Lay patient navigator program implementation ... - Wiley Online Library

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Lay Patient Navigator Program Implementation for Equal Access to Cancer Care and Clinical Trials Essential Steps and Initial Challenges

Michael L. Steinberg, MD1 Allen Fremont, MD, PhD2 David C. Khan, MD1 David Huang, MD1 Herschel Knapp, PhD1 Deborah Karaman, MPH1 Nell Forge, PhD2 Keith Andre, MA1 Lisa M. Chaiken, MD1 Oscar E. Streeter, Jr., MD3

BACKROUND. Disparities in cancer detection, treatment, and outcomes among racial/ethnic minorities and low-income patients are well documented. One way to reduce these disparities is to use patient navigators to address barriers to care. However, little information about optimal characteristics of navigator programs or considerations for those interested in setting up such programs is available.

METHODS. The design and implementation of a patient navigator program for underserved cancer patients in an urban, nonacademic community hospital setting is described. The program, which used lay navigators, was conceived as a component of the Urban Latino African American Cancer (ULAAC) Disparities Project in South Los Angeles, a National Cancer Institute (NCI)-sponsored project to improve cancer care and clinical trial access for minority and low-income patients.

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RESULTS. Careful initial planning, including input from a community advisory com-

Radiation Oncology, Centinela Freeman Regional Medical Center, Inglewood, California.

mittee, was essential to smooth program implementation. Thirty-one volunteers com-

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pleted navigator training in the program’s first year of operation. Of 135 patients

Rand Corporation, xxx, California.

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University of Southern California—Norris Cancer Center, Los Angeles, California.

offered navigation services, 75 (56%) accepted, and preliminary feedback from patients, navigators, and providers suggests high levels of satisfaction with navigation. Standardized templates used by navigators and staff to record key information are proving helpful for monitoring quality and outcomes (such as effectiveness in addressing specific barriers to care) and continually improving the program.

CONCLUSIONS. The ULAAC program represents a viable model for developing lay navigator programs in community hospitals. Preliminary assessments suggest that the program has a positive effect on minority and low-income cancer patients’ experience with care and reduces barriers to care. Additional time and research are needed, however, to fully assess the impact on care and outcomes. Cancer 2006; 107:2669–77. 2006 American Cancer Society.

KEYWORDS: lay navigator program, minority, low-income, cancer detection.

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Supported by a Cancer Disparities Research Partnership (CDRP) grant (to O.S.). Address for reprints: David C. Khan, MD, Radiation Oncology, Centinela Freeman Regional Medical Center, 333 N. Prairie, Inglewood, CA 90301; Fax: (310) 419-8317; E-mail: [email protected] Received June 6, 2006; revision received August 14, 2006; accepted September 18, 2006.

ª 2006 American Cancer Society

ignificant disparities in cancer detection, treatment, and outcomes among racial/ethnic minorities and low-income patients persist despite widespread documentation and substantial public and private investment.1–5 Furthermore, as medical knowledge and technologies advance, the gap in healthcare delivery for these patient groups may increase for certain emerging state-of-the-art treatments.6–7 Additionally, these patient groups are generally underrepresented in clinical trials, which are vital to establishing new-treatment effectiveness in these vulnerable patient subgroups.8 The causes of the disparities are complex, but most experts agree that financial and nonfinancial barriers to appropriate and timely care play a critical role.1–11 Barriers common to virtually all cancer patients—eg, competing demands of work, family responsibilities,

DOI 10.1002/cncr.22319 Published online 31 October 2006 in Wiley InterScience (www.interscience.wiley.com).

