"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.

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."