Patient navigation moderates emotion and information demands of cancer treatment: a qualitative analysis.

PURPOSE: Patient navigation is increasingly employed to guide patients through cancer treatment. We assessed the elements of navigation that promoted patients' involvement in treatment among patients with breast and colorectal cancer that participated in a navigation study. METHODS: We conducted qualitative analysis of 28 audiotaped and transcribed semi-structured interviews of navigated and unnavigated cancer patients. RESULTS: Themes included feeling emotionally and cognitively overwhelmed and desire for a strong patient-navigator partnership. Both participants who were navigated and those who were not felt that navigation did or could help address their emotional, informational, and communicational needs. The benefits of logistical support were cited less often. CONCLUSIONS: Findings underscore the salience of personal relationships between patients and navigators in meeting patients' emotional and informational needs.

Randomized controlled trial of patient navigation for newly diagnosed cancer patients: effects on quality of life.

BACKGROUND: Patient navigation is a promising intervention to ameliorate cancer health disparities. This study objective was to measure patient navigation effects on cancer-specific quality of life (QOL) among patients with newly diagnosed cancer. METHODS: A randomized controlled trial of patient navigation was conducted in Rochester, NY. Patients with breast cancer and colorectal cancer were randomly assigned to receive a patient navigation intervention or usual care. QOL was measured at baseline and four subsequent time points, using the validated Functional Assessment of Cancer Therapy (FACT-B, FACT-C) instruments. RESULTS: Among 319 randomized patients (165 patient navigation, 154 control), median age was 57 years and 32.5% were from minority race/ethnicity groups. Patient navigation and control groups were comparable on baseline factors, except home ownership versus renting (more home ownership among controls, P = 0.05) and race (more whites among controls, P = 0.05). Total and subscale FACT scores did not differ between groups when analyzed as a change from baseline to 3 months, or at various time points. The emotional well-being subscale change from baseline approached significance (better change among patient navigation group, P = 0.05). Time trends of QOL measures did not differ significantly between groups. Adjustment for baseline patient factors did not reveal a benefit of patient navigation on QOL. CONCLUSIONS: In this randomized trial of patient navigation, there was no statistically significant effect on disease-specific QOL. IMPACT: These results suggest that patient navigation may not affect QOL during cancer treatment, that social/medical support are adequate in this study's setting, or that the trial failed to target patients likely to experience QOL benefit from patient navigation.

Understanding the processes of patient navigation to reduce disparities in cancer care: perspectives of trained navigators from the field.

Patient navigation (PN) programs are being widely implemented to reduce disparities in cancer care for racial/ethnic minorities and the poor. However, few systematic studies cogently describe the processes of PN. We qualitatively analyzed 21 transcripts of semistructured exit interviews with three navigators about their experiences with patients who completed a randomized trial of PN. We iteratively discussed codes/categories, reflective remarks, and ways to focus/organize data and developed rules for summarizing data. We followed a three-stage analysis model: reduction, display, and conclusion drawing/verification. We used ATLAS.ti_5.2 for text segmentation, coding, and retrieval. Four categories of factors affecting cancer care outcomes emerged: patients, navigators, navigation processes, and external factors. These categories formed a preliminary conceptual framework describing ways in which PN processes influenced outcomes. Relationships between processes and outcomes were influenced by patient, navigator, and external factors. The process of PN has at its core relationship-building and instrumental assistance. An enhanced understanding of the process of PN derived from our analyses will facilitate improvement in navigators' training and rational design of new PN programs to reduce disparities in cancer-related care.

Study protocol: a randomized controlled trial of patient navigation-activation to reduce cancer health disparities.

BACKGROUND: Cancer health disparities affecting low-income and minority patients are well documented. Root-causes are multifactorial, including diagnostic and treatment delays, social and financial barriers, and poor communication. Patient navigation and communication coaching (activation) are potential interventions to address disparities in cancer treatment. The purpose of this clinical trial is to test the effectiveness of an intervention combining patient navigation and activation to improve cancer treatment. METHODS/DESIGN: The Rochester Patient Navigation Research Program (PNRP) is a National Cancer Institute-sponsored, patient-level randomized trial (RCT) of patient navigation and activation, targeting newly-diagnosed breast and colorectal cancer patients in Rochester, NY. The goal of the program is to decrease cancer health disparities by addressing barriers to receipt of cancer care and promoting patient self-efficacy. The intervention uses trained, paraprofessional patient navigators recruited from the target community, and a detailed training and supervisory program. Recruited patients are randomly assigned to receive either usual care (except for baseline and follow-up questionnaires and interviews) or intervention. The intervention patients receive tailored assistance from their patient navigators, including phone calls, in-person meetings, and behind-the-scenes coordination of care. A total of 344 patients have been recruited. Outcomes measured at three month intervals include timeliness of care, patient adherence, patient satisfaction, quality of life, self-efficacy, health literacy, and cancer knowledge. DISCUSSION: This unique intervention combining patient navigation and patient activation is designed to address the multifactorial problem of cancer health disparities. If successful, this study will affect the design and implementation of patient navigation programs. TRIALS REGISTRATION: clinicaltrials.gov identifier NCT00496678.

Get screened: a pragmatic randomized controlled trial to increase mammography and colorectal cancer screening in a large, safety net practice.

