Cancer Prevention and Control Program
Recent accomplishments of the Cancer Control Program include:
- Publication of key papers establishing the clinical feasibility and impact of offering rapid genetic counseling and testing to newly diagnosed breast cancer patients (Schwartz et al., 2004; 2005; Tercyak, 2007)
- Conduct of the first randomized-controlled trial to evaluate the effectiveness of the most widely used internet-based smoking cessation program (R01 CA104836, Graham).(Graham et al., 2006; Graham et al., 2008)
- Coordination of national collaborative modeling project to inform US Preventive Services Task Force Breast Cancer Screening Guidelines (Mandelblatt et al., in press)
Additionally, there are many ongoing studies:
- Impact and Outcomes of Cancer Genetic Testing
- Tobacco Control
- Early Detection Studies
- Outcome Studies
- Survivorship and End-of-Life Care Studies
- Prevention Studies
- Early Detection Studies
- Outcome Studies
- Prevention Policy Studies
- Early Detection Policy Research
- Survivorship/End of Life Policy Research
The CC Program has an active and highly collaborative research group focused on genetic counseling and testing for cancer susceptibility that spans our Program Aims. This group includes CC investigators (Drs. Schwartz, Tercyak, O'Neill, Graves, and Ms. Peshkin) and inter-programmatic collaborators (Drs. Isaacs, Willey, Shields). These studies have benefited from Lombardi resources such as the FCR. These investigators have conducted a series of seminal studies examining the impact and outcomes of genetic testing for cancer susceptibility. For example, Dr. Schwartz (in collaboration with Drs. Tercyak, O'Neill, Graves, Isaacs, Willey, and Ms. Peshkin) continues to conduct innovative translational research on the clinical integration of BRCA1/2 testing in the context of newly diagnosed breast cancer (R01 CA74861). In an initial prospective study, Dr. Schwartz and colleagues evaluated the feasibility and impact of delivering genetic counseling and testing at the time of diagnosis (Schwartz et al. 2004; 2005). Results indicated that patients who learned that they carried a BRCA1/BRCA2 mutation at the time of their initial breast cancer diagnosis were 4-times more likely to receive an immediate bilateral mastectomy compared to women who received negative results. The publication of these results was accompanied by an editorial in the Journal of Clinical Oncology (Daly, 2004).
In subsequent analyses, Dr. Tercyak found that the decision to obtain an immediate bilateral mastectomy (BLM) at the time of diagnosis did not adversely impact subsequent quality of life (Tercyak et al. 2007). These results were supported by evidence from a separate cohort indicating a high rate of BLM and generally positive quality of life outcomes following BLM (Graves et al., 2007). These studies have directly contributed to the increasing clinical integration of pre-surgical BRCA1/2 gene testing for newly diagnosed breast cancer patients with a family history suggestive of hereditary cancer. This work has led to a competitive renewal of R01 CA74861 for Dr. Schwartz and colleagues (Ms. Peshkin, Drs. Mandelblatt, Isaacs, and Willey) to conduct a multi-site randomized controlled trial of Rapid Genetic Testing versus Usual Care for newly diagnosed breast cancer patients. This trial will also translate behavioral research results on risk and decision making into public policy through an active collaboration between Drs. Schwartz and Mandelblatt to examine cost-effectiveness of rapid genetic counseling and testing in newly diagnosed high-risk breast cancer patients.
