Patient Navigation in Breast Cancer: A Systematic Review

Stephanie Robinson-White, MD; Brenna Conroy, BS; Kathleen H. Slavish, BA; Margaret Rosenzweig, PhD, APN-BC, AOCNP

Cancer Nurs. 2010;33(2):127-140.

Discussion

Study Design

Clearly, the review of navigation efficacy indicates a positive trend toward adherence to breast cancer screening, follow-up of diagnostic abnormalities, initiation of breast cancer treatment, and stability or improvement in quality of life with patient navigation in breast cancer. These results are encouraging, yet there is still a great deal to pursue in the research agenda. Research design overall is still not appropriately rigorous. Only 3 of the 12 studies were a randomized, controlled design.^[40–42] Regardless of design, power analysis was not included in any reporting.

Navigation influence can be heavily personally influenced through the strength of an engaging personality. All of the interventions required individuals to deliver the intervention. The interpersonal or "indirect" effect on the interpersonal relationship needs to be separated from the navigation intervention to understand the effects of the individual components of the navigation intervention. The individual navigator's personality and warmth may be an important, integral component of the navigation's success, but it is important to discern if the relationship between the navigator and patient is a direct, quantifiable effect (and measurement tools used to quantify) or an indirect effect of the intervention. These delineations are important for analysis and for dissemination into routine clinical practice.

In addition, few reviews detailed or evaluated the role of navigation through breast cancer treatment, including surgery, chemotherapy, and radiation therapy, and/or long-term hormonal therapy. In addition, all studies concentrated on nonmetastatic breast cancer. Concentrating all navigation research in early-stage, predominantly diagnostic settings does not address the potential navigation needs of women with more advanced-stage illness, women receiving chronic breast-cancer therapy, or women reluctant to finish initial treatment.

Study Setting

Although heterogeneous in location, each of the studies had settings that provided accessible and affordable breast cancer screening and follow-up support to women in predominantly minority, urban, and socioeconomically disadvantaged areas. Each particular study and setting had a unique goal with respect to navigational intervention for women undergoing breast cancer screening. Despite different goals and settings, independent results of each study illustrate similar outcomes. The most compelling is the documented or potential value of accessible, affordable, and supportive breast navigation services across breast cancer settings. These studies were conducted in predominantly minority and economically underserved areas, many in urban cancer centers (10/12 studies), and may be an important intervention toward reducing breast cancer outcome disparity for underserved populations. Interventions using navigation for optimal breast cancer outcomes should be extended to rural settings.

Intervention/Navigation Role The role of the patient navigator in these studies (Table 2), although heterogeneous, always involved coordination or encouragement toward further care. The roles varied in the scope and the attention toward an emotional or quality-of-life component. More information is desired. The extent of the protocol of the navigator role was not well described in any study. For example, we do not know of a script or an algorithm of response in the encouragement components of the interventions. These data could be helpful for further analysis or replication of the navigator role. The navigator characteristics were not always addressed.^{[32,34,36,38]} Despite literature supporting the importance of survivors and race-matched interventionists,^[2–4] navigators seemed to be effective without meeting all traditional criteria (member of the community they intend to serve and cancer survivor).^[2] None of the studies specifically identified the navigators as being race matched. Two studies^[35,37] used breast cancer survivors in a navigator role. When described, most navigation roles were nonhealthcare professionals educated for a primarily supportive, co-coordinating role.^[39–41] Importantly, the cost of the navigation role/patient benefit was not discussed. The lack of attention to the cost of navigation will limit its clinical usefulness.