BACKGROUND: Most randomized controlled trials of interventions designed to promote cancer screening, particularly those targeting poor and minority patients, enroll selected patients. Relatively little is known about the benefits of these interventions among unselected patients. METHODS/DESIGN: "Get Screened" is an American Cancer Society-sponsored randomized controlled trial designed to promote mammography and colorectal cancer screening in a primary care practice serving low-income patients. Eligible patients who are past due for mammography or colorectal cancer screening are entered into a tracking registry and randomly assigned to early or delayed intervention. This 6-month intervention is multimodal, involving patient prompts, clinician prompts, and outreach. At the time of the patient visit, eligible patients receive a low-literacy patient education tool. At the same time, clinicians receive a prompt to remind them to order the test and, when appropriate, a tool designed to simplify colorectal cancer screening decision-making. Patient outreach consists of personalized letters, automated telephone reminders, assistance with scheduling, and linkage of uninsured patients to the local National Breast and Cervical Cancer Early Detection program. Interventions are repeated for patients who fail to respond to early interventions. We will compare rates of screening between randomized groups, as well as planned secondary analyses of minority patients and uninsured patients. Data from the pilot phase show that this multimodal intervention triples rates of cancer screening (adjusted odds ratio 3.63; 95% CI 2.35 - 5.61). DISCUSSION: This study protocol is designed to assess a multimodal approach to promotion of breast and colorectal cancer screening among underserved patients. We hypothesize that a multimodal approach will significantly improve cancer screening rates.The trial was registered at Clinical Trials.gov NCT00818857.

Impact of genetic counseling and DNA testing on individuals with colorectal cancer with a positive family history: a population-based study.

What is the impact of a genetic evaluation for colorectal cancer susceptibility? We previously reported a study of individuals diagnosed with colorectal cancer at 60 years of age or less in a five-county area of New York including Rochester. Subjects reporting at least one first- or second-degree relative with colorectal cancer were invited to receive genetic counseling and DNA testing. Of the 37 persons tested, we previously reported that 6 were found to have deleterious mutations in MSH2 or MLH1. A mutation has since been found in a seventh subject in another laboratory. To evaluate the impact of the testing experience, we followed-up on 36 of these 37 subjects at 3 and 12 months after communicating their DNA test result. We ascertained their knowledge of colon cancer, whether they told relatives their test result, their surveillance behavior, and their mental health. Three months after receiving their result, subjects knew more about colon cancer if they had more cancer of all types in their family (p = 0.02). At 12 months, they knew more if they had been found to have a mutation (p < 0.001), were younger when DNA tested (p < 0.01), or were younger when diagnosed with cancer (p < 0.03). All but 1 of those found to have an abnormality told relatives. Relatives of 3 subjects in whom a mutation had been found came to us to be tested themselves. At 12 months, surveillance for colon and endometrial cancer was more adherent if there were more total cancers in the family (p < 0.05) or if the testee were more worried about cancer (p < 0.05). Self-assessed mental health at 12 months was better for those who were married (p < 0.05). This study suggests that individuals undergoing a genetic evaluation for an inherited susceptibility to colorectal cancer pursue recommended surveillance and inform relatives of their result.

Impact of genetic testing for breast-ovarian cancer susceptibility.

Previously, we have reported a clinical trial in which any woman in a defined geographic region who had a qualifying family history and who was referred by her physician or who was identified through a regional cancer registry was offered free genetic counseling, BRCA testing, and recommendations based on test results. Each family was represented by one affected and one unaffected person. Of the 87 families actually tested, 13 were found to have deleterious mutations. To assess the impact of the counseling and testing process, we contacted the tested individuals 1 month and 1 year after receiving the test result and those with an abnormal test result after 4 years. Index subjects, we found, differed significantly from relatives. Before coming for counseling, index subjects perceived both their general health and emotional health as worse than did their relatives. After counseling and testing, index subjects continue to worry more about breast cancer than do relatives. Affected subjects, we found, differed significantly from unaffected subjects. Before counseling, affected subjects knew more about breast cancer, perceived their general health as poorer, and reported greater adherence to recommended breast cancer surveillance than did unaffected subjects. After counseling and testing, affected subjects were less satisfied than unaffected subjects with having been tested. This study indicates that the group most prone to distress by cancer risk genetic counseling and testing is not the recruited relatives, nor even those affected with cancer, but rather the index patients themselves. The index patients, i.e., the ones who want the risk information most, appear to undergo the most stress in obtaining it.

Patient vs. physician as the target of educational outreach about screening for an inherited susceptibility to colorectal cancer.

Are patients identified from a cancer registry better educated directly or via their physician about screening for an inherited susceptibility for colorectal cancer? Of 974 patients diagnosed with colorectal cancer at < or = 60 years from 1987 to 1999 in a five-county area including Rochester, the physicians of 651 patients (67%) forwarded a cancer family history survey to their patient; 459 (71%) completed the survey. Of these 459, 167 (36%) reported having at least one first- or second-degree relative with colon cancer and were sent a set of questionnaires and a more detailed family cancer history form. Of the 167, a total of 101 (60%) continued to qualify by returning the questionnaires. These 101 qualifying patients were randomized to either the patient-education or physician-education group. Of the 101, a total of 47 (47%) came for a free genetic evaluation. Individuals were more likely to accept evaluation if they were parents (p = 0.001), had more cancers of all kinds in their families (p = 0.02), and had a larger social network (p = 0.04). Of the 47 counseled, 36 (77%) chose to have DNA testing at no cost. Of these 47, individuals were more likely to choose DNA testing if they had more cancers in the family (p = 0.04) and fewer symptoms of depression (p = 0.05). Of the 36 tested patients, 6 (20%) were found to have mutations. In summary, acceptance of genetic services was related to the magnitude of the threat (more cancers in the family), perceived ability to deal with the threat (perceived good health and a supportive network), and a desire to inform relatives (being a parent). The two approaches to educating patients, viz. direct patient education vs. education via their physician, did not significantly differ in terms of percentages of patients receiving counseling (42% vs. 51%, respectively) or the percentage choosing DNA testing (32% vs. 37%, respectively).