Nearly half of individuals tested for BRCA1/2 mutations receive uninformative test results. However, there has been surprisingly little research focused on individuals who receive such results. Given the uncertainty about breast and ovarian cancer risk associated with uninformative results, such results have the potential to adversely impact quality-of-life and complicate clinical decision making. Dr. O'Neill, has been at the forefront of studying outcomes associated with uninformative genetic test results. In a prospective study Dr. O'Neill (in collaboration with Drs. Schwartz, Isaacs, and Ms. Peshkin) examined the trajectory of distress among 209 women who received an uninformative BRCA1/2 test result. She found that distress declined from pretesting to 1-month post-disclosure, but remained stable thereafter. Learning that one carried a variant of uncertain clinical significance and entering testing with a high expectation for carrying a deleterious mutation predicted distress that persisted through the year after testing (Rini et al., in press). O'Neill and colleagues (O'Neill et al., 2006) also found that individuals who typically coped poorly with ambiguity reported greater cancer-related (P<0.01), general (P<0.05), and genetic testing distress (P<0.01) following an uninformative test result. Based partly upon these studies, Dr. Schwartz, in collaboration with Drs. O'Neill, Taylor, Tercyak, Isaacs, and Ms. Peshkin Â has been funded to extend this research to develop and evaluate an internet-based decision tool for women who have received uninformative BRCA1/2 gene test results (RO1 HG005055).
Dr. Tercyak has leveraged cancer center resources (e.g., Fisher Center; FCR) and collaborations within the CC (Schwartz, Peshkin) and BC (Isaacs) programs to develop a nationally recognized research program focused on the impact of cancer genetic testing on families and children. Dr. Tercyak was funded (R01 HG002686) to investigate parental decision making about the communication of maternal BRCA1/2 test results to adolescent children. Just over half of mothers who participated in genetic testing chose to communicate test results to their children. Factors that predicted parental communication included older child age, fewer parent-child communication barriers, more positive attitudes toward communication, lower parental stress and higher coping resources (p's <.05). Parents who tested positive were least likely to communicate their test results to their children. Mothers who did not disclose were less satisfied with their communication decision and reported greater distress compared to mothers who disclosed their results (p's<.05). These results suggest an opportunity to influence family communication through the provision of parent decision making assistance prior to the receipt of genetic test results. Dr. Tercyak's work in familial aspects of genetic testing for hereditary cancer is highly innovative. His focus on parent-child communication of genetic test results is unique and highly influential. The work described here led directly to Dr. Tercyak's current intervention trial focused on improving the outcomes of parent-adolescent communication of genetic testing results. To our knowledge, this is the first study to develop and test an intervention in this area.
The genetic testing research described in this section is an outstanding example of value added by Lombardi in that it utilizes the clinical and research infrastructure created by the Cancer Assessment and Risk Evaluation (CARE) program and the FCR shared resource to conduct studies that would otherwise not be feasible. This research area has also benefitted from the establishment of the Jess and Mildred Fisher Center for Familial Cancer Research under the direction of Drs. Schwartz and Isaacs. Through this Center, existing research and clinical programs will be further integrated and new research and clinical programs will be developed.
Another major emphasis of our prevention focus is to understand the determinants of smoking initiation and cessation. Dr. Tercyak's tobacco control research focuses on youth cigarette smoking, including a variety of at-risk younger subpopulations (e.g., with low attention/concentration, high hyperactivity/impulsivity). The rationale for these studies centers on a putative shared genetic risk for these quantitative traits and susceptibility to nicotine addiction. This work was conducted in collaboration with the CBE program (Dr. Shields) and a clinical partnership with the Department of Pediatrics (Dr. Abraham). Results from a series of studies examining predictors of smoking behavior among adolescents, show that smoking rates are nearly doubled among adolescents exhibiting these traits (Tercyak & Audrain-McGovern, 2003; Tercyak et al., 2003). Ongoing inter-programmatic research with the CBE program is examining whether these associations hold at the genotypic level.
