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.

Main Research Variables: 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.