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Lung Cancer Screening in the “Real World” and the Role of Nurse Navigators
Lung Cancer Screening in the “Real World” and the Role of Nurse Navigators
David E. Gerber, MD
Since the publication of the positive results of the National Lung Screening Trial (NLST)—the first lung cancer screening trial to demonstrate a reduction in lung cancer mortality—in the New England Journal of Medicine in 2011,1 several uncertainties regarding implementation of widespread lung cancer screening have arisen. Questions have focused on cost-effectiveness,2-4 the importance of smoking cessation,5 the high rate of false-positive screening studies,6,7 and the complexity and risks of subsequent biopsies and invasive staging procedures.8
However, little attention has been focused on protocol adherence and other navigational needs involved in such a program. Lung cancer screening represents a complex, multistep process, entailing at minimum 3 annual computed tomography (CT) scans, as well as additional imaging and/or biopsies for the projected 40% of individuals with suspicious radiographic findings.1 Given this complexity, characteristics of the target population, and experience in other cancer screening modalities, we anticipate that adherence will be a major factor in the feasibility and impact of lung cancer screening. We suggest that the unique skills of nurse navigators will be needed to guide patients through the complex screening protocol and assist with psychosocial and behavioral aspects.
WHAT DID THE NATIONAL LUNG SCREENING TRIAL SHOW?
In this multicenter study,1 over 53,000 high-risk participants were randomized 1:1 to annual chest x-ray (CXR) or low-dose helical CT scans for 3 years. Eligible patients were ages 55 to 74 years, had smoked at least 30 pack-years, had quit within the previous 15 years if former smokers, had no prior history of lung cancer, and had not undergone a chest CT in the preceding 18 months. In the CT arm, 24% of the screening studies were positive, of which 96% were false positives. There was a 20% reduction in lung cancer mortality and a 6.7% reduction in all-cause mortality in the CT arm. Impressively, adherence to the screening protocol across the 3 rounds was 95% in the CT arm and 93% in the CXR arm.
WHO PARTICIPATED IN THE NLST?
From August 2002 through April 2004, eligible participants were enrolled at 33 primarily academic centers in the United States.1 Recruitment strategies included direct mailings, local radio and newspaper advertisements, community outreach programs, and websites.9 Targeted recruitment of minority populations included translation of recruitment materials into multiple languages, advertising at minority-focused conferences, and using minority “ambassadors” in community settings. Approximately 60% of participants were men, and the mean age of the entire cohort was 60 years. Over 90% were white, 4% were black, and 2% were of Hispanic or Latino ethnicity.
How do these characteristics compare with the overall NLST-eligible US population? Reviewing the Census Department’s Tobacco Use Supplement of the Continuing Population Survey for 2002-2004 (the years of NLST recruitment) and focusing on NLST age and smoking history requirements, NLST participants were slightly younger but had similar sex and race/ethnicity distributions.9 However, NLST subjects were substantially more educated, with only 79% of the NLST-eligible US population having a high school diploma (compared with almost 94% of NLST participants) and 14% having at least a college degree (compared with 32% of NLST participants). NLST participants were less likely than the NLST-eligible population to be current (as opposed to former) smokers (48% vs 57%, respectively).9
AN NLST-ELIGIBLE POPULATION MAY BE AT HIGH RISK FOR NONADHERENCE AND HAVE UNIQUE BEHAVIORAL RESOURCE NEEDS
In the setting of a prospective clinical trial, NLST subjects were likely to have been highly motivated, monitored closely, and offered necessary behavioral and psychosocial resources. Outside of such a context, it is not known to what extent an eligible population will adhere to annual CT screens and subsequent evaluation of positive scans. Disparities in smoking status and education between NLST participants and screening-eligible individuals raise adherence concerns. Numerous studies have demonstrated that current smoking is associated with reduced adherence to medical recommendations, including breast, cervical, and colorectal cancer screening.10-16 For example, the Year 2000 Cancer Control Module of the National Health Interview Survey (CCM-NHIS) showed 12-month interval repeat mammography rates for 55- to 79-year-old women of 36% among current smokers compared with 44% of <6 year quitters and 58% of 6+ year quitters.15 In addition, among Spanish participants in the International Early Lung Cancer Action Program (I-ELCAP; a consortium of lung cancer screening sites), former smokers had better adherence to screening than did current smokers.17 Lower education is also a well-established predictor of nonadherence for breast, cervical, and colorectal cancer screenings.18,19 For example, CCM-NHIS data noted 12-month interval repeat mammography adherence of 35% among those with less than a high school education, compared with 63% of college graduates.15 Within an Early Lung Cancer Action Program study in the United States, a college degree was also predictive of adherence to the CT screening process.20
It is also not clear to what extent behavioral and psychosocial aspects (eg, smoking cessation, fears about lung cancer) will be addressed in lung cancer screening outside of a clinical trial setting. Lung cancer screening has been described as an important “teachable moment” in which smokers may be cognitively and psychologically primed for evidence-based cessation education and psychosocial interventions.21 A recent cost-effectiveness model for lung cancer screening clearly demonstrated the financial benefits of increased rates of smoking cessation among screening participants,2 and commentators have advocated for the addition of evidence-based cessation interventions to screening programs. However, it is not yet clear how smoking cessation and other behavioral resources would be incorporated into screening efforts or who would lead them.
HOW CAN NURSE NAVIGATION BE INCORPORATED IN LUNG CANCER SCREENING?
Across all aspects of the cancer care continuum (eg, screening, treatment, follow-up), nurse navigators provide instrumental and emotional support, address barriers to patient care, coordinate referrals, and strengthen patient-provider relationships.21-23 Navigation strategies have improved adherence to established screening processes for other malignancies, with the greatest impact among underserved populations. Across studies, navigation programs have resulted in substantial increases in breast, colon, and cervical cancer screening rates.22-24 For example, one randomized controlled trial demonstrated substantial improvements in colorectal cancer screening rates associated with culturally appropriate navigation (27% vs 12% for controls).25 Although not explicitly labeled as navigation, a nursing intervention approach was associated with increased adherence in Spanish sites of the I-ELCAP trial.17
Many aspects of nurse navigation for lung cancer screening could mirror features of these established, evidence-based models in other cancer screening contexts while also adding components specific to the screen-eligible population. Nurse navigators could help patients consider, schedule, and complete the CT screening tests. For patients who need follow-up care, nurse navigators could also help coordinate multiple medical services. In general, nurse navigators can assist patients through the sometimes overwhelming healthcare system as their medical needs are identified through the screening process. Behavioral and psychosocial education would be critical components of the effort, with particular focus on lung cancer risk reduction through the provision of evidence-based smoking cessation information and referrals to smoking cessation clinics. Nurse navigators are also able to provide monitoring of cessation adherence and other medically suggested lifestyle changes. This model would be consistent with emerging evidence that navigators in primary care and community medicine settings have important roles in facilitating smoking cessation and other health behavior changes.26,27 Throughout the process, navigators could also address logistic (eg, financial, transportation) and psychosocial (eg, anxiety, fear) barriers that may interfere with successful adherence to the lung cancer screening protocol and smoking cessation.
In conclusion, if lung cancer screening becomes widely implemented, experience with screening for other malignancies suggests that real-world adherence rates will be considerably less than the 95% in the NLST. In addition, behavioral needs, such as smoking cessation education, will be important issues to address in screening settings. Nonadherence—whether it takes the form of patients failing to undergo follow-up scans, declining recommended procedures such as biopsy, not seeking treatment for diagnosed disease, or never initiating the screening protocol—will threaten to undermine the mortality reduction achieved in the highly controlled NLST. Furthermore, lung cancer screening without significant risk reduction through smoking cessation will not maximize the mortality and cost benefits of the protocol. While it took decades after widespread implementation of other cancer screening programs to investigate the role of nurse navigation, given the increasing public focus on the cost and quality of medical care, it is not only reasonable but also imperative to consider and evaluate this approach early in the implementation of lung cancer screening.
Disclosures: David E. Gerber, MD, reports receiving support through a National Cancer Institute (NCI) Cancer Clinical Investigator Team Leadership Award (1P30 CA142543-01 supplement) and the North and Central Texas Clinical and Translational Science Initiative (NCTCTSI) (KL2RR024983). Alletrice O. Gillam, RN, BSN, OCN, has nothing to disclose. Heidi A. Hamann, PhD, reports receiving support through a grant from the National Lung Cancer Partnership and its North Carolina Chapter.
Corresponding author: Heidi A. Hamann, PhD, Departments of Clinical Sciences and Psychiatry, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX 75390; e-mail: firstname.lastname@example.org.
1. Aberle DR, Adams AM, Berg CD, et al, for the National Lung Screening Trial Research Team. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011;365:395-409.
2. McMahon PM, Kong CY, Bouzan C, et al. Cost-effectiveness of computed tomography screening for lung cancer in the United States. J Thorac Oncol. 2011;6:1841-1848.
3. Pyenson BS, Sander MS, Jiang Y, et al. An actuarial analysis shows that offering lung cancer screening as an insurance benefit would save lives at relatively low cost. Health Aff (Millwood). 2012;31:770-779.
4. Goulart BH, Bensink ME, Mummy DG, et al. Lung cancer screening with low-dose computed tomography: costs, national expenditures, and cost-effectiveness. J Natl Compr Canc Netw. 2012;10:267-275.
5. Evans WK, Wolfson MC. Computed tomography screening for lung cancer without a smoking cessation program—not a cost-effective idea. J Thorac Oncol. 2011;6:1781-1783.
6. Arenberg D, Kazerooni EA. Setting up a lung cancer screening program. J Natl Compr Canc Netw. 2012;10:277-285.
7. Sox HC. Better evidence about screening for lung cancer. N Engl J Med. 2011;365:455-457.
8. Wiener RS, Schwartz LM, Woloshin S, et al. Population-based risk for complications after transthoracic needle lung biopsy of a pulmonary nodule: an analysis of discharge records. Ann Intern Med. 2011;155:137-144.
9. Aberle DR, Adams AM, Berg CD, et al. Baseline characteristics of participants in the randomized national lung screening trial. J Natl Cancer Inst. 2010;102:1771-1779.
10. Lin JH, Zhang SM, Manson JE. Predicting adherence to tamoxifen for breast cancer adjuvant therapy and prevention. Cancer Prev Res (Phila). 2011; 4:1360-1365.
11. Nielsen MJ, Nørgaard M, Holland-Fisher P, et al. Self-reported antenatal adherence to medical treatment among pregnant women with Crohn’s disease. Aliment Pharmacol Ther. 2010;32:49-58.
12. Selvin E, Brett KM. Breast and cervical cancer screening: sociodemographic predictors among white, black, and Hispanic women. Am J Public Health. 2003;93:618-623.
13. Rakowski W, Clark MA, Ehrich B. Smoking and cancer screening for women ages 42-75: associations in the 1990-1994 National Health Interview Surveys. Prev Med. 1999;29:487-495.
14. Rakowski W, Clark MA, Truchil R, et al. Smoking status and mammography among women aged 50-75 in the 2002 behavioral risk factor surveillance system. Women Health. 2005;41:1-21.
15. Rakowski W, Breen N, Meissner H, et al. Prevalence and correlates of repeat mammography among women aged 55-79 in the Year 2000 National Health Interview Survey. Prev Med. 2004;39:1-10.
16. Subramanian S, Amonkar MM, Hunt TL. Use of colonoscopy for colorectal cancer screening: evidence from the 2000 National Health Interview Survey. Cancer Epidemiol Biomarkers Prev. 2005;14:409-416.
17. Montes U, Seijo LM, Campo A, et al. Factors determining early adherence to a lung cancer screening protocol. Eur Respir J. 2007;30:532-537.
18. Klabunde CN, Cronin KA, Breen N, et al. Trends in colorectal cancer test use among vulnerable populations in the United States. Cancer Epidemiol Biomarkers Prev. 2011;20:1611-1621.
19. Pruitt SL, Shim MJ, Mullen PD, et al. Association of area socioeconomic status and breast, cervical, and colorectal cancer screening: a systematic review. Cancer Epidem Biomar. 2009;18:2579-2599.
20. Wildstein KA, Faustini Y, Yip R, et al. Longitudinal predictors of adherence to annual follow-up in a lung cancer screening programme. J Med Screen. 2011;18:154-159.
21. Taylor KL, Cox LS, Zincke N, et al. Lung cancer screening as a teachable moment for smoking cessation. Lung Cancer. 2007;56:125-134.
22. Paskett ED, Harrop JP, Wells KJ. Patient navigation: an update on the state of the science. CA Cancer J Clin. 2011;61:237-249.
23. Burhansstipanov L, Dignan MB, Schumacher A, et al. Breast screening navigator programs within three settings that assist underserved women. J Cancer Educ. 2010;25:247-252.
24. Han HR, Lee H, Kim MT, et al. Tailored lay health worker intervention improves breast cancer screening outcomes in non-adherent Korean-American women. Health Educ Res. 2009;24:318-329.
25. Percac-Lima S, Grant RW, Green AR, et al. A culturally tailored navigator program for colorectal cancer screening in a community health center: a randomized, controlled trial. J Gen Intern Med. 2009;24:211-217.
26. Andrews JO, Felton G, Ellen Wewers M, Waller J, Tingen M. The effect of a multi-component smoking cessation intervention in African American women residing in public housing. Res Nurs Health. 2007;30:45-60.
27. Martinez-Bristow Z, Sias JJ, Urquidi UJ, et al. Tobacco cessation services through community health workers for Spanish-speaking populations. Am J Public Health. 2006;96:211-213.
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