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December 1, 2006 / Volume 107 / Number 11

and emotional stress—may be particularly pronounced for minority and low-income patients, whose access to transportation or ability to afford childcare while going through treatment may be limited. Also, various barriers unique to certain subgroups, such as culturally specific health beliefs that generate distrust of the healthcare system and clinical research trials, can make obtaining and completing optimal care more complex.12–14 One approach to reducing barriers to care is to use patient navigators as personal advocates facilitating patients’ movement through the standard care process or aiding patients in completing appropriate clinical trials.15 The patient-navigator concept and corresponding literature are still relatively new, and concept definitions and implementations vary widely across settings and investigators.16–17 Navigator models range from full-time salaried professional case managers to lay volunteers from the community; navigator programs range from being tightly integrated into the overall oncology care system to being peripheral to medical treatment and having little interaction with oncology staff. Studies are under way to assess which models and which aspects of patient navigator programs are most useful and cost-effective18 in different settings, but providers have little to guide them as to a patient navigator program’s validity for their practice setting, what type of program should be implemented, and what steps are required to establish a program. To help fill this gap, this case study describes basic steps and practical considerations for establishing a lay patient navigator program in a community hospital serving a predominantly minority and low-income population.

MATERIALS AND METHODS The patient navigator program we describe is part of a larger project, the Urban Latino African American Cancer (ULAAC) Disparities Project based at the Centinela-Freeman Regional Medical Center (CFRMC). CFRMC is a community hospital system serving predominantly minority and low-income residents in south central and southwest Los Angeles, California. The area’s population is 1.2 million, including 38% African Americans and 54% Latinos; median income is approximately $33,000.19 The ULAAC program was established in 2003 with support from the National Cancer Institute (NCI). CFRMC and its ULAAC project are 1 of 6 sites chosen for the NCI Cancer Disparities Research Partnership (CDRP) program, which aims to reduce disparities in quality of care and outcomes by developing infrastructure needed to support research and clinical trials

within community hospitals serving significant minority communities.20 CDRP funding is primarily for setting up technical infrastructure and systems to run clinical trials; however, the NCI allowed us to use part of the funding to support our development of a patient navigator program to help address minority and lowincome cancer patients’ barriers to standard care and clinical trial participation. The cost of the program yearly is approximately $400,000 with an additional 42% for indirect institutional expenses related to the program. This amount includes the cost of placement, maintenance, and support of the clinical trails program and a robust telemedicine system called Telesynergy that links our hospital with our mentor institutions. We begin by describing our steps in designing the navigator program and developing the basic infrastructure to support it; we then discuss navigator recruitment and training, results from the program’s first year of operation, and lessons learned thus far and next steps. Our discussions draw on multiple sources of data: direct observation, interviews, focus groups, questionnaires, and navigator- and staff-completed forms about patient encounters. Because the numbers of navigators, patients, and providers are relatively small, we limit details about participants’ characteristics to protect confidentiality.

Initial Planning and Design With basic support for and commitment to addressing disparities in place, the ULAAC program’s initial step was to determine what sort of patient navigator program to develop. Forms of programs, navigators’ roles and responsibilities, and qualifications set for navigators—all of these vary widely. Thus, whereas a literature review and discussions with leadership of existing navigator programs were helpful, no established model adequately fit our setting’s particular needs and realities. CFRMC has case managers and clinical social workers, but they generally lacked adequate time to work with individual patients at the level and with the content we envisioned for navigators. One route we assessed and abandoned was to increase these professionals’ available time or to hire additional professionals to serve as navigators. We concluded that the costs would exceed available funds, making program sustainment less likely once NCI funding ran out. We also felt that professionally trained navigators might not differ enough from current sources of minoritypatient support to justify the added expense. The use of lay navigators was appealing for several reasons. Lay navigators, particularly those who have survived cancer, can relate to patients and identify subtle barriers in ways that busy health professionals often cannot. Also, drawing lay navigators from the

Lay Patient Navigator Program/Steinberg et al.

surrounding community was consistent with the sort of community partnerships CFRMC and the NCI sought. The cost of part-time lay navigators at the small hourly stipend we decided to pay—even for a large group (say, 12–14)—was considerably lower than the cost of several full-time professionals. And we wanted the group to be relatively large to facilitate 1 of our priorities: that each navigator spend as much time as needed to support any given patient. Furthermore, given the more than 20 languages spoken in our service area and the known cultural differences within minority subgroups (for Latinos: Mexican, Central American, South American), we saw a diverse navigator base as essential for effectively identifying and addressing barriers to care for all patients.

