in early phase oncology trials

  1. Daniel P. Sulmasy MD, PhD1,‡,*,
  2. Alan B. Astrow MD2,
  3. M. Kai He PhD3,
  4. Damon M. Seils MA4,
  5. Neal J. Meropol MD5,
  6. Ellyn Micco MS6,
  7. Kevin P. Weinfurt PhD4,7

Article first published online: 29 APR 2010

DOI: 10.1002/cncr.25201

Issue

Cancer

Cancer

Volume 116, Issue 15, pages 3702–3711, 1 August 2010

Additional Information

How to Cite

Sulmasy, D. P., Astrow, A. B., He, M. K., Seils, D. M., Meropol, N. J., Micco, E. and Weinfurt, K. P. (2010), The culture of faith and hope. Cancer, 116: 3702–3711. doi: 10.1002/cncr.25201

Author Information

  1. 1

    Department of Medicine, MacLean Center for Clinical Medical Ethics, Divinity School, University of Chicago, Chicago, Illinois

  2. 2

    Maimonides Medical Center, New York, New York

  3. 3

    St. Vincent's Hospital Manhattan, New York, New York

  4. 4

    Duke Clinical Research Institute, Duke University, Durham, North Carolina

  5. 5

    Case Comprehensive Cancer Center, Cleveland, Ohio

  6. 6

    Fox Chase Cancer Center, Philadelphia, Pennsylvania

  7. 7

    Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, North Carolina

  1. ‡

    Fax: (773) 702-0072

*MacLean Center for Clinical Medical Ethics, University of Chicago, MC 6098, 5841 S Maryland Ave, Chicago, IL 60637

  1. †

    Presented at the Society for General Internal Medicine 32nd Annual Meeting, Miami Beach, Florida, May 13-16, 2009.The content of this article is solely the responsibility of the authors and does not necessarily represent the official views of the National Cancer Institute or the National Institutes of Health.

  2. ‡

    Fax: (773) 702-0072

Publication History

  1. Issue published online: 20 JUL 2010
  2. Article first published online: 29 APR 2010
  3. Manuscript Revised: 17 NOV 2009
  4. Manuscript Accepted: 17 NOV 2009
  5. Manuscript Received: 4 AUG 2009

Funded by

  • National Cancer Institute. Grant Number: R01CA100771

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Keywords:

  • clinical trials as topic;
  • communication;
  • decision making;
  • neoplasms;
  • religion and medicine

Abstract

BACKGROUND:

Patients' estimates of their chances of therapeutic benefit from participation in early phase trials greatly exceed historical data. Ethicists worry that this therapeutic misestimation undermines the validity of informed consent.

METHODS:

The authors interviewed 45 patients enrolled in phase 1 or 2 oncology trials about their expectations of therapeutic benefit and their reasons for those expectations. They used a phenomenological, qualitative approach with 1 primary coder to identify emergent themes, verified by 2 independent coders.

RESULTS:

Median expectations of therapeutic benefit varied from 50% to 80%, depending on how the question was asked. Justifications universally invoked hope and optimism, and 27 of 45 participants used 1 of these words. Three major themes emerged: 1) optimism as performative, that is, the notion that positive thoughts and expressions improve chances of benefit; 2) fighting cancer as a battle; and 3) faith in God, science, or both. Many participants described a culture in which optimism was encouraged and expected, such that trial enrollment became a way of reflecting this expectation. Many reported they had been told few patients would benefit and appeared to understand the uncertainties of clinical research, yet expressed high expected personal therapeutic benefit. More distressed participants were less likely to invoke performative justifications for their expectations (50% vs 84%; P = .04).

CONCLUSIONS:

Expressions of high expected therapeutic benefit had little to do with reporting knowledge and more to do with expressing optimism. These results have implications for understanding how to obtain valid consent from participants in early phase clinical trials. Cancer 2010. © 2010 American Cancer Society.

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