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Table 1. Patient Navigator Research Program (PNRP): Eliminating Barriers to Timely Delivery of Cancer Diagnosis and Treatment Services
Study	Location/Affiliation	Patient Population	Navigator Characteristics	Specific Aims
The patient navigation in the SafetyNet: CONNECTeDD Project	Boston University Medical Center, Boston, MA	Racial/ethnic minorities and low-income women with breast or cervical cancer	Race matched	''To improve access to and increase cancer screening, early-stage detection, diagnosis, and treatment by creating an intervention that: (a) reduces time to diagnosis or for resolution of an abnormality after an abnormal mammogram or Pap smear [Papanicolaou test]; (b) reduces time to complete treatment and provides higher-quality treatment after a cancer diagnosis; (c) improves patient satisfaction with healthcare services; (d) comprises critical components (ie, time with patient vs time coordinating care) that drive its success; and (e) results in more cost-effective care.''
The Improving Patient Outcomes Through System Navigation Project	Denver Health and Hospital Authority, Denver, CO	Minority and underserved patients in the Rocky Mountain region with breast colorectal and prostate cancers	Lay community health workers	''(a) Reduce the time between an abnormal screening test for breast, colorectal, and prostate cancers to a positive or negative pathological diagnosis; (b) Reduce the time from a positive pathological diagnosis of breast, colorectal, or prostate cancers to the start of therapy; (c) Increase the proportion of patients adhering to recommendations for care, including completion of additional diagnostic tests, consultation appointments, and completion of treatment; (d) Improve patient-reported outcomes of medical self-efficacy, satisfaction with care, and distress related to cancer diagnosis; and (e) examine the cost-effectiveness of patient navigation.''
The DC City-wide Patient Navigation Research project	George Washington University, Washington, DC	African American and Hispanic/Latina women with breast cancer	Mixed: 1 nurse practitioner and 6 laypersons with college degrees One of the 7 is a breast cancer survivor	''...To evaluate the efficacy and cost-effectiveness of the 2 navigation techniques and assess the outcomes of the intervention (eg, patient coping styles, communication with providers, and fatalism).''
The Moffitt Cancer Center Patient Navigator Project	H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL	Hispanic/Latina, African American, and migrant farm workers with breast or colorectal cancer		''...This study aims to conduct a comprehensive intervention and evaluation of patient navigation on quality of cancer care, patient satisfaction and quality of life, and cost-effectiveness.''
The Northwest Tribal Cancer Navigation Project	Northwest Portland area, Indian Health Board, Portland, OR	Native Americans and Alaska Native patients with breast, cervical, prostate, and colorectal cancer	A nurse navigator and community navigator, paired as a team	''...The project's primary goals include (1) reducing the proportion of late-stage cancers diagnosed among tribal people; (2) improving the continuity of healthcare for cancer patients; (3) reducing cancer-related morbidity; (4) improving the quality of life and well-being of navigated cancer patients; and (5) determining whether the program is a cost-effective approach to reducing cancer health disparities among American Indians and Alaska Natives.''
The Chicago Cancer Navigation Project	Northwestern University, Evanston, IL	Low-income patients with prostate, colorectal, breast, or cervix abnormalities	Patient navigation team consisting of a nurse, social worker, and lay navigator	''...to provide a patient navigation intervention that will (1) increase the proportion of patients with diagnostic evaluations at intervention sites in comparison with usual care at control sites and past performance; (2) improve mean time to diagnostic resolution between abnormal screening and definitive follow-up; (3) significantly shorten the time to initiation of treatment following confirmatory diagnosis; (4) evaluate cost-effectiveness; (5) identify psychosocial and demographic factors associated with navigation noncompliance; and (6) assess patient satisfaction with the navigation experience.''
The Randomized Control Trial of Primary Care–Based Patient Navigation-Activation Project	University of Rochester, Rochester, NY	Racial/ethnic minorities and low-income populations with breast or colorectal cancer	Laypersons with a mandatory high school education; most have prior experience in human services or community outreach	''To evaluate the impact and level of intensity (ie, low, moderate, and high) of patient navigation on cancer-related quality of care, disparities in cancer-related care, and costs.''
The Texas Health Science Center's Patient Navigation Research Project	University of Texas Health Science Center, San Antonio, TX	Hispanic/Latina and African American women with breast and cervical cancer, including cervical dysplasia	Social work background and the other will have a nursing (RN) background	''...will address questions concerning cost-effectiveness, timeliness of care, impact of navigation on patient satisfaction, cancer outcomes, and the general health of the population.''
The Ohio Patient Navigation Research Program (OPNRP)	The Ohio State University	Underserved patients with colorectal, breast, and cervical cancer		''OPNRP aims to (1) review baseline rates, barriers, and strategies to overcome barriers to receiving timely diagnostic and treatment services; (2) partner with a consortium of institutions in Ohio, including the Ohio State University Comprehensive Cancer Center and James Cancer Hospital, Case Western Reserve Comprehensive Cancer Center, University of Cincinnati Cancer Center, respective primary care networks, and community partners; (3) implement and evaluate the patient navigator program in 36 clinics/health centers using a randomized group; (4) conduct a process evaluation to assess the barriers to the implementation of the intervention program; (5) conduct a cost-effectiveness evaluation of the program; and (6) assess the impact of the program on community-level indicators.''