Staffing To ensure that the navigator program moved from concept to reality, we had to designate and hire staff. Two essential operational positions to be filled early were community health educator (CHE) and program administrative assistant (AA). The CHE’s primary role is to recruit, select, train, and supervise navigators. However, this person’s experience working with cancer patients in the community and other stakeholders proved invaluable to the program’s physician leader (PL) during program planning and development. A dedicated AA was equally necessary, in this case for coordination of meetings during the design and implementation process. Once the program was operational, the AA’s role also encompassed coordinating the administrative function of navigator training, patient/ navigator assignments, and ULAAC recordkeeping. A third important staff position was senior patient navigator (SPN), an initially informal role that grew formal with time. The cancer survivor who created and filled this position, and who had served many years as a volunteer lay navigator in a nearby minority community, helped immensely in developing and implementing the training curriculum and, once navigation began, in supporting and supervising navigators. Other key staff members are a medical social worker (MSW) and an oncology nurse (ON), who act as liaisons between the navigator program and the professional case-management staff, and collaborate with the CHE in overseeing patient and navigator interpersonal and community access needs and coordinating data collection and reporting. Also, because a core program component is to facilitate clinical trials, a clinical research coordinator (CRC) serves as a resource for all program staff and physicians, supplying instruction, support, and materials related to clinical trials. The CRC and all other team members

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collaboratively track the program’s quality function, under the oversight of the PL.

Community Input A crucial aspect of the navigator program’s implementation and subsequent functioning was the involvement of a community advisory board (CAB) and a community-based medical advisory board (MAB). The CAB, comprising nonmedical health activists and volunteers, serves as ULAAC’s community sounding board. This group provides valuable information, including insights on patient needs and communitybased barriers to care, evaluation of ULAAC functions, and perspectives on clinical trial acceptance. The MAB comprises local primary care, surgical, and oncology subspecialists with strong community affiliation. They advise on aspects of the program’s community implementation and function as counsel for clinical trial issues related to community applicability and need. Defining Roles and Functions of Patient Navigators Barriers to care in south central and southwestern Los Angeles may be numerous and seem insurmountable to patients with cancer, a disease requiring complex treatment management and coordination of care from multiple specialties. We envisioned navigators as specially trained community-based healthcare advocates capable of guiding the cancer patient through the healthcare system. In defining their roles, we emphasized assistance to patients with the communication, transportation, financial, administrative, and emotional barriers to receiving care. Navigators are expected to work closely with ULAAC professional staff and to interact with medical and community service providers to help ensure good coordination of care and effective use of community resources. In addition to performing the basic navigation functions, navigators are trained and expected to address the possibility of patient participation in clinical trials when appropriate and to support patients whether they decline or elect to participate. This second role is consistent with the larger goals of the ULAAC project (and the CDRP program) to offer stateof-the-art standard treatment, patient navigation, and availability of clinical trials for patients within their community. Navigators are also expected to help document patient interactions and interventions to track navigation’s effectiveness and outcomes. Figure 1 defines specific activities. Program Operation and Procedures Because lay navigators are to interact directly with patients and be part of the healthcare team, guidelines

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FIGURE 1. ULAAC Disparities Project Patient Navigator Role Description.

and operating procedures are important. Navigators need a set of clear expectations about what their role is and is not. Physician providers who will interact and, ideally, work with navigators to ensure patient care proceeds smoothly need to be educated. Working out some of the basic logistics and procedures before recruiting and training navigators was essential in ensuring that potential navigators realistically understand what being a navigator entails. We describe the basic policies and procedures and the quality assurance mechanisms next.

