Abstract: Cancer patients face a myriad of psychosocial and practical issues. Especially challenging is the time from an initial diagnosis to the onset of treatment, and patient navigation services are important to guide patients, especially underserved populations, through this maze of uncertainty. Here we report on the Pennsylvania Patient Navigator Demonstration Project (PaPND) designed to evaluate the acceptability, feasibility, and impact of a culturally and linguistically appropriate nonclinical navigator program. The development of the project, based on behavioral theory and community-based participatory research principles, is described. Forty-four cancer patients from diverse backgrounds participated in the study, which included a baseline assessment, navigation services, and a 4-week and 12-week follow-up assessment. On average, participants experienced 1.8 barriers, with transportation and insurance issues the most common barriers. The majority (56%) of the barriers required more than an hour of the navigator’s time to address, with insurance, transportation, and caregiver/support issues requiring the most time. Overall, patients were fairly satisfied with the navigation services. After patient navigation, the findings showed improvement in patients’ worry, their understanding of their disease, and their beliefs in the importance of treatment, as well as their own self-efficacy in managing cancer-related issues. Results also suggest issues that need to be addressed include providing and connecting cancer patients to appropriate information to improve their understanding of their diagnosis and their recommended treatments and areas in which the integration of nonclinical and clinical navigation is essential. In addition, more attention to the assessment of psycho social issues, such as the patients’ emotional worries, and more comprehensive training in these areas would enhance navigation programs.
Cancer patients from all backgrounds face a myriad of psychosocial and practical issues that impact their cancer diagnosis, treatment, and survivorship experience.1-3 The time from an initial diagnosis to the onset of treatment can be overwhelming for patients as they need to manage multiple providers and healthcare systems, understand their insurance coverage and the specifics of their diagnosis and treatment options, as well as deal with the emotional challenges of facing an often unexpected diagnosis.
Patient navigation programs and strategies have emerged as an important approach to addressing the range of psychosocial issues; access to care; and utilization of cancer screening, diagnostic, and treatment services.4 The role of patient navigation in cancer screening and care was initiated in the Harlem Cancer Education and Demonstration Project in the early 1990s, when patient navigation served as a means to improve timely movement along the cancer care continuum in medically underserved populations.5 Since that time, federally funded research has been implemented to evaluate the impact of patient navigation services, various government and voluntary agencies have developed patient navigation models and services, professional associations have emerged, and the evidence base supporting the positive effects of patient navigation has grown.6
Within the emerging field of patient navigation, 4 numerous models and approaches have been described, including clinical (often nurse navigators) and nonclinical (other health professionals and/or community health workers) navigation and mixed models that include both approaches.7-9 Often these different models are implemented based on where along the cancer continuum the patient navigation services are focused. Although current randomized control trials are expected to provide more definitive conclusions about impact and cost-effectiveness of patient navigation, there are lessons to be learned from ongoing program evaluations and demonstration projects focused on establishing and implementing patient navigation in real-world settings.10,11
Toward that end, we conducted a demonstration project, called the Pennsylvania Patient Navigator Demonstration Project (PaPND) funded by the Pennsylvania Department of Health. The aims of the PaPND were to evaluate the acceptability, feasibility, and impact of a culturally and linguistically appropriate navigator program relying on a nonclinical patient navigation model. Specifically, the role of the nonclinical navigators was to address psychosocial and access barriers for patients during the period between diagnosis and initiation of treatment. The program was guided by the Cognitive-Social Health Information Processing (C-SHIP) theoretical framework,2,3 which focuses on the cognitive and emotional factors as well as the practical skills that impact health behaviors. Our goal was to infuse these concepts into the navigator training and baseline assessment and evaluate the impact of navigation on these factors.
Our previous experience in service-related research12 supported our approach to the design and implementation of the program using community-based participatory research (CBPR)13,14 concepts by involving the sites in the grant application and project development process, funding a dedicated onsite navigator, jointly supervising the navigator, and participating in the evaluation. Navigation services were offered to all patients who had just been diagnosed with breast, cervical, prostate, colorectal, or lung cancer and were provided in both English and Spanish. The evaluation included data on barriers faced by participants, navigator’s time to address the barriers, impact on psychosocial needs, and satisfaction with the navigation services.
This nonrandomized, longitudinal 3-year demonstration project was developed and conducted at Temple University Hospital in Philadelphia, Pennsylvania. At the time that this project was initially planned, there were few patient navigation programs and even fewer best practice training and implementation tools. Therefore, we developed a patient navigator training program and institution-specific implementation procedures and processes; we also designed and conducted a program evaluation.
