title: Randomized controlled trial of patient navigation for newly diagnosed cancer patients: effects on quality of life.
abstract: BACKGROUND
  Patient navigation is a promising intervention to ameliorate cancer health disparities. This study objective was to measure patient navigation effects on cancer-specific quality of life (QOL) among patients with newly diagnosed cancer.
  
  
  METHODS
  A randomized controlled trial of patient navigation was conducted in Rochester, NY. Patients with breast cancer and colorectal cancer were randomly assigned to receive a patient navigation intervention or usual care. QOL was measured at baseline and four subsequent time points, using the validated Functional Assessment of Cancer Therapy (FACT-B, FACT-C) instruments.
  
  
  RESULTS
  Among 319 randomized patients (165 patient navigation, 154 control), median age was 57 years and 32.5% were from minority race/ethnicity groups. Patient navigation and control groups were comparable on baseline factors, except home ownership versus renting (more home ownership among controls, P = 0.05) and race (more whites among controls, P = 0.05). Total and subscale FACT scores did not differ between groups when analyzed as a change from baseline to 3 months, or at various time points. The emotional well-being subscale change from baseline approached significance (better change among patient navigation group, P = 0.05). Time trends of QOL measures did not differ significantly between groups. Adjustment for baseline patient factors did not reveal a benefit of patient navigation on QOL.
  
  
  CONCLUSIONS
  In this randomized trial of patient navigation, there was no statistically significant effect on disease-specific QOL.
  
  
  CONCLUSIONS
  These results suggest that patient navigation may not affect QOL during cancer treatment, that social/medical support are adequate in this study's setting, or that the trial failed to target patients likely to experience QOL benefit from patient navigation.
authors.affiliation: Department of Surgery, Division of Medical Oncology, University of Michigan School of Medicine, Ann Arbor, MI 48109, USA. hendren@med.umich.edu
authors.forename: Samantha
authors.initials: S
authors.lastname: Hendren
authors.forename: Jennifer J
authors.initials: JJ
authors.lastname: Griggs
authors.forename: Ronald
authors.initials: R
authors.lastname: Epstein
authors.forename: Sharon
authors.initials: S
authors.lastname: Humiston
authors.forename: Pascal
authors.initials: P
authors.lastname: Jean-Pierre
authors.forename: Paul
authors.initials: P
authors.lastname: Winters
authors.forename: Mechelle
authors.initials: M
authors.lastname: Sanders
authors.forename: Starlene
authors.initials: S
authors.lastname: Loader
authors.forename: Kevin
authors.initials: K
authors.lastname: Fiscella
mesh_terms: D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000523:psychology* / Q000628:therapy; D015179:Colorectal Neoplasms / Q000523:psychology* / Q000628:therapy; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D062526:Patient Navigation; D011788:Quality of Life