Table 2. Patient Navigation Interventions
Title	Author/Year	Setting	Intervention	Design	Goal	Sample Size/Racial Characteristics	Results	Conclusion	Limits
Breast cancer screening in underserved women in the Bronx	Frelix et al^[32](1999)	Mobile van unit and hospital-based mammographic x-ray unit with follow-up provided at urban medical center	Navigator characteristics: bilingual, bicultural Intervention: coordinated follow-up for abnormal screening	Comparative, historic control of newly diagnosed breast cancer cases vs cases found with intervention Power analysis not reported	Increased follow-up visits from abnormal radiographic screening	N = 1,935 (100%) White = 782 (40.4%) Black = 404 (20.9%) Hispanic = 654 (33.8%)	12.9 New cases/1,000 screened vs 6 new cases/1,000 (New York State) and 5.1 new cases/1,000 (nationally) Statistical significance not reported	Community outreach and patient navigation resulted in increased numbers of breast cancer cases diagnosed as compared with state and national incidence	No control group
Abnormal mammogram follow up: a pilot study in women with low income	Ell et al^[33](2002)	Large public and private urban screening, diagnostic and treatment-referral centers for low-income women in Los Angeles and New York City	Navigator characteristics: Team of peer counselor and master's degree–prepared social workers Intervention: tailored health education, counseling, and system navigation provided	Comparative intervention; those enrolled in study vs those not enrolled or those not located or refused study Power analysis not reported	Reduce barriers to breast cancer care and increase adherence to diagnostic follow-up and initiation of treatment	N = 605 Hispanic = 427 (71%) Black = 109 (18%) Other = 68 (11%)	Comparison of enrolled subjects to nonenrollees and subjects lost to follow-up 93% vs 72% adherence to diagnostic follow-up Initiation of treatment 90% vs 69% adherence to follow-up from abnormal screen and initiation of cancer treatment, respectively	Intervention addressing known barriers to cancer diagnosis and treatment initiation was successful for improving adherence to both	Pilot Nonrandomized controlled design
Impact of cancer screening program on breast cancer stage at diagnosis in a medically underserved urban community	Oluwole et al^[34](2003)	Cancer Control Center of Harlem	Navigator characteristics: not addressed Intervention: patient navigator served as a ''proactive patient representative''	Retrospective study of breast cancer patients diagnosed at late stage (stage 3 or 4) before and after patient navigator intervention was implemented Preintervention: 437 women from 1964–1986 registry Postintervention: 305 women from 1995–2000 registry Power analysis not reported	Increase early detection of breast cancer	N = 305 African American = 212 (70%) Hispanic = 81 (26%)	Historical control: 49% late stage (3 and 4) disease at presentation; current cohort: 21% late-stage disease, (P < .001)	Patient navigators can be used to improve early-stage breast cancer detection	Nonrandomized design; compared with historical control
Patient navigation: improving timeliness in the diagnosis of breast abnormalities	Psooy et al^[35](2004)	Nova Scotia, Canadian Breast Cancer Diagnostic Imaging Center	Navigator characteristics: healthcare worker and breast cancer survivor Intervention: assisted referring physician with scheduling biopsy for abnormal breast radiology Shared survivor experiences with patient	Quasi-experimental Compared navigated group to nonnavigated patients Cohort: 536 women in total n = 144 nonnavigated n = 392 navigated Power analysis not reported	Decrease wait time for biopsy and decrease time between abnormal radiographic screening procedure and core biopsy	N = 536 Race/ethnicity not described	Navigated patient mean wait time: for biopsy 14 d Nonnavigated patient mean wait time: 20 d P < .001	Patient navigators improved timeliness in diagnosis of breast abnormalities; P < 0.05	Nonrandomized design; compared with historical control Clinical significance of 6 days less time for biopsy is not established