Temple University Health System (TUH) is an urban 514-bed tertiary medical center, which provides care to over 20,000 inpatients and 150,000 outpatients annually. The hospital serves a predominantly low-income population, and the patient population is 47% African American and 14% Hispanic. This site was chosen to address the needs of historically medically underserved populations. This study was approved by the Institutional Review Board at Fox Chase Cancer Center and Temple Medical System.
Inclusion/Exclusion Criteria of Participants
Eligible participants were at least 18 years of age, with a diagnosis of breast, cervical, colorectal, prostate, or lung cancer. Participants were ineligible for the study if they could not speak English or Spanish, were unable to give proper informed consent, or had already begun treatment for their cancer diagnosis. Participants were referred to the program by physicians, radiologists, and pathologists or were identified directly by the navigator as eligible for the program.
Development of Program and Training
Building on the emerging literature on patient navigation and CBPR principles, procedures and processes were developed in collaboration with the implementation-site investigator and key hospital staff. The key goals were to develop the navigator job description, determine the organizational reporting structure, install the navigation tracking software, study procedures and processes, and oversee ongoing project management. Fox Chase Cancer Center research staff focused most on the research study implementation while the community-based cancer center focused on case management of patient care and treatment.
The integration of research and service was overseen by project managers at both sites through weekly contact to coordinate, review, and discuss the research study, implementation, research issues, and data collection. Management and administration of the patient navigation program also required considerable logistical coordination, involving numerous planning meetings, participation in various cancer program meetings to address potential concerns, and development of an implementation process that was congruent with hospital operations and policies. The team addressed program planning with collaborative and creative coordination, including the development of a customized contact-management software package (SugarCRM Enterprise), which provided a system to keep notes on each contact with participants and any follow-up with other entities (eg, insurance company, transportation, primary care, etc).
A comprehensive, 2-week navigation training, modeled on the National Cancer Institute’s (NCI) Cancer Information Service training and the Pfizer Patient Navigation in Cancer Care Toolkit, included face-to-face sessions with a staff trainer, self-directed learning modules, and 2 online sessions. Topics covered included basic cancer concepts, the cancer continuum, resources, and barriers to treatment. Training was also provided on key navigator skills such as assessment and problem identification, the navigator’s role and responsibilities, and communication skills. The CSHIP framework was integrated throughout the training to ensure that the patient navigator understood the importance of both cognitive and affective issues as well as how to address these issues when providing navigation services. The training also included a component on the value of research as well as Health Insurance Portability and Accountability Act (HIPAA) and Human Subjects Protection certification.
Navigator Qualification and Training
The patient navigator was recruited and hired by TUH, with the assistance and consultation of Fox Chase Cancer Center. The navigator possessed a bachelor’s degree in social work, was bilingual (English/Spanish), and was from the community in which participants were recruited, giving her an intimate knowledge of the community’s population and resources. She had no previous experience with formalized patient navigation or behavioral research. Once hired, Fox Chase provided the navigator with in-depth training on patient navigation. The implementation site provided its own institutional orientation.
Patients were identified by the registration list or by direct referral from providers. The patient navigator first contacted eligible individuals by phone to obtain provisional informed consent and then secured final, written informed consent and HIPAA authorization at the first faceto- face clinic appointment. In addition, the navigator administered a baseline psychosocial survey and identified barriers to obtaining treatment and care. Two follow-up telephone assessments were administered by study research assistants at 4- and 12-weeks after the baseline assessment to determine the impact of the navigator intervention.
Self-reported patient satisfaction was included in both the 4 and 12-week assessments. All study measures and follow-up interviews were conducted in either English or Spanish, as appropriate. To track barriers and the services provided to each participant, the navigator used the tracking software. Data recorded in this log included participant demographics, participant eligibility, barriers experienced, services provided, and the time period to address the recorded barriers. A section was available to record more detailed narrative. Individuals who were in need of navigator services but did not want to participate in the study were provided with these services. Figure 1 depicts the overall study design and implementation.