Related studies have evaluated adolescent and adolescent health care providers' attitudes toward genetic testing for nicotine addiction susceptibility (Tercyak et al., 2006). Interest was lower among providers (40%), but providers who engaged in more regular tobacco screening (OR=4.1, 95% CI=2.2, 7.8, p<.01) and those who were more optimistic about genetics research and treatment (OR=2.5, 95% CI=1.4, 4.4, p<.01), were more interested in testing (Tercyak et al., 2007). In a survey of 232 adolescent medical providers, willingness to recommend genetic susceptibility testing for nicotine addiction or lung cancer risk was associated with the presence of a preexisting illness and substance abuse history, insurance coverage, and the availability of a genetics professional with whom to consult (O'Neill et al., in press). This research has contributed to an emerging focus within the CC Program (Tercyak, Schwartz, Graves, O'Neill, Potosky, Peshkin) and across other Lombardi Programs (Isaacs, Shields, Fitzgerald) on behavioral factors associated with cancer-related SNP testing.
In another line of novel tobacco research, Dr. Taylor has conducted research within the Lung Screening Study (LSS) and the National Lung Screening Trial (NLST) to examine whether lung cancer screening may serve as a â€˜teachable moment' for changing smoking behavior (Taylor et al., 2007). An abnormal lung cancer screening result was associated with increased motivation to stop smoking, whereas a normal result was associated with decreased motivation to stop smoking (p=.02). These data indicate that lung cancer screening may serve as a teachable moment for smoking cessation and that a smoking cessation trial within the context of lung cancer screening would be feasible. Dr. Taylor has also been approved by the PLCO to conduct a study of the predictors of long-term tobacco use among PLCO participants, utilizing data that are currently being collected by the PLCO trial. Finally, Dr. Taylor is collaborating with Dr. Tammemagi, an epidemiologist at Brock University in Ontario, on a similar study in the NLST participants, determining the predictors of smoking relapse and cessation among NLST participants. This research represents a major value-added by the Lombardi as it would not have been feasible without Lombardi participation as a PLCO/NLST site.
With funding from her Career Development Award (KO7 CA090352), Dr. Liang, in collaboration with Drs. Mandelblatt and Wang, has studied the role of culture in cancer screening among Chinese women. In a series of studies she found that Chinese women who maintained Eastern cultural practices (e.g., eating a diet that balanced hot and cold; favoring Eastern medicine over Western medicine) did not perceive themselves at risk for cancer (Liang et al, 2004). Based on these initial findings, she developed and validated a 30-item measure of Chinese cultural views on health and cancer (Liang et al, 2006). This scale has high predictive validity because older Chinese American women holding a traditional cultural view were less likely to adhere to breast, cervical, and colorectal cancer screening. Similarly, limited English proficiency was associated with low cancer screening adherence. This tool has subsequently been used in studies by Dr. Wang (in collaboration with Drs. Mandelblatt and Schwartz) further evaluating the impact of culture on screening practices in Chinese American women (Wang et al, 2006). Availability of this tool will facilitate an understanding of how cultural factors influence risk behaviors and has led to the development of culturally tailored decision aides. Lombardi has added value to these studies through the use of the Biostatistics and Bioinformatics Shared Resource (BBSR).
Working within the NCI's PLCO screening trial, Dr. Taylor, in collaboration with Drs. Gelmann Â and Isaacs, has studied the impact of screening and trial participation on both health-related quality of life (HRQL) and trial adherence (Taylor et al., 2004). Despite some short-term adverse affects of a false positive result, at follow-up (9 months), post-receipt of results there was no significant association between intrusive thoughts and false positive status. Of note, trial adherence was significantly better among participants who had received all normal results in the previous year's screening tests (94% adherence) than among those who received at least one abnormal result (79% adherence). It will be important to extend these results to screening behavior outside of clinical trials. This work shows the ability of our group to interact and leverage existing grants to generate new research. Most recently, Dr. Taylor has further leveraged the PLCO to look at outcomes for cancer survivors detected in the trial (see Outcomes Section, below).
Dr. Mandelblatt has examined the impact of shared decision making (SDM) on breast cancer outcomes among a large cohort of older women (Mandelblatt et al., 2006). The results indicated that SDM levels were higher among women who were 67 to 74 years (vs. 75+) (p<.01), were accompanied to consultation (p<0.01), and who sought information (p<0.01); these associations persisted after considering covariates. While SDM was not associated with surgical treatment decisions, greater SDM was associated with higher odds of having adjuvant treatment, controlling for clinical factors. Greater SDM was also associated with improved short-term satisfaction. This research indicates that aging was associated with different preferences and treatment behaviors and highlights the interaction between decision making research and cancer and aging research.
Given the link between age and treatment behaviors, Dr. Mandelblatt is presently analyzing preliminary data on chemotherapy decision making from a large national cohort of older women (65+ years) seen in 64 geographically dispersed Cancer and Leukemia Group B (CALGB) sites. She is collaborating with Drs. Taylor and Isaacs and a team of clinicians to collect data within 4-12 weeks of diagnosis. The average age of the more than 900 women enrolled in the study to date is 75.5 years (SD=5.9). Preliminary data indicate that 33% of these women would choose chemotherapy and its side effects for as little as 12 or fewer months gain in life expectancy. So far about 40% of women have received chemotherapy, with increasing rates of use with increasing clinical indications. Additional analyses will examine how policy and practice relevant factors, such as area Medicare fees for chemotherapy infusion, physician propensity to prescribe chemotherapy, and the setting of care, interact with patient and clinical factors in producing the observed treatment patterns. The success of this work led to the successful re-competition of the CALGB grant to extend the cohort to include 7 years of follow-up to examine determinants of the quality of survivorship care. This program of research also provided the springboard for the career development of Dr. Sheppard who obtained a diversity supplement to study the processes of care for minority older patients; that work supported her successful application for a career development award.
In work with breast cancer patients it is also clear that decision making takes place in different contexts for women from various race/ethnic and age groups. For instance, Dr. Mandelblatt and colleagues found that certain cultural values (e.g., emphasis on family and fatalism) caused women to forego chemotherapy (Kreling et al., 2006). Using funding from Dr. Huerta's Community Network Program, Dr. Sheppard built on these data to study how culture affects racial and ethnic disparities in breast cancer treatment. Participants expressed a need for better communication with cancer providers, a desire for improved communication skills, and the need for information in Spanish. In contrast to other populations, few Latino women wanted to participate in treatment decisions, preferring their physicians make the decisions. Four cultural factors central to decisions about breast cancer were familismo - collective loyalty to extended family; respecto - respect for the knowledge and authority of physicians; La Fe en Dios - faith in God; and to a lesser extent fatalismo - the belief that death is inevitable once diagnosed with cancer. Dr. Sheppard leveraged this qualitative work to obtain funding from the Komen Foundation to develop and pilot test a decision support intervention to improve decision-making and communication between Latino women with breast cancer and their providers. These breast cancer treatment and outcomes studies have employed Lombardi shared resources (BBSR) and have benefitted from collaboration with investigators from the BC Program.
Finally, Dr. Potosky is currently conducting research on prostate cancer treatment as part of the NCI CanCORS project. He is conducting analyses assessing the reasons for variations in cancer care and outcomes post-diagnosis, primarily focusing on initial, curative therapies but also on supportive care therapies. These analyses focus on patient-centric factors (including tumor factors that constitute biology) as well as culture, behaviors and the association of these on care. However, this work also extends beyond patient factors to include the physician and the health care system in which patients are treated.
Research on survivorship and end-of-life care is a developing area within the CC Program. Much of our work in this area is in the early stages. For example, since different race/ethnic groups may have differing cultural experiences of survivorship and end-of-life care, we are using our multidisciplinary strengths to build on work initially funded under Dr. Huerta's Community Network Program (CNP) to examine the needs of Latina breast cancer survivors. Working collaboratively with Drs. Mandelblatt Â and Huerta, Dr. Graves has leveraged CNP pilot funding to obtain a grant from the Komen Foundation to conduct a survey of Latino survivors to describe their needs and quality of life and to ascertain how their cultural perspectives affect their experiences. Ms. Kreling has also used the foundation of the CNP to form collaborations with Capital Hospice and Montgomery Hospice to examine cultural factors associated with Hospice use in Latinos and Whites in the greater Metropolitan DC area. In collaboration with Drs. Huerta and Mandelblatt, she has obtained two R03-level pilot grants through the CNP to begin this work and was able to leverage the results to obtain an ACS grant to pilot a randomized trial of lay health workers to improve end-of-life care in Latinos. The success of these junior investigators is evidence of the value added of being in a cancer center, the ability to leverage mentorship experience into grant funding, and the program-project-like infrastructure of the CNP.