Recruiting and Training Lay Navigators Once the basic navigator functions and program policies were defined, training dates were set. The CHE e-mailed 15 community health programs and health activists, including local cancer support groups, cancer advocacy organizations, and CAB members. The communication described the navigator program and navigator job and mentioned the associated, modest monetary stipend. Those contacted were requested to disseminate the details of the navigator training opportunity through their community networks.

Recruitment Potential navigators were screened over the phone and then invited to a 1-hour orientation during which ULAAC staff described the project, the navigator’s role, and the logistical aspects of being a navigator. Potential trainees were then asked to consider what they had heard and, if interested, to call the ULAAC office to register for the 6-hour training course. The initial telephone screening process was effective in eliminating potentially poor candidates. Some telephone respondents were looking for full-time work, which did not match our expectation of typically 2–6 hours per week. As an incentive for quality work, professionalism, and retention, we had decided during the planning process to offer a small stipend rather than use volunteers. The recruitment process was designed to have built-in ‘escape routes’ for prospective lay navigators who changed their mind. Choosing not to attend the orientation or the training, or to not start accepting patient assignments after training—these are all avenues of departure for a potential navigator.


Navigator Training Our navigator training comprised an intensive 6-hour introductory course, plus ongoing mentoring by the CHE and SPN, and didactic sessions in conjunction with bimonthly navigator meetings. Because we wanted to attract a diverse group of navigators and did not want to discourage those who work full or part time or have childcare responsibilities, we divided the initial training course into 2-hour sessions over 3 days rather than conducting it in 1 long session. The course is a comprehensive, interactive program covering the navigator’s role; communication with patients, with active listening; cancer care education; access to community resources; ethics and privacy practices, including the Health Insurance Portability and Accountability Act (HIPAA); professional boundaries; the importance of clinical trials; an introduction to current ULAAC clinical trials; and the patient navigation process. The ULAAC program goals and structure are introduced on the first day. The navigator’s role is developed by examining the community’s existing barriers to healthcare. We use an interactive teaching model in which trainees are asked to list obstacles to care that they have encountered and discuss ways to overcome these obstacles. Vignettes of typical patient situations are examined to determine how a navigator might assist. On the second day, the navigator/patient relationship is discussed, including initiating contact, offering services, and empowering the patient. Recordkeeping is demonstrated in detail, emphasizing the importance of adequate charting. Also provided is an introduction to the biology of cancer and common types of cancer treatment, along with an overview of clinical trials, presented by a physician, that includes information on the patient benefits of trial participation. Day 3 begins with a presentation on the emotional challenges for cancer patients aimed at sensitizing trainees to fears and uncertainties cancer patients may face. Facilitative communication skills, such as building rapport and active listening, are demonstrated and reinforced with role-playing exercises. Barriers to clinical trial participation are discussed from the trainees’ viewpoints; this discussion then becomes the starting point for reviewing patient protection and informed consent. Benefits of clinical trial enrollment are reaffirmed as the trainees learn how to appropriately speak to patients about clinical trial participation. The training ends with presentations on patient confidentiality and HIPAA. Throughout this introductory course, participants are reassured that it is only the beginning of an ongoing training process. Once the navigators complete training and are working with patients, they

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receive guidance and support from the CHE and SPN as needed. Additionally, they participate in 2-hour bimonthly sessions called support groups, each of which features a speaker on a topic chosen to enhance navigator knowledge and provides structured time for discussing cases and navigation logistics. Besides providing continuing education, these groups offer navigators support and networking opportunities.

