Genome-matched treatments and patient outcomes in the Maine Cancer Genomics Initiative (MCGI).

Genomic tumor testing (GTT) is an emerging technology aimed at identifying variants in tumors that can be targeