Electra D. Paskett

Patient navigation: State of the art or is it science?†

First implemented in 1990, patient navigation interventions are emerging today as an approach to reduce cancer disparities. However, there is lack of consensus about how patient navigation is defined, what patient navigators do, and what their qualifications should be. Little is known about the efficacy and cost‐effectiveness of patient navigation. For this review, the authors conducted a qualitative synthesis of published literature on cancer patient navigation. By using the keywords ‘navigator’ or ‘navigation’ and ‘cancer,’ 45 articles were identified in the PubMed database and from reference searches that were published or in press through October 2007. Sixteen studies provided data on the efficacy of navigation in improving timeliness and receipt of cancer screening, diagnostic follow‐up care, and treatment. Patient navigation services were defined and differentiated from other outreach services. Overall, there was evidence of some degree of efficacy for patient navigation in increasing participation in cancer screening and adherence to diagnostic follow‐up care after the detection of an abnormality. The reported increases in screening ranged from 10.8% to 17.1%, and increases in adherence to diagnostic follow‐up care ranged from 21% to 29.2% compared with control patients. There was less evidence regarding the efficacy of patient navigation in reducing either late‐stage cancer diagnosis or delays in the initiation of cancer treatment or improving outcomes during cancer survivorship. There were methodological limitations in most studies, such as a lack of control groups, small sample sizes, and contamination with other interventions. Although cancer‐related patient navigation interventions are being adopted increasingly across the United States and Canada, further research will be necessary to evaluate their efficacy and cost‐effectiveness in improving cancer care. Cancer 2008.

Incidence, Time Course, and Determinants of Menstrual Bleeding After Breast Cancer Treatment: A Prospective Study

PURPOSE To assess ovarian function using the surrogate of monthly bleeding after breast cancer treatment in premenopausal women. PATIENTS AND METHODS Five hundred ninety-five US women age 20 to 45 years were accrued from January 1998 to July 2002 within 8 months of diagnosis with stages I to III breast cancer (median follow-up 45 months). Daily bleeding records were obtained prospectively, as well as extensive clinical, demographic, quality of life, and treatment data. Repeated measures logistic regression was used to assess which variables were predictive of monthly bleeding. RESULTS Significantly different proportions of women had monthly bleeding depending on their age (P < .001), chemotherapy program (P < .001), and time since treatment regimen. In the month after the standard course of doxorubicin and cyclophosphamide (AC), whether or not followed by paclitaxel or docetaxel, approximately 16% had monthly bleeding compared with the cyclophosphamide, methotrexate, fluorouracil (CMF) group, in which 48% bled (P < .001). Following any AC regimen, there was a slow recovery phase of about 9 months followed by a plateau, during which almost half continued monthly bleeding for the remainder of the follow-up period compared with after CMF in which there was no recovery phase and a continual decline in monthly bleeding to approximately 18% of women at study end (P < .001). Tamoxifen use decreased bleeding between months 12 and 24 after chemotherapy with 15% fewer women having bleeding. CONCLUSION Using daily menstrual bleeding records, it is demonstrated that age, the specific chemotherapy regimen received, and tamoxifen use impact ovarian function.

Patient Navigation: An Update on the State of the Science

Although patient navigation was introduced 2 decades ago, there remains a lack of consensus regarding its definition, the necessary qualifications of patient navigators, and its impact on the continuum of cancer care. This review provides an update to the 2008 review by Wells et al on patient navigation. Since then, there has been a significant increase in the number of published studies dealing with cancer patient navigation. The authors of the current review conducted a search by using the keywords “navigation” or “navigator” and “cancer.” Thirty‐three articles published from November 2007 through July 2010 met the search criteria. Consistent with the prior review, there is building evidence of some degree of efficacy of patient navigation in terms of increasing cancer screening rates. However, there is less recent evidence concerning the benefit of patient navigation with regard to diagnostic follow‐up and in the treatment setting, and a paucity of research focusing on patient navigation in cancer survivorship remains. Methodological limitations were noted in many studies, including small sample sizes and a lack of control groups. As patient navigation programs continue to develop across North America and beyond, further research will be required to determine the efficacy of cancer patient navigation across all aspects of the cancer care continuum. CA Cancer J Clin 2011.