Study Measures and Analysis
The baseline survey was used to provide the initial patient needs assessment as well as to collect data for the study evaluation. The baseline measures included demographics, health status, cancer diagnosis, and perceived barriers to care. The barriers were categorized using the C-SHIP framework into (1) practical barriers (ie, health insurance copays), (2) negative cognitions (eg, lack of understanding of treatment procedures), (3) negative expectancies and beliefs (eg, fatalism), and (4) affective barriers (eg, worry about diagnosis). These measures were assessed not only at baseline but also at 4 weeks and 12 weeks post initial consult. A face-valid 9-item questionnaire on patient satisfaction, designed by the study team, was administered at both the 4- week and 12-week follow-up assessments. These questions evaluated participants’ satisfaction with the navigator services, such as receiving cancer-related information, assistance with insurance-related problems, and getting community services. Participants were asked to indicate their agreement with each statement on a 5-point scale (0 = “Not at all” to 4 = “Very much”), and then scores were summed for an overall satisfaction score.
After the initial consult and completion of the baseline survey, the navigator provided navigation services and tracked specific barriers that were addressed in the case management software. The navigator contacted the patients as needed during the treatment process. The barriers were tracked across the array of barriers (eg, transportation, scheduling, insurance, physical/ emotional support, housing/living issues, caregiver support, referral issues, other systems issues, and other financial issues). A barrier was defined as an issue described by the participant and subsequently addressed by the patient navigator. The navigator also recorded the time required to address each barrier.
Descriptive statistics were generated for all variables and barrier data. A 2-sided, nonparametric, Wilcoxon signed-rank test was used to ascertain the difference in satisfaction scores at 4 and 12 weeks. Significance was determined at the 0.05 level, and data analysis was done using SAS version 9.2.
Participants enrolled in the study (N = 44) provided written consent and completed the baseline assessment. Table 1 shows the baseline characteristics of the study population. All participants were followed up after 4 weeks, and about 80% were followed up after 12 weeks.
The mean age of the enrolled participants was 56.7 years (SD = 11.7; median = 55). The majority were African American (64%), were women (82%), earned less than $15,000 annually (63%), were unemployed (91%), and had a high school education or less (80%). Breast and prostate cancers represented over 70% of the case load. Just under one-third of participants reported being Hispanic/Latino.
Addressing Identified Barriers
On average, participants experienced 1.8 barriers (SD = 1.1; min = 1; max = 4). Figure 2 describes the types of barriers addressed by the navigators. Transportation and insurance issues (practical barriers) were the most common, representing nearly 60% of all the barriers addressed. Support issues (physical, emotional, caregiver) represented nearly 20% of the barriers addressed. We also reviewed the time required to address these barriers and created 3 categories: 30 minutes or less; 30 to 60 minutes, and greater than an hour. The majority (56%) of the barriers required more than an hour of the navigator’s time to address, with insurance, transportation, and caregiver/ support issues requiring the most time (Table 2).
Satisfaction was assessed through telephone follow- ups, and satisfaction items addressed how the navigator helped with cancer-related information, provided help with insurance and various medical services, was culturally sensitive, and helped with family and other responsibilities. Higher scores indicated higher levels of satisfaction. The highest-rated items included seeking cancer-related information, access to care and community services, and being culturally sensitive (Table 3). There was improvement, although not significant, in specific measures over time. The overall satisfaction score significantly increased from 4 weeks (2.7) to 12 weeks (3.5). Table 3 depicts the mean scores of each of the 9 satisfaction items.
Impact of the Navigator Interventions on Changes in Cognitive-Affective Measures
Descriptive and exploratory analyses were conducted for the cognitive-affective measures that were evaluated through self-reported assessment at baseline, 4 weeks, and 12 weeks. The measures were assessed on a 5-point scale (1 = “Strongly disagree” to 5 = “Strongly agree”). These measures included cancer worry, knowledge about treatment, beliefs about following the treatment regimen, and ability to cope with self–management related issues. Table 4 shows the mean and standard deviation of the items that showed significant changes on the post navigation assessment. Higher scores reflect more positive self-perceptions, except for worry measures. Two of the knowledge-related measures showed significant improvement at 12 weeks. Reductions in worry about the cancer diagnosis, pain, life changes, and embarrassment were seen at 4 and 12 weeks. Expectancies and beliefs or values/goals measures also showed improvement. Patients reported higher scores on the importance of adhering to the treatment plan, following through with physician recommendations, and the importance of family support. In regard to self-regulatory skills, patients reported improvements in management of distress, ways to cope with financial related issues, remembering appointments, and managing other responsibilities.
