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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

doi: 10.1097/NCC.0b013e318207cb03
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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 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.