Dr. Taylor, in collaboration with Dr. Isaacs, has been funded by the ACS to conduct the first study evaluating long-term quality-of-life outcomes among prostate cancer survivors who were participants in the PLCO trial. Male PLCO participants diagnosed with prostate cancer 5-10 years previously will be compared to a randomly selected cohort of male PLCO participants without cancer. There are several crucial scientific, clinical, and policy issues that this study is poised to address. First, it is critical to understand if the quality of the years gained living with prostate cancer justifies the use of screening. Second, since it is possible that the main PLCO trial will never be able to "prove" that screening decreases mortality, the difference between screened and unscreened men may rest solely in quality-of-life differences. Third, few studies have provided a comparable healthy group to disentangle the effects of aging with the impact of screening and prostate cancer treatment. Fourth, Dr. Taylor will evaluate the impact of the potentially adverse effect of repeated false positive screening results on long-term outcomes. Finally, policy planners will benefit from the evaluation of the quality-of-life costs of screening, and whether there are differences among men diagnosed with cancer via screening compared to men diagnosed through usual care. This study highlights the leadership role of Dr. Taylor in behavioral research being conducted within the PLCO, another active collaboration between Drs. Taylor and Isaacs on studies related to the PLCO, and the value-added by Lombardi as a PLCO site in facilitating Dr. Taylor's innovative behavioral research within this major U.S. clinical trial.
To further strengthen survivorship support and investigation, Lombardi recruited Dr. Potosky. Dr. Potosky plans to explore the risk factors (genetic, clinical, sociodemographic) for late/toxic effects among cancer survivors as part of improving personalized medicine. For instance, Dr. Potosky is currently involved in studies evaluating cardiotoxicity and Herceptin. He plans to initiate work at Lombardi evaluating late effects of androgen deprivation therapy among prostate cancer survivors. Dr. Potosky's larger goal is to better integrate Lombardi health services research with clinical epidemiology focusing on cancer survivors/patients.
Much of the prevention focus centers on genetic testing and tobacco control. For example, Dr. Schwartz has collaborated with Dr. Isaacs and Ms. Peshkin to develop an interactive decision aid designed to help BRCA1/2 mutation carriers make informed decisions about breast cancer risk management and to facilitate adherence to management guidelines (R01 CA82346). This study is highly innovative in its development and empirical evaluation of a potentially disseminable approach to improving the outcomes of women who have received positive BRCA1/2 test results (Kaufman et al., 2003). Results from a randomized, controlled trial against usual care indicated that the decision aid was particularly effective for mutation carriers who were having the most difficulty deciding how to manage their breast cancer risk. Compared to carriers who received usual care, those who received the decision aid prior to making a final management decision were more likely to reach a final management decision (p<.01), were more satisfied with their decision (p<.05), had less decisional conflict (p<.01), and were more likely to take action to reduce their risk of breast cancer (Schwartz et al., 2009; Schwartz et al., under review). Based on these results, Dr. Schwartz in collaboration with Drs. Isaacs, Graves, Taylor and Ms. Peshkin have submitted a proposal to conduct a randomized effectiveness trial to evaluate this decision aid when delivered via the Internet to a community-based clinical sample of women who have received positive BRCA1/2 testing results. This work is an excellent example of the translation of results to the development and evaluation of interventions. Further, this work highlights the value-added by the Lombardi through its support for the clinical genetic counseling/testing program, the Fisher Center, and the availability of clinical collaborators.