Navigator program for breast cancer trial recruitment and enrollment at a county hospital	Donnell et al^[36](2005)	Breast Clinic at Parkland Hospital in Dallas	Navigator characteristics: not addressed Intervention: patient navigator used to identify eligible candidates for clinical trials	No. of eligible candidates, no. of patients enrolled, and reasons for not enrolling were recorded N = 373, patients were screened Power analysis not reported	Increase minority and underserved population representation in clinical trials	N = 373 Black = 45.6% Hispanic = 27.6% White = 20.1%	11.3% of eligible patients were enrolled in clinical trials after the navigator intervention Statistical significance not reported	Patient navigators can result in early identification of clinical trial candidates and increase representation of minority and underserved populations in clinical trials	No comparison group
The effect of peer counseling on quality of life following diagnosis of breast cancer: an observational study	Giese-Davis et al^[37](2006)	Santa Cruz, CA	Navigator characteristics: breast cancer survivors matched to ''sojourner'' or woman with breast cancer; training program described Intervention: 6-month peer-counseling intervention	Pretest and posttest design N = 29 women with breast cancer navigated Power analysis not reported	Maintain quality of life in first year following breast cancer diagnosis	N = 29 White = 86.2% Asian American = 3.4% Mexican American = 3.4% Other Hispanic = 3.4% Other = 3.4%	PCL-C; P < .001 FACT-B, emotional; P = .003 CES-D, nonsignificant	Patient navigators can improve quality-of-life outcomes	Small sample Nonrandomized design
Patient navigation in breast health services: improving quality of services at a safety net hospital in Chicago	Allgood et al^[38](2007)	Mount Sinai Hospital in Chicago	Navigator characteristics: not specified Intervention: patient navigators provide assistance with transportation, referrals, translation, and providing emotional support	Comparative historic control, comparing loss to follow-up after abnormal breast screenings before and after navigator implementation Power analysis not reported	Decrease loss to follow-up rate after abnormal breast screening		Preintervention: loss to follow-up rate was 33% Postintervention: rate was 15% (P < .001) Among those returning for additional imaging resulting in mammograms highly suggestive of an abnormality, the loss to follow-up rate was reduced from 50% in 2005 to 0% in 2006. (P < .01)	The use of a patient navigator in breast health is an effective way to reduce the loss to follow-up following a finding suggestive of breast cancer from screening examination	No randomized controlled design, navigator characteristics unknown
Improving follow-up to abnormal breast cancer screening in an urban population	Battaglia et al^[39](2007)	Urban academic hospital–based diagnostic breast center in Boston	Navigator characteristics: experience caring for a diverse population and knowledge of local health systems, case manager Intervention: coordinated care for each patient	Preintervention/postintervention study Preintervention (historic control): N = 314 Postintervention (current cohort): N = 1,018 Power analysis not reported.	Improve timely follow-up to abnormal screening Timely defined as <120 d from date of initial referral to first visit	N = 1018 White = 373 Black = 391 (40%) Hispanic = 146	Preintervention: 64% had timely follow-up Postintervention: 78% had timely follow-up (P = < .001) Navigated patients had 39% greater odds of timely follow-up	Patient navigation improved rates of timely diagnostic follow-up for abnormal breast cancer screening	Nonrandomized design; preintervention/post intervention design
Patient navigation and case management following an abnormal mammography: a randomized clinical trial	Ell et al^[40](2006)	Public medical center serving low-income women in Los Angeles	Navigator characteristics: bilingual, training module is accessible Intervention: The SAFe Model intervention navigator performed telephone-based risk assessment, including health education, referral to MSW for psychosocial counseling	Randomized controlled trial comparing usual care to intervention N = 204 96 Subjects randomized to intervention and 108 subjects randomized to usual care	Improve the rate of follow-up through diagnostic resolution within 8 mo by using the Screening Adherence Follow-up program	N = 204 Predominantly Hispanic	Navigated patients were more likely to adhere to diagnostic follow-up through resolution than usual-care patients (90% vs 66%); P < .001 and were more likely to adhere than usual care (non participants) P = 0.01.	Patient navigation and counseling were effective in improving diagnostic resolution follow-up among low-income women with abnormalities found in mammograms	Power analysis not reported