The Pennsylvania Navigating Cancer Patients (PaPND) demonstration project evaluated the acceptability, feasibility, and impact of a culturally and linguistically appropriate patient navigator model in an urban hospital. Findings from this study contribute to the emerging literature base that investigates the use of navigation during the period from cancer diagnosis to treatment. The PaPND had a modest budget and focused primarily on the process of implementing a nonclinical patient navigator program and the impact on psychosocial issues among an underserved population. The findings support that the program was feasible and that patients were satisfied with the navigation services. Of note, the navigator role was continued by TUH after the project ended.
A number of important features of this study should be noted. It is one of the few studies that were conducted in both English and Spanish, with bilingual navigation, bilingual research staff, and Spanish language study instruments. It also relied on CBPR principles and involved the implementation site in all stages of the project. We utilized a dynamic management structure by which the research institution managed the research protocol remotely and the study-site institution managed the day-to-day navigator responsibilities. Remote management made it more difficult for the research institution to assess the navigator’s fidelity to the recruitment protocol and to determine when booster research trainings were necessary. However, the study site was involved in a number of decision-making processes (management, budgeting, and administrative processes). Perhaps the major challenge was the integration of service and research, with hospital leadership having limited experience in research. Future projects might consider focusing on the value and skills of research using CBPR or other community-engaged approaches to ensure more integration between the research institution and the practice institution.15
The results of the evaluation indicate that the patient navigator addressed close to 2 barriers per patient. The primary barriers were practical concerns, such as transportation and insurance, and these barriers required considerable time to address. However, almost 1 in 5 barriers were in the psychosocial domain, and the follow-up results indicate significant improvement in stress-related thoughts and key psychosocial measures, including a reduction in cancer-related worry. Overall, the participants were satisfied with the services of the patient navigator, especially related to the barriers that were addressed. The program was well received by the implementation site as indicated by the active participation throughout the entire project. Im - pressively, as a result of the study, the hospital elected to make the patient navigator position a full-time, permanent position.
Our study experienced limitations and challenges. First, the sample size was smaller than we had anticipated. Based on projected caseloads at the implementation site, we expected to recruit 20 participants per month during the 18-month implementation for a maximum caseload of 350 participants. Of 147 participants who met the study’s eligibility criteria, only 44 consented to participate in the study. This low accrual rate might be attributed to patient skepticism regarding participation in research, the time required to complete the baseline assessment, and limited training of the navigator in the nature and value of research and the research process. More training in study recruitment might have been helpful since the patient navigator did not have previous experience in behavioral research. In scenarios in which there is limited or no experience in behavioral research, patient navigator training should include modules discussing the understanding of research, the value of conducting research, the role of research protocols, and the importance of accrual and program fidelity.
Although patients were satisfied, and the navigator addressed some of the critical issues regarding access to care, the evaluation results suggest that issues need to be addressed, including providing and connecting cancer patients to appropriate information to improve their understanding of their diagnosis and recommended treatments and identifying where the integration of clinical navigation is essential. In addition, more attention to the assessment of psychosocial issues, such as the patients’ emotional worries, and more comprehensive training in these areas would enhance navigation programs.
As patient navigation in cancer care becomes a standard component of patient-centered care, it is important to explore the various models of navigation and evaluate the adaptation of patient navigation functions across the cancer continuum. The large, NCI-funded Patient Navigation Research Program studies will undoubtedly fill existing empirical gaps on the impact, cost-effectiveness, and sustainability of navigator programs.11,16,17 In addition, there is a need to evaluate the feasibility of implementing patient navigation programs at the community level18-20 as this is still where much cancer care is delivered. This study and others will provide valuable information to determine the re - sources, both in personnel and infrastructure, that are necessary to promote sustainability in the real-world, community setting.11 As patient navigation is emerging as a viable intervention to reduce patient, provider, and systems barriers, 11 it is important to explore how to expand these programs to systematically assess and address the broad array of psychosocial issues that face patients along their journey from diagnosis to survivorship.
Suzanne Miller, PhD
Senior Member and Professor
Director, Psychosocial and Biobehavioral
Fox Chase Cancer Center
Robert C. Young Pavilion
333 Cottman Ave. - 4th Floor
Philadelphia, PA 19111
DISCLOSURE OF FUNDING
This work was supported by a grant from the Pennsylvania Department of Health.
The authors want to acknowledge the efforts of each implementation site, especially project coordinators and patient navigators. In addition, we acknowledge the support of Fox Chase Cancer Center’s Behavioral Core Facility and the Office of Health Communications & Health Disparities.
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