In tobacco research, Dr. Graham, in collaboration with Drs. Tercyak, Mandelblatt Â and Lopez Class is conducting novel research on how Internet technology can be used to reduce cancer risk in populations. This research focuses on reducing population smoking through innovative intervention delivery systems that can reach existing smokers effectively and efficiently. Her ongoing NCI-funded project (R01 CA104836) is one of the first large-scale evaluations of the effectiveness of Internet delivered smoking cessation treatment. This study is examining the efficacy and cost-effectiveness of a widely disseminated, evidence-based Internet intervention (www.QuitNet.com), delivered alone or in conjunction with telephone counseling, against a standard Internet comparison condition. Preliminary results suggest that up to 21% of smokers interested in cessation will enroll into the study (Graham et al., 2006) and that psychosocial measures are reliable when administered via the Internet (Graham et al., 2008). Leveraging resources from the CNP grant (PI, Huerta), Dr. Graham has also been funded (R21 CA133319) to develop and test strategies for recruiting Latino smokers to web-based cessation programs. The rationale for this project is based, in part, on the difficulty in recruiting Latinos in Dr. Graham's current RO1. This research will address the questions of whether web-based cessation programs work for Latinos, by what mechanisms, and at what cost. Results from this study will provide a transportable model for how to reach and recruit other racial/ethnic minority groups to web-based trials.
Drs. Liang and Wang have built upon their results to develop culturally-specific, linguistically appropriate, and theoretically guided cancer educational materials for the Chinese population. These materials are designed to promote cancer screening by directly addressing key cultural barriers. For instance, with pilot funding from the Komen Foundation, Dr. Wang developed and tested a culturally appropriate video to promote Chinese American women's awareness and knowledge about breast cancer and mammography. A preliminary evaluation (Wang et al., 2008) showed that the culturally-tailored video significantly increased non-adherent Chinese women's screening intentions, knowledge, perceived risk for breast cancer, and perceived benefits of mammography (p's<.001). Women were less likely to hold an Eastern view of healthcare and report barriers to screening after viewing the video (p<.01). Based on these results, Dr. Wang (in collaboration with Drs. Liang, Mandelblatt and Schwartz) obtained support from the ACS (MRSGT-05-104-01-CPPB), NCI (R03 CA117552) and Komen Foundation (POP0504327) to conduct a randomized trial examining the efficacy of this culturally tailored video in a broader and larger Chinese population. The video is being compared to a non-culturally tailored breast cancer video and a usual care condition. This study is one of the first to test whether cultural tailoring has an advantage over a non-tailored intervention on promoting screening behavior and reducing cultural and language barriers in Chinese populations. These studies have benefited from their use of the BBSR.
The difficulty in making medical decisions prior to the availability of definitive outcome data is a perennial issue in medicine. Widely applicable approaches are needed to facilitate informed decision making about multiple diagnostic and treatment decisions. Dr. Taylor has been a national leader in the development of interventions to assist men with the prostate cancer screening decision. These interventions may serve as a model for other complicated choices that patients are asked to make. In collaboration with other CC investigators (Drs. Davis and Schwartz), she has conducted a series of randomized trials testing a variety of materials designed to enhance informed consent and decision making for prostate cancer screening. For example, in a community study, Dr. Taylor compared a print booklet and a culturally tailored decision support videotape about prostate cancer screening for African American (AA) men (Taylor et al., 2006; Williams et al., 2008). The booklet and video resulted in a significant improvement in knowledge and a reduction in decisional conflict about screening, relative to the wait list control. This study was one of the first randomized intervention trials designed to address African American men's informed decision-making about prostate cancer screening. In an NCI-funded follow-up, Dr. Taylor conducted a 2x2 randomized trial to assess 1) an informational, print-based decision aid (IDA) vs. usual care (UC; NCI materials), and 2) the timing of information delivery (prior to screening day [home] vs. screening day [clinic]). The IDA/home condition resulted in reduced decisional conflict vs. the other conditions (p=.05). Knowledge also improved significantly in the IDA condition (p=.03). The impact of the interventions on screening outcomes and satisfaction at 1 year is being analyzed. Building further on this work, Dr. Taylor has received new funding to conduct a trial using the internet to supplement primary care discussions about prostate cancer screening (RO1 CA119168). Among a diverse sample of male primary care patients (n=1875), the study will compare the efficacy of (1) a new web-based, interactive decision support approach, (2) our existing print-based decision tool, and (3) usual care in a randomized, controlled trial. By moving this research out of the prostate screening setting and into the clinical setting, this research is the first step in the clinical dissemination of efficacious approaches to educating a heterogeneous group of patients about prostate cancer screening. As such, it begins to extend Dr. Taylor's work. These studies have benefitted from Lombardi clinical collaborators (e.g., Dr. Lynch).