Linking Navigators With Patients and the Navigation Process Patients are first offered a navigator during initial consultation in the oncology departments. This is also when they are assessed for eligibility for available clinical trials by the physician, CRC, and ON. Assigning Navigators A navigator is assigned to a particular patient only after 1 of the ULAAC staff (CHE, ON, or AA) completes an initial patient intake process to assess whether the patient’s needs are amenable to navigation. This step occurs within 24 hours of notification by the oncology departments. Patients decide whether to accept or decline the offer of a navigator depending on their perceptions of their personal circumstances, their needs, and their feelings about the navigator service concept. Patients who initially decline navigator services are given the option of having ULAAC staff follow-up with them by phone or during 1 of their treatment sessions to see whether they have changed their mind. All patients who opt for the navigation program may continue to have a navigator whether or not they meet clinical trial criteria or accept or decline an offered clinical trial. A patient’s needs are matched with an individual navigator’s skills and experience to make the navigator assignment, a task the CHE generally performs, sometimes with input from the SPN or other staff. Whenever possible, navigators are culturally and linguistically matched to patients to facilitate development of a supportive relationship that can be maintained throughout the patient’s treatment course. Examples of criteria for matching patients with navigators are language, racial/ ethnic background, navigator’s experience with patient’s type of cancer and navigation in general, navigator’s personality and interpersonal style, and navigator’s proximity to both the patient and the ULAAC program. Navigator caseload is also considered; caseloads vary (1–8 cases per navigator) depending on time availability and assigned patient needs. Navigation Process Once a navigator is assigned to a patient and the two meet, the navigator assumes responsibility for identi-

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fying and reporting any trouble the patient is having making his/her way through the system. Barriers to care are determined and documented. Navigators are required to document all patient encounters using the SOAP (Subjective, Objective, Assessment, Plan) format most health providers use when writing progress notes. All encounters are reviewed by ULAAC staff. Navigators report directly and regularly to ULAAC personnel (CHE, SPN, AA). Through the ongoing reporting process, the navigation program provides important real-time feedback that is shared with the ULAAC program staff and patients’ physicians to enhance care coordination. Therefore, navigators are responsible for monitoring the patient flow through the system and identifying barriers to that flow. The coupling of the navigator’s observations of the patient’s problems with the navigator’s community, cultural, and life experience (many of our navigators are cancer survivors) gives the navigator valuable insight into the care process for patients. Navigators become the eyes and ears for the patient’s interaction with healthcare system. When the navigator identifies individual or systematic problems that cannot be readily addressed, the CHE ensures that appropriate remedies are implemented.

Navigator Role in Accrual and Retention of Clinical Trial Participants An important goal of the ULAAC program is to determine the lay navigator’s potential role in and beneficial effects on accrual and successful completion of clinical trials. Before a patient’s decision to accept or decline clinical trial participation is a process that may be influenced by multiple factors—presentation of a trial must attempt to address critical issues affecting a patient’s decision.21 Each patient has different concerns, biases, and levels of understanding; the physician, CRC, and navigator therefore must address a patient’s concerns as a team if they are to succeed in having the patient accept participation in the clinical trial.

ways during navigation. In addition to their use for preventing and addressing problems, these assessments are used to modify future training. ULAAC staff receive source-protected feedback to help validate quality and to modify training and/or navigation as needed. During navigation, patients complete a survey asking whether specific care processes occurred and whether they feel the assistance they received helped them overcome various barriers to care. Senior staff conduct separate telephone interviews with all patients using an expanded satisfaction questionnaire to gather supplementary data about navigation. For compliance oversight, 5% of patients are randomly queried on the appropriateness and propriety of the navigator interaction. A routine part of the navigation process is identification of patient-specific needs and barriers to care, both of which are thought to be key to the persistence of disparity. Charts and navigation records are audited to determine any unmet needs and barriers that have not been overcome. Staff follow up on deficiencies, which are identified and tracked in a database for later analysis aimed at developing new, more effective navigation strategies. Finally, as part of the overall project’s ongoing formative evaluation, RAND Corporation investigators (authors Allen Fremont and Nell Forge) independently assess various program aspects. For example, they conduct periodic focus groups with navigators, without ULAAC staff in attendance, and periodic interviews or surveys with selected staff and patients. Additionally, they attend some staff meetings and can access de-identified information about patients that navigators and ULAAC staff routinely collect for documentation and quality assurance. Because this evaluation is formative, ULAAC staff have been provided with feedback and suggestions shortly after the project began. RAND’s ongoing provision of feedback and the ULAAC staff’s continuous program-operations assessments based on collected data helped ensure the program’s rapid operational evolution.

