Table 1.

Efficacy Studies of Patient Navigation for Colorectal Cancer Screening and Diagnosis

Authors (Year Published)	Research Design	Colorectal Cancer Test Type(s)	Location/PN Model/Population	Sample Size	Findings
Jandorf, Gutierrez, Lopez, Christie, and Itzkowitz (2005)	RCT	FOBT, FS, colonoscopy	Primary care practice in East Harlem, New York City, New York Navigators assisted patient with arranging for screening after physician referral for FOBT, FS, or colonoscopy; PN services included scheduling assistance, patient support and education, and written and telephone appointment reminders Population largely female, Hispanic, low income, and publicly insured	78	At 3-month postenrollment, 42.1% of navigated patients (n = 38) completed FOBTs compared to 25% in the control group (p = .086) At 6 months postenrollment, 23.7% of navigated patients who were referred by their physician for FS or colonoscopy completed an endoscopic examination compared to 5% of the control group (p < .02)
Nash, Azeez, Vlahov, and Schori (2006)	Historical comparison	Colonoscopy	Acute care hospital in the Bronx, New York City, New York Navigators assisted patients in arranging for screening after physician referral for colonoscopy; PN services included assistance with paperwork for preadmission testing, scheduling assistance, and appointment reminders; intervention also included direct endoscopic referral and enhancements to gastrointestinal suites Population largely female, Hispanic, low income, and publicly insured	1,767	Of the 1,060 patients who received screening colonoscopies during the study period, 45% of patients received navigation; the average number of screening colonoscopies per month increased from 75.7 before the intervention to 119.0 after the intervention The percentage of broken appointments for all colonoscopies (i.e., screening and diagnostic) declined from 67.2% in the month the patient navigators were hired to 5.3% in the following month and was sustained
Christie et al. (2008)	RCT	Colonoscopy	Community health center in Boston, Massachusetts Navigators assisted patients with arranging for screening after physician referral for colonoscopy; PN services included assisting with scheduling for direct endoscopic referral, transportation, and rescheduling if needed and providing patient support and education, including for bowel preparation, and reminders Population largely female (75%), Hispanic, low income, uninsured or publicly insured	21	53.8% of navigated patients completed screening colonoscopies compared to 13% of the control group (p = .085) No significant difference in bowel preparation 100% of navigated patients very satisfied with PN services
Myers et al. (2008)	Single- group study	FOBT and colonoscopy	Six primary care practices in Delaware PN services included assistance in determining preferred test type (e.g., FOBT, colonoscopy) and patient education	154	152 patients received navigation and of these, 63 patients (41%) were screened by 6 months (45 with colonoscopy and 18 with FOBT)
Chen et al. (2008)	Cohort	Colonoscopy	Mt. Sinai Hospital, New York City, New York Navigators assisted patients with arranging for screening after physician referral for colonoscopy; PN services included assisting with scheduling colonoscopy and providing patient support and education, including for bowel preparation, and reminders Population largely minority (55% Hispanic and 31% African American)	532	All patients received navigation 353 patients (66%) completed screening colonoscopies and 179 (34%) did not Broken appointment rate decreased from 40% before the navigator program to 9.8% afterward Bowel preparation was inadequate in only 5% of study patients A quarter of patients eligible could not be navigated; barriers included incomplete contact information, language barriers, and lapses in insurance coverage
Percac-Lima et al. (2009)	RCT	FOBT, FS, barium enema, and colonoscopy	Massachusetts General Hospital’s Chelsea Healthcare Center, Boston, Massachusetts PN services included barrier assessment and assisting with determining test type, scheduling colonoscopy, translation, and transportation and providing patient support and education, including for bowel preparation Population was low income, 60% female, 40% Latino, 47% White, 5% Black, and 2% Asian	1,223	Randomized 2:1 control to intervention groups. 27.4% of navigated patients completed CRC screening compared to 11.9% of those in control group (p < .001) Navigators had an average of 3.1 contacts with patients and 39% of patients had in-person meeting with navigator Patient barriers included lack of knowledge, lack of motivation, concerns about procedure, difficulty scheduling appointment, difficulty with bowel preparation, lack of translators, cost, and lack of transportation and escorts
Ma et al. (2009)	Two-group, quasi- experimental design	Test type(s) not specified	Korean Americans recruited from 6 community Korean churches, city not specified Culturally appropriate cancer education program, including navigation; theory based (health belief model and social cognitive theory); PN services included assisting with appointments, translation, paperwork, and transportation and providing patient education and results facilitation; intervention group also received small group education sessions Population composed of Korean immigrants	167	84 in intervention group (3 churches) and 83 in control (3 churches). At 12 months postintervention, screening rates increased from 13.1% to 77.4% among intervention group; whereas increase in control group was from 9.6% to 10.8%. (64.3% increase versus 1.2% increase, significant at p < .001) Based on baseline and postintervention assessments; also observed increases in knowledge, perceived susceptibility, and perceived benefits of screening and decreases in perceived barriers to screening among intervention group
Lasser et al. (2009)	Cohort	FOBT and colonoscopy	Patients of community health center within safety net health system in Somerville, Massachusetts Navigators assisted patients with arranging for screening after physician referral for screening; theory based (stages of change); PN services included assisting with test choice, appointments, and providing patient support and motivation, appointment reminders, and education, including for FOBT cards and bowel preparation Population was approximately 69% female, over 30% non-White	145	55 in intervention group, 90 in control group Patients in intervention group more likely to be screened within 6 months than control (31% vs. 9%, p < .001) On average, 4 hours of telephone navigation provided per intervention patient