National Cancer Institute Patient Navigation Research Program: methods, protocol, and measures.

Patient, provider, and systems barriers contribute to delays in cancer care, a lower quality of care, and poorer outcomes in vulnerable populations, including low‐income, underinsured, and racial/ethnic minority populations. Patient navigation is emerging as an intervention to address this problem, but navigation requires a clear definition and a rigorous testing of its effectiveness. Pilot programs have provided some evidence of benefit, but have been limited by evaluation of single‐site interventions and varying definitions of navigation. To overcome these limitations, a 9‐site National Cancer Institute Patient Navigation Research Program (PNRP) was initiated.

The Epidemiology of Arm and Hand Swelling in Premenopausal Breast Cancer Survivors

Background: Breast cancer survivors suffer from lymphedema of the arm and/or hand. Accurate estimates of the incidence and prevalence of lymphedema are lacking, as are the effects of this condition on overall quality of life. Methods: Six hundred twenty-two breast cancer survivors (age, ≤45 years at diagnosis) were followed with semiannual questionnaires for 36 months after surgery to determine the incidence of lymphedema, prevalence of persistent swelling, factors associated with each, and quality of life. Results: Of those contacted and eligible for the study, 93% agreed to participate. Fifty-four percent reported arm or hand swelling by 36 months after surgery, with 32% reporting persistent swelling. Swelling was reported to occur in the upper arm (43%), the hand only (34%), and both arm and hand (22%). Factors associated with an increased risk of developing swelling included having a greater number of lymph nodes removed [hazards ratio (HR), 1.02; P < 0.01], receiving chemotherapy (HR, 1.76; P = 0.02), being obese (HR, 1.51 versus normal weight; P = 0.01), and being married (HR, 1.36; P = 0.05). Factors associated with persistent swelling were having more lymph nodes removed (odds ratio, 1.03; P = 0.01) and being obese (odds ratio, 2.24 versus normal weight; P < 0.01). Women reporting swelling had significantly lower quality of life as measured by the functional assessment of cancer therapy-breast total score and the SF-12 physical and mental health subscales (P < 0.01 for each). Conclusions: Lymphedema occurs among a substantial proportion of young breast cancer survivors. Weight management may be a potential intervention for those at greatest risk of lymphedema to maintain optimal health-related quality of life among survivors. (Cancer Epidemiol Biomarkers Prev 2007;16(4):775–82)

Racial differences in knowledge, attitudes, and cancer Screening practices among a triracial rural population

Low‐income, minority, and rural women face a greater burden with regard to cancer‐related morbidity and mortality and are usually underrepresented in cancer control research. The Robeson County Outreach, Screening and Education Project sought to increase mammography use among low‐income, minority, and rural women age > 40 years. The current article reports on racial disparities and barriers to screening, especially those related to knowledge, attitudes, and behaviors.

Cancer-Related Lymphedema Risk Factors, Diagnosis, Treatment, and Impact: A Review

PURPOSE Cancer-related lymphedema (LE) is an incurable condition associated with lymph-involved cancer treatments and is an increasing health, quality of life (QOL), and cost burden on a growing cancer survivor population. This review examines the evidence for causes, risk, prevention, diagnosis, treatment, and impact of this largely unexamined survivorship concern. METHODS PubMed and Medline were searched for cancer-related LE literature published since 1990 in English. The resulting references (N = 726) were evaluated for strength of design, methods, sample size, and recent publication and sorted into categories (ie, causes/prevention, diagnosis, treatment, and QOL). Sixty studies were included. Results Exercise and physical activity and sentinel lymph node biopsy reduce risk, and overweight and obesity increase risk. Evidence that physiotherapy reduces risk and that lymph node status and number of malignant nodes increase risk is less strong. Perometry and bioimpedence emerged as attractive diagnostic technologies, replacing the use of water displacement in clinical practice. Swelling can also be assessed by measuring arm circumference and relying on self-report. Symptoms can be managed, not cured, with complex physical therapy, low-level laser therapy, pharmacotherapy, and surgery. Sequelae of LE negatively affect physical and mental QOL and range in severity. However, the majority of reviewed studies involved patients with breast cancer; therefore, results may not be applicable to all cancers. CONCLUSION Research into causes, prevention, and effect on QOL of LE and information on LE in cancers other than breast is needed. Consensus on definitions and measurement, increased patient and provider awareness of signs and symptoms, and proper and prompt treatment/access, including psychosocial support, are needed to better understand, prevent, and treat LE.