RESULTS Quality Assessment and Assurance Process Integral to the ULAAC navigator program is the systematic, ongoing assessment process that enables real-time program evaluation and modification. This process offers not only systematic collection of data on patient progress and the navigator function, but also a compliance-driven, quality-assurance oversight mechanism to detect errors possibly requiring immediate correction. The multifaceted quality-assessment process queries navigators and patients multiple times in varied

Recruitment and screening of potential navigators using the processes described yielded more than 30 prospective candidates for each of the two rounds of navigator training offered thus far. After the initial telephone screening (which eliminated potentially poor candidates) and the 1-hour navigator orientation, 17 of 36 interested individuals completed the first 6-hour navigator training course, and 14 of 31 completed the second 6-hour course, for a total of 31 navigators. Twelve of these trainees were cancer survivors; 13 had a past or present employment background in some as-


pect of healthcare. Interestingly, 4 trainees were foreign-trained physicians not yet licensed to practice medicine. All individuals wanted to help others or ‘‘give back’’ to their community. Appropriate to the project’s intent, 24 trainees were African American, 6 were Latino, and 1 was Arab-American. Languages spoken fluently by the trainees included English, Spanish, French, Greek, and Arabic. Of the 31 trainees, 22 went on to navigate patients. Of the 9 people who completed training but did not begin navigating patients, 3 simply showed no further interest, 2 had employment conflicts, 1 had ‘‘personal problems,’’ 1 experienced cancer recurrence and left to attend to his/her own medical needs, 1 had immigration problems, and 1 lacked adequate skills for a patient assignment. In the first 7 months of operation, 135 patients were offered navigation services; 75 (56%) accepted and 60 (44%) declined. The most common reason for declining was feeling that one already had a strong support network and not perceiving a need for navigation (40 patients, 67% of the 60 who declined). Other reasons for declining were that one was being treated for cancer recurrence and thus had enough experience with the healthcare system to navigate it without help (4 patients, 7% of those declining); some patients wanted to maintain privacy (2 patients, 3%); 1 perceived a loss of personal independence with navigation (1 patient, 2%); and one was a physician with a medical background (1 patient, 2%). Some patients were unable to be contacted due to lack of having reliable phone service (5 patients, 8%). Of note, 7 patients (12%) declined navigation but agreed with ULAAC staff to continue being monitored. They are classified as ‘pending’ and are open to the possibility of accepting navigation services in the future. Data collection and analyses of overall results were still under way as we wrote this article, but preliminary assessments suggest very positive experiences by patients, navigators, and clinical staff thus far. Initial survey and interview assessments of patients’ experience with the navigation process show high levels of patient satisfaction. Some patients are considering becoming navigators themselves when treatment ends. Navigators that have completed training and begun navigating also report that program participation has been rewarding. One common theme emerging from focus group discussions is that navigators who have navigated patients self-report a high level of personal satisfaction from their work. Overall, navigators feel personally rewarded by being able to help patients with the complex process of going through cancer treatment.