Increasing utilization of cancer genetic counseling services using a patient navigator mode	Rahm et al^[41](2007)	Kaiser Permanente of Colorado and the University of Colorado Hereditary Cancer Clinic	Navigator characteristics: research assistant without specialized genetic education, trained as patient navigator Intervention: aided by scripts and physician backup, navigator made telephone contact with patients to explain referral, clarify content of counseling session, schedule appointments, and send reminders	Randomized controlled trial comparing usual care to intervention N = 125 55 Randomized to patient navigator and 70 randomized to usual care No power analysis reported	Increase utilization of cancer genetic counseling	N = 125 Race/ethnicity not addressed	More members in the patient navigator arm attended genetic counseling than in the usual-care arm (44% vs 31%), results were not statistically significant Navigator use decreased time to appointment with the genetics counselor; 83% of the navigated group who made an appointment made it within 3 mo, while 32% of those in UC made it within that time (P = .002)	Navigators shortened time from referral to appointment for genetic counseling and may increase utilization of services	3-mo pilot of small sample size with limited power to detect statistical significance
The effect of patient navigation on time to diagnosis, anxiety, and satisfaction in urban minority women with abnormal mammograms: a randomized controlled trial	Ferrante et al^[42](2007)	Public urban university hospital in Newark, NJ, that serves a predominantly low-income minority population	Navigator characteristics: bachelor's degree in a social science or related field, at least 2 y of clinical, social work, or outreach experience and knowledge of the community and existing health resources Intervention: navigator provided the patients with emotional and social support, helped patients make appointments and arrive to scheduled appointments, prepared and on time, facilitated applications for financial assistance, connected patients with resources and support systems, and facilitated interaction and communication with healthcare staff providers	Randomized controlled trial comparing usual care to intervention N = 105 50 Randomized to usual care and 55 randomized to patient navigator Power analysis not reported	Improve timeliness to diagnosis, decrease anxiety, and increase satisfaction in urban minority women after an abnormality is seen in mammogram	N = 105 (100%) Black = 59% Hispanic = 27.6% Other = 13.3%	Intervention group had shorter diagnostic intervals than women in control group	Patient navigation is an effective strategy to improve timely diagnostic resolution, significantly decrease anxiety, and increase patient satisfaction among urban minority women with abnormalities found in mammograms	Excluded a high number of the study population who did not speak English Enrollment rate of 36% of eligible patients participating
Effects of an outreach and internal navigation program on breast cancer diagnosis in an urban cancer center with a large African American population	Gabram et al^[43](2008)	Urban healthcare setting: AVON Comprehensive Breast Center at Grady Memorial Hospital in Atlanta, GA	Navigator characteristics: completed Community Health Advocate and patient navigator training program Intervention: navigators communicated directly with community members to encourage screening, diagnostic procedures, and treatment	Cross-sectional study examining disease stage at diagnosis during the years of early implementation (2001) and the follow-up (2004) of community outreach and internal navigation programs Power analysis not reported	Raise breast cancer awareness, increase mammography screening rates, and enhance the process of receiving prevention and treatment services	N = 487 (100%) African American = 89% White = 5% Hispanic = 2% Other = 4%	In the interval from 2001 through 2004, the proportion of stage 0 (in situ) breast cancers increased from 12.4% (n = 14) to 25.8% (n = 33; P < .005), and there was a decline in stage IV invasive breast cancers from 16.8% (n = 19) to 9.4% (n = 12; P < .05)	Outreach initiatives and internal patient navigation appear to have improved stage at diagnosis	Nonrandomized controlled design No establishment of a causal relation between the community education, outreach initiatives, and the effect on stage migration in this largely African American population.

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