A Multi-faceted Approach to Improving Breast Cancer Outcomes in a Rural Population, and the Potential Impact of Patient Navigation.

UNLABELLED: The mastectomy rate in rural areas of the Northern Plains of the U.S. was 64 percent from 2000 through 2005. We implemented a breast cancer patient navigation (BPN) program in May 2007 to increase breast conservation (BC) rates. METHODS: We analyzed mastectomy and BC rates among our 1,466 patients with either ductal carcinoma in situ (DCIS) or stage I/II invasive breast cancer treated from 2000 through 2012. We used interrupted time series (ITS) to compare rates in treatment following implementation of BPN. In addition, breast conservation rates were compared to population data from the Surveillance, Epidemiology, and End Results (SEER) database. RESULTS: The BC rates were 56 percent for navigated patients versus 37 percent for non-navigated patients (95 percent CI for difference: 14.8 to 25.6 percent). There was a consistent annual increase in treatment with BC versus a mastectomy (+2.9 percent/year, p-trend < 0.001). The BC rate of 60 percent in 2012 now mirrors those observed in the SEER database. The ITS did not find that the change in BC rates over time was significantly attributable to implementation of the BPN. Other secular trends may have contributed to the change in BC rates over time. CONCLUSIONS: A number of factors may have contributed to an increase of BC rates over time, including physician and patient education, more radiation therapy options, and possibly a dedicated breast cancer PN program. This analysis demonstrates that overall breast cancer care among this rural and medically-underserved population is improving in our region and now parallels other regions of the country.

Involving American Indians and medically underserved rural populations in cancer clinical trials.

PURPOSE: To assess cancer clinical trial recruitment and reasons for nonaccrual among a rural, medically underserved population served by a community-based cancer care center. METHODS: We prospectively tracked clinical trial enrollment incidence among all new patients presenting at the Rapid City Regional Cancer Care Institute. Evaluating physicians completed questionnaires for each patient regarding clinical trial enrollment status and primary reasons for nonenrollment. Patients who identified as American Indian were referred to a program where patients were assisted in navigating the medical system by trained, culturally competent staff. RESULTS: Between September 2006 and January 2008, 891 new cancer patients were evaluated. Seventy-eight patients (9%; 95% confidence intervals, 7-11%) were enrolled on a clinical treatment trial. For 73% (95% confidence intervals, 69-75%) of patients (646 of 891) lack of relevant protocol availability or protocol inclusion criteria restrictiveness was the reason for nonenrollment. Only 45 (5%; 95% confidence intervals, 4-7%) patients refused enrollment on a trial. Of the 78 enrolled on a trial, 6 (8%; 95% confidence intervals, 3-16%) were American Indian. Three additional American Indian patients were enrolled under a nontreatment cancer control trial, bringing the total percentage enrolled of the 94 American Indians who presented to the clinic to 10% (95% confidence intervals, 5-17%). LIMITATIONS: Eligibility rates were unable to be calculated and cross validation of the number in the cohort via registries or ICD-9 codes was not performed. CONCLUSION: Clinical trial participation in this medically underserved population was low overall, but approximately 3-fold higher than reported national accrual rates. Lack of availability of protocols for common cancer sites as well as stringent protocol inclusion criteria were the primary obstacles to clinical trial enrollment. Targeted interventions using a Patient Navigation program were used to engage AI patients and may have resulted in higher clinical trial enrollment among this racial/ethnic group.