Recruitment of minority and underserved populations in the United States: The centers for population health and health disparities experience

OBJECTIVE The recruitment of minority and underserved individuals to research studies is often problematic. The purpose of this study was to describe the recruitment experiences of projects that actively recruited minority and underserved populations as part of The Centers for Population Health and Health Disparities (CPHHD) initiative. METHODS Principal investigators and research staff from 17 research projects at eight institutions across the United States were surveyed about their recruitment experiences. Investigators reported the study purpose and design, recruitment methods employed, recruitment progress, problems or challenges to recruitment, strategies used to address these problems, and difficulties resulting from Institutional Review Board (IRB) or Health Insurance Portability and Accountability Act of 1996 (HIPAA) requirements. Additionally, information was collected about participant burden and compensation. Burden was classified on a three-level scale. Recruitment results were reported as of March 31, 2007. RESULTS Recruitment attainment ranged from 52% to 184% of the participant recruitment goals. Commonly reported recruitment problems included administrative issues, and difficulties with establishing community partnerships and contacting potential participants. Long study questionnaires, extended follow-up, and narrow eligibility criteria were also problematic. The majority of projects reported difficulties with IRB approvals, though few reported issues related to HIPAA requirements. Attempted solutions to recruitment problems varied across Centers and included using multiple recruitment sites and sources and culturally appropriate invitations to participate. Participant burden and compensation varied widely across the projects, however, accrual appeared to be inversely associated with the amount of participant burden for each project. CONCLUSION Recruitment of minority and underserved populations to clinical trials is necessary to increase study generalizbility and reduce health disparities. Our results demonstrate the importance of flexible study designs which allow adaptation to recruitment challenges. These experiences also highlight the importance of involving community members and reducing participant burden to achieve success in recruiting individuals from minority and underserved populations.

Phase II study of high-dose fish oil capsules for patients with cancer-related cachexia.

The authors undertook a multiinstitutional Phase II cooperative group study to examine the potential of oral fish oil fatty acid supplements administered at high doses to slow weight loss and to improve quality of life in patients with malignancy‐related cachexia.

Impact of Patient Navigation on Timely Cancer Care: The Patient Navigation Research Program

BACKGROUND Patient navigation is a promising intervention to address cancer disparities but requires a multisite controlled trial to assess its effectiveness. METHODS The Patient Navigation Research Program compared patient navigation with usual care on time to diagnosis or treatment for participants with breast, cervical, colorectal, or prostate screening abnormalities and/or cancers between 2007 and 2010. Patient navigators developed individualized strategies to address barriers to care, with the focus on preventing delays in care. To assess timeliness of diagnostic resolution, we conducted a meta-analysis of center- and cancer-specific adjusted hazard ratios (aHRs) comparing patient navigation vs usual care. To assess initiation of cancer therapy, we calculated a single aHR, pooling data across all centers and cancer types. We conducted a metaregression to evaluate variability across centers. All statistical tests were two-sided. RESULTS The 10521 participants with abnormal screening tests and 2105 with a cancer or precancer diagnosis were predominantly from racial/ethnic minority groups (73%) and publically insured (40%) or uninsured (31%). There was no benefit during the first 90 days of care, but a benefit of navigation was seen from 91 to 365 days for both diagnostic resolution (aHR = 1.51; 95% confidence interval [CI] = 1.23 to 1.84; P < .001)) and treatment initiation (aHR = 1.43; 95% CI = 1.10 to 1.86; P < .007). Metaregression revealed that navigation had its greatest benefits within centers with the greatest delays in follow-up under usual care. CONCLUSIONS Patient navigation demonstrated a moderate benefit in improving timely cancer care. These results support adoption of patient navigation in settings that serve populations at risk of being lost to follow-up.