CC investigators have developed and tested a number of interventions for breast and prostate cancer patients. Working with clinicians and patient advocates, Dr. Taylor has studied treatment decision making and treatment-related behaviors among men with localized prostate cancer. Although several options are available for management of localized prostate cancer, no option is clearly superior to others. Given the complexity of the decision and the role of individual patient preferences, decision aids have the potential to benefit men who are faced with this decision. Dr. Taylor and colleagues (Drs. Davis, Schwartz, Lynch) evaluated a computer-assisted tool to help men clarify their preferences and improve decision making and QOL outcomes. Among 133 men with newly diagnosed, localized prostate cancer, knowledge increased (p<.001) and decisional conflict decreased (p<.05) in both arms at one-month post diagnosis. Use of the CD was associated with increased involvement in one's medical care (p<.05; Taylor et al., 2007). Ongoing analyses focus on long-term prostate cancer outcomes and treatment decisions.
Dr. Sheppard and her team developed a navigator guide and personalized patient worksheet designed to improve communication and quality-of-life outcomes for Latinas. In this work, all women were receptive to the intervention and having a Latina survivor as a navigator (Sheppard et al., 2008). Dr. Sheppard is now testing the efficacy of the intervention among Latinas with breast cancer. Dr. Sheppard has leveraged this experience to obtain funding from the ACS (Grant no. MRSGT-06-132-01-CPPB) and the Komen Foundation (Grant no. POP23806) to conduct a cohort study examining how race and culture influence decision making about chemotherapy use in Black and White breast cancer patients and how decisions affect QOL outcomes. The cancer center environment, with its clinical MedStar network, has provided the infrastructure to make this work possible.
Ms. Peshkin, in collaboration with Dr. Pollitz (PI) of Georgetown's Public Policy Institute, collaborated on a scenario-based survey study (Nathan Cummings Foundation #05-01008) assessing medical underwriting practices in the individual insurance market and compliance with current regulations regarding the use of genetic information for this purpose. Underwriters from major insurance companies indicated that there was little guidance for how to consider genetic status in underwriting decisions. In nearly 10% of the 92 underwriting decisions that were proposed, the underwriters would deny coverage, place a surcharge on premiums, or limit covered benefits based on the applicant's genetic information (Pollitz et al., 2007). These results led to a summary "white paper" that was presented to Congress in 2007.
Dr. Tercyak has been conducting work in collaboration with investigators from the University of the District of Columbia and the CBE Program through the collaborative U56 grant (U56 CA101429). This collaboration has focused on tobacco marketing to urban, minority youth (Johnson et al., 2008). This ongoing project, which would not have been possible without the value added from this Lombardi/University of the District of Columbia interaction, has led to Dr. Tercyak's invitation to co-author chapters on tobacco control for the DC Cancer Control Plan. The research involvement of Dr. Tercyak and other CC Program members on the plan provided the evidence needed for the allocation of tobacco settlement funds ($30 million) to fund the DC Cancer Control Plan.
