title: A cluster randomized trial evaluating the efficacy of patient navigation in improving quality of diagnostic care for patients with breast or colorectal cancer abnormalities.
abstract: BACKGROUND
  This study examines efficacy of a lay patient navigation (PN) program aimed to reduce time between a cancer abnormality and definitive diagnosis among racially/ethnically diverse and medically underserved populations of Tampa Bay, Florida.
  
  
  METHODS
  Using a cluster randomized design, the study consisted of 11 clinics (six navigated; five control). Patients were navigated from time of a breast or colorectal abnormality to diagnostic resolution, and to completion of cancer treatment. Using a generalized mixed-effects model to assess intervention effects, we examined: (i) length of time between abnormality and definitive diagnosis, and (ii) receipt of definitive diagnosis within the 6-month minimum follow-up period.
  
  
  RESULTS
  A total of 1,267 patients participated (588 navigated; 679 control). We also included data from an additional 309 chart abstractions (139 navigated arm; 170 control arm) that assessed outcomes at baseline. PN did not have a significant effect on time to diagnostic resolution in multivariable analysis that adjusted for race-ethnicity, language, insurance status, marital status, and cancer site (P = 0.16). Although more navigated patients achieved diagnostic resolution by 180 days, results were not statistically significant (74.5% navigated vs. 68.5% control, P = 0.07).
  
  
  CONCLUSIONS
  PN did not impact the overall time to completion of diagnostic care or the number of patients who reached diagnostic resolution of a cancer abnormality. Further evaluation of PN programs applied to other patient populations across the cancer continuum is necessary to gain a better perspective on its effectiveness.
  
  
  CONCLUSIONS
  PN programs may not impact timely resolution of an abnormality suspicious of breast or colorectal cancer.
authors.affiliation: University of South Florida, 12901 Bruce B. Downs Blvd., MDC 27, Tampa, FL 33612, USA. kwells1@health.usf.edu
authors.forename: Kristen J
authors.initials: KJ
authors.lastname: Wells
authors.forename: Ji-Hyun
authors.initials: JH
authors.lastname: Lee
authors.forename: Ercilia R
authors.initials: ER
authors.lastname: Calcano
authors.forename: Cathy D
authors.initials: CD
authors.lastname: Meade
authors.forename: Marlene
authors.initials: M
authors.lastname: Rivera
authors.forename: William J
authors.initials: WJ
authors.lastname: Fulp
authors.forename: Richard G
authors.initials: RG
authors.lastname: Roetzheim
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001943:Breast Neoplasms / Q000175:diagnosis*; D015179:Colorectal Neoplasms / Q000175:diagnosis*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D062526:Patient Navigation; D011787:Quality of Health Care; D013997:Time Factors