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"I Had Already Made Up My Mind": Patients and Caregivers' Perspectives on Making the Decision to Participate in Research at a US Cancer Referral Center

Shannon-Dorcy, Kathleen PhD(c), MN, RN; Drevdahl, Denise J. PhD, RN

Cancer Nursing:
doi: 10.1097/NCC.0b013e318207cb03
Articles
Abstract

Background: Hematopoietic cell transplants (HCTs) are associated with high morbidity and mortality, which complicate the decision-making process for people considering HCT clinical trials. There is a lack of research examining longitudinally how patients make clinical trial participation decisions in US cancer referral centers.

Objective: A qualitative study was conducted to examine how patients and their family caregivers decide to participate in HCT research at a US cancer referral center.

Methods: Semistructured interviews were conducted with 25 patients enrolled in early-stage phase 2 HCT research studies and with 20 family caregivers. Interviews were conducted before HCT and approximately days 80 and 365 after HCT.

Results: Most patients (92%) and their caregivers (75%) decided to participate in research well before consent conferences at the cancer referral center. Patients' reasons for deciding to participate included having "no other option," seeking a cure, and following their home oncologists' recommendations.

Conclusion: Currently, US researchers are primarily guided by Federal regulations that view the decision-making process as a cognitive one. Findings confirmed cognition was a part of consent; however, most patients made the decision to participate in high-risk clinical trials long before they had been apprised of the specific information about the study and before the consent conference.

Implications for Practice: The high risk of death from the disease and/or the HCT underscored the emotional component of decision making and affirmed that researchers need to acknowledge this emotional component to meet the ethical imperative of providing "informed consent."

Author Information

Author Affiliations: Fred Hutchinson Cancer Research Center, Seattle, Washington (Ms Shannon-Dorcy); and Nursing Program, University of Washington, Tacoma (Dr Drevdahl).

Research supported by a grant from the National Institute of Nursing Research (1 R21 R21NR00947).

The authors have no conflicts of interest to disclose.

Correspondence: Kathleen Shannon-Dorcy, PhD(c), MN, RN, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, 1100 Fairview Ave N, LF-210, PO Box 19024, Seattle, WA 98109-1024 (kshannon@fhcrc.org).

Accepted for publication November 20, 2010.

© 2011 Lippincott Williams & Wilkins, Inc.