Dr. Mandelblatt is at the forefront of highly innovative research focused on driving health policy debates through cost-effectiveness modeling. She has completed several studies to inform health policy debates related to cancer screening for various age-groups. The results of one study show that although mammography screening over the entire lifespan (starting at age 50) results in the most favorable stage distribution, it is costly to achieve this stage shift. The most innovative part of this work was the examination of screening benefits and costs as a function of women's health status. For instance, if women are screened until age 79 (vs. 70), it costs $82,000 per year of life saved. However, if screening is directed to the healthiest women (top 25% of life expectancy), costs drop to $58,000 per year of life saved (Mandelblatt et al., 2005). This work was highlighted with an editorial and led to Dr. Mandelblatt's participation in formulating the most recent ACS guidelines for screening older women for breast and cervical cancer.
More recently, Drs. Mandelblatt and Stoto led a team evaluating alternate mammography screening strategies using six of the CISNET simulation models. The models used common age-specific data for incidence, competing mortality, mammography characteristics, and treatment effects to compare 20 strategies with varying ages of initiation and cessation applied annually or biennially to a U.S. cohort. The models produced consistent results on the ranking of the strategies. Biennial screening predominated among efficient strategies and maintained 70% to 98% of the benefit of annual screening with the fewer false positive results. Screening biennially from age 50 to 69 is an efficient strategy in all models and achieves a median 20% (range, 13%-28%) breast cancer mortality reduction (vs. no screening). Initiating biennial screening at age 40 requires more mammograms and only reduces mortality an additional 2.5%. Strategies that continue screening from age 69 to either age 74, 79 or 84 yield additional mortality reductions in five of six models. These latter strategies are of fairly similar efficiency although over-diagnosis increases after age 70. Although these results cannot inform individual decisions, they suggest that on a societal basis biennial screening achieves the majority of benefits of annual approaches with fewer resources and less harm (Mandelblatt et al., in press). These results were used to inform the updated US Preventive Services Task Force Recommendations for breast cancer screening in the US and led to an invitation to Dr. Mandelblatt to present the results to the NCI's Board of Scientific Advisors (2008).
In other policy modeling work, Drs. Mandelblatt and Stoto have evaluated the contributions of screening and treatment dissemination on incidence and mortality trends in breast cancer between 1975 and 2000. Model results indicate that screening and treatment contributed about equally to the observed age-adjusted mortality reductions (Mandelblatt et al 2006). This work was conducted as part of the NCI-funded Cancer Intervention and Surveillance Modeling Network (CISNET). A paper summarizing the results of all seven modeling groups involved in the CISNET collaborative was published in the New England Journal of Medicine (Berry et al., 2005; accompanied by an editorial) and another describing her results in the Journal of the National Cancer Institute (Mandelblatt et al., 2006). Dr. Mandelblatt's group (represented by "G" on the figure estimated that mortality was reduced by 12.5% as a result of screening and 14% by diffusion of use of tamoxifen and multi-agent chemotherapy. This work led to a successful re-competition for Dr. Mandelblatt's CISNET grant for an additional five years and the award of a peer-reviewed supplement to Dr. Stoto examining dissemination of model results for local policy planning.
Dr. Mandelblatt recently extended her policy-related research to include a novel approach for assessing the economic value of interventions aimed at improving the quality of survivorship. Dr. Mandelblatt and colleagues evaluated the costs per intermediate behavioral outcome of three approaches to improve quality-of-life in a clinical trial with survivors making the transition from active treatment. They demonstrated that the most intensive intervention was not the most cost-effective and that it was important to assess the cost per unit outcome among subgroups of patients to understand what was most "cost-effective" (Mandelblatt et al., 2008). This work was novel in conducting an economic study alongside a behavioral trial. This type of work would not have been possible without the rich cross-disciplinary environment within the CC Program and Lombardi clinical collaborations.