Factors and outcomes of decision making for cancer clinical trial participation.

PURPOSE/OBJECTIVES: To describe factors and outcomes related to the decision-making process regarding participation in a cancer clinical trial.

DESIGN

Cross-sectional, descriptive.

SETTING

Urban, academic, National Cancer Institute-designated comprehensive cancer center in the mid-Atlantic United States.

SAMPLE

197 patients with advanced gastrointestinal cancer.

METHODS

Mailed survey using one investigator-developed instrument, eight instruments used in published research, and a medical record review.

INDEPENDENT VARIABLES

disease context, sociodemographics, hope, quality of life, trust in healthcare system, trust in health professional, preference for research decision control, understanding risks, and information.

DEPENDENT VARIABLES

decision to accept or decline research participation and satisfaction with this decision.

FINDINGS

All of the factors within the Research Decision Making Model together predicted cancer clinical trial participation and satisfaction with this decision. The most frequently preferred decision-making style for research participation was shared (collaborative) (83%).

CONCLUSIONS

Multiple factors affect decision making for cancer clinical trial participation and satisfaction with this decision. Shared decision making previously was an unrecognized factor and requires further investigation.

IMPLICATIONS FOR NURSING

Enhancing the process of research decision making may facilitate an increase in cancer clinical trial enrollment rates. Oncology nurses have unique opportunities as educators and researchers to support shared decision making by those who prefer this method for deciding whether to accept or decline cancer clinical trial participation.