Lasser et al. (2011)	RCT	FOBT and colonoscopy	Patients of 4 health centers and 2 public hospital-based clinics in safety net health system in Cambridge, Somerville, and Everett, Massachusetts PN services included assisting with test choice, appointments, getting insurance, and escorts and providing patient support and motivation, education, including for FOBT cards and bowel preparation; navigators also met patients at colonoscopy appointment Population was approximately 60% female, over 50% racial minorities including those speaking English, Haitian Creole, Portuguese, or Spanish	465	Randomized 1:1 control to intervention groups. Patients in intervention group more likely to be screened at 12 months than control (33.6% vs. 20%, p < .001) Within intervention group, those reached by navigator were more likely to screened than those not navigated (39.8% vs. 18.6%, p < .001)
Lebwohl et al. (2011)	Historical comparison	Colonoscopy	Columbia University Medical Center, New York City, New York PN services included assisting with appointments and providing patient education, including bowel preparation, and reminders; navigators also met patients at colonoscopy appointment and follow up with patients to confirm follow-up plan Population was 59% female and 11% White, 24% Black, and 65% Hispanic (demographic data only available for 357 navigated patients)	749	Assessed colonoscopy volume at the Medical Center by comparing total number of completed colonoscopies 12 months preceding the intervention to first 12 months of the intervention Observed 11% overall increase in screening volume between two time periods (5,081 vs. 5,637); among Medicaid outpatients, the observed increase was 56% (957 vs. 1,489) 749 patients were navigated; of these 678 (91%) completed colonoscopy
Paskett et al. (2012)	Group randomized, nested cohort	Colonoscopy	8 primary care clinics and 4 community health centers in Columbus, Ohio; total of 18 clinics Navigators assisted patients needing diagnostic testing after abnormal screening for breast, cervical, or colorectal cancer; theory-based (chronic care model, social support theory, health belief model); PN services included assessing barriers, assisting with appointments, childcare, and transportation and providing patient support, education, and encouragement Population was largely female (97%) and White (71%). 22% were Black	862	Assessed timeliness of diagnostic resolution for breast, cervical, and colorectal cancer screening; included pre- and post-assessments of psychosocial aspects, trust in physicians, anxiety, depression, and perceived social support PN effect was apparent beginning 6 months after detection of abnormality; found that diagnostic resolution rate at 15 months was 65% higher in PN arm (p = .012 for difference in resolution rate across arms; p = .009 for an increase in the HR over time); note that authors did not separate results by cancer type Number of patients receiving diagnostic testing for colorectal cancer was not specified; 97% of study population was female Three commonly reported barriers among those reporting them were test type/treatment misperception/beliefs, communication problems with providers, and scheduling problems
Wells et al. (2012)	Cluster randomized	Colonoscopy	12 primary care clinics in Tampa Bay, Florida Navigators assisted patients needing diagnostic testing after abnormal screening for breast and colorectal cancer; PN services included assessing barriers and assisting patients to overcome those barriers Population was largely female (94%), Hispanic (58%), and uninsured (52%); 16% were referred due to a colorectal cancer abnormality	1,267	Assessed timeliness of diagnostic resolution for breast and colorectal cancer screening 282 patients had colorectal abnormality (either rectal bleeding or abnormal FOBT); 85% of diagnostic tests performed were colonoscopy PN did not affect overall time to completion of diagnosis or the number of patients reaching diagnostic resolution
Raich et al. (2012)	RCT		Denver Health, safety net health system, Denver, Colorado Navigators assisted patients needing diagnostic testing after abnormal screening for breast, prostate, or colorectal cancer; theory-based (chronic care model); PN services included assessing barriers and assisting with appointment setting and providing patient support and education; navigators also met patients at appointments when needed Population was largely minority (53% Hispanic, 19% Black, 24% White), low income, and unemployed	993	Assessed timeliness of diagnostic resolution for breast, prostate, or colorectal cancer screening 235 patients had colorectal abnormality (rectal bleeding, abnormal FOBT, or sigmoidoscopy) PN shortened time for colorectal (p = .0017); patients navigation for colorectal cancer were more likely to reach diagnosis than those in control group (79% vs. 58%, p < .002)
Myers et al. (2013)	RCT	Fecal blood tests and colonoscopy	10 primary care practices of the Christiana Care Health System in Delaware Patients randomized to TNI, SI, or usual care; screening decision stage was assessed for colonoscopy and FOBT; tailored navigation group received mailed instructions for preferred test (and test kit if FOBT), 1 phone call by navigator to address concerns and encourage testing, and a mailed reminder; Standard group received materials by mail, including FOBT and instructions for colonoscopy; study also assessed changes in screening decision stage based on precaution adoption process model and assessed behavioral predictors associated with the preventive health model Population was largely White, non-Hispanic, and 50–59 years	945	Colorectal cancer screening adherence was greater for both the TNI (38%) and SI (33%) groups than control group (12%; p = .001 and p = .001, respectively); however, there was no statistically significant difference between the TNI and SI groups Statistically significant increases in the screening decision stage were experienced by patients in the TNI (+45%) and SI (+37%) groups than in the control group (+23%; p = .001 and p = .001, respectively)

NOTE: RCT = randomized control trial; FOBT = fecal occult blood test; FS = flexible sigmoidoscopy; PN = patient navigation; TNI = tailored navigation intervention; SI = standard intervention.