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DISCUSSION Obtaining and completing optimal care for cancer is complicated by myriad medical, social, and economic factors that can create barriers to care, particularly for minority and low-income patients. The ULAAC program is 1 way to help these patients overcome the barriers. Our experience illustrates the feasibility of a community-based navigator program and highlights its potential benefits for patients, staff, and navigators themselves. The specific steps we took and issues we describe here relate to establishing and operating a comprehensive lay patient navigator program in a community hospital, and thus may not apply to all settings. Nonetheless, certain steps—eg, careful planning with input from key community and local-provider stakeholders before program implementation, and ongoing evaluation and input as the program matures—are likely fundamental to any navigator program’s success. The CPRP grant proposal stipulated 1 year to hire personnel and develop the infrastructure for the patient navigation and the clinical trials program in our ‘clinical trials-naive’ inner-city community hospital serving a minority and low-income patient population. Our hospital, like others in our circumstance, lacked many of the foundational aspects necessary to implement such programs. This deficit is precisely what the CDRP wanted to address.20 It took 15 months from grant notice to first patient navigated and 18 months to enter our first patient on clinical trail. We chose our navigator model—employing a large number of part-time lay navigators from the community—partly to include a diverse and community-representative set of navigators from different racial/ ethnic and socioeconomic groups, but also to avoid the potentially higher costs of using two or more professional navigators or case managers for the roles we envisioned. The precise costs for training and administration attributable to our lay navigator group are still being assessed; we did find, however, that community interest was surprisingly strong, and good candidates were relatively easy to recruit. A key factor in attracting enough suitable applicants was coordinating our efforts with and networking within community-based health organizations. Indeed, the ULAAC program experience to date demonstrates the importance of creating community connections, particularly with community leaders and salient nonprofit community organizations, local providers, and clinical staff at care sites where navigators will operate. At a minimum, centers considering establishing a navigator program should form a community advisory board and a medical advisory board. These groups proved invaluable for insights into local com-

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munity and medical needs at different program-development stages; they were also essential for maintaining credibility and building trust in the program. Once the basic program was operating and we had enough navigators, both groups encouraged expanding the navigator role to include community outreach, such as health fairs, health education seminars, and health screenings. Some navigators have already done this, and we intend to pursue this expansion of the navigator role. Two other key ingredients to our program’s success were continual reassessment of program aspects and willingness to modify the program. For example, a unique feature of ULAAC and its navigator program is its goal of facilitating enrollment in clinical trials whenever appropriate. The initial 6-hour training session included a brief module on clinical trials to familiarize navigators with the basics of clinical trials and benefits to patients who participate in them. However, focus-group feedback from navigators that had begun navigating showed that many still had significant concerns about clinical trials. Particularly, many navigators reflecting the community at large were suspicious of trials and reluctant to encourage their patients to participate. In response, we added a special training session that offered testimonials from cancer survivors who had participated in clinical trials, role plays, and opportunities for navigators to express and discuss concerns. This additional training session seemed to address some concerns, but we are now conducting a more systematic evaluation of potential effects of navigator biases—negative and positive—about cancer patient participation in clinical trials. Of note, 44% of patients chose not to be navigated. For the most part, the personal reasons given for nonparticipation seemed reasonable and not unexpected. Those with resources adequate to the challenge of cancer care did not feel that they required the help of navigation. We have looked to improve participation among those whose personal and outside resources appeared lacking, and those without telephone service, by sustained contact during their treatment course. Nevertheless, the phenomenon of nonparticipation has created an opportunity to compare outcomes between patients who accepted versus those who declined navigation. Utilizing survey and interview methodologies, we are currently assessing quantitative differences between the two groups in various quality of life domains including social/family well being, physical well being, emotional well being, and functional well being. In addition, we are looking at patient perceived differences in quality of care between the two groups. The ULAAC program represents a viable model for developing lay navigator programs in community hospitals. Preliminary assessments suggest that the pro-

gram has a positive effect on minority and low-income cancers patients’ experience with care and reduces barriers to care. Additional time and research are needed to fully assess program impact on care and outcomes. Continuing evaluation of the ULAAC lay navigator program’s processes and outcomes will further clarify the validity of this notion and will elucidate navigator and program characteristics associated with superior outcomes.

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