Introduction: Patient navigation is an intervention designed to assist patients in overcoming barriers to achieving a defined health outcome. This study examined the efficacy of a culturally appropriate lay patient navigation program aimed at reducing the time between a breast or colorectal cancer screening abnormality and definitive diagnosis among racially and ethnically diverse, farmworker, and other medically underserved populations of Tampa Bay, Florida.

Methods: The study was guided by a Community Advisory Board and was one of the sites in the National Cancer Institute-funded Patient Navigation Research Program (PNRP). A lay patient navigation model was designed based on community input and formative research. Using a cluster randomized design, patients were recruited from 12 primary care sites (7 sites randomized to navigation and 5 sites randomized to usual care) that included federally qualified health centers and hospital-affiliated primary care clinics. Health care providers in the sites randomized to patient navigation referred patients to the study. Participants in the control clinics were identified using provider referral, billing data, or logs of medical procedures. Five trained patient navigators provided services to patients from the time of a breast or colorectal cancer screening abnormality to diagnostic resolution of the abnormality, and throughout cancer treatment if a patient was diagnosed with cancer. Participants’ medical records were reviewed using a standardized form to collect data defined by the Patient Navigation Research Program data dictionary. Using a generalized mixed-effects model accounting for group randomized trial design to assess intervention effects relative to baseline data collected prior to the intervention, we examined: 1) length of time between abnormality and definitive diagnosis, and 2) receipt of definitive diagnosis within the minimum follow-up period of 6 months.

Results: A total of 1,267 patients participated in the study (588 navigated; 679 control). Most participants were Hispanic (57.8%) and female (94.2%). Seventy percent of participants achieved definitive diagnosis within 180 days. Navigated patients were more likely to reach diagnostic resolution by 180 days (74.5% of navigated patients versus 68.5% of control patients, p=0.007). Patient navigation did not have a statistically significant effect on time to diagnostic resolution in multivariable analysis that adjusted for race-ethnicity, language, insurance status, marital status, and cancer site (p=0.12).

Conclusions: Patient navigation is an important intervention to increase the number of patients who receive recommended diagnostic care within 180 days. Although patient navigation increased the rate of patients who received diagnostic resolution of a breast or colorectal screening abnormality, it did not significantly reduce the overall time needed to complete diagnostic care. Further evaluation of PN programs applied to other patient populations across the cancer continuum is necessary to gain a better perspective on its usefulness.

Acknowledgements: This study was funded by the National Cancer Institute through its Center to Reduce Cancer Health Disparities, National Institutes of Health, Department of Health and Human Services (Dr. Richard Roetzheim, PI; U01 CA 117281–01).

Citation Information: Cancer Epidemiol Biomarkers Prev 2011;20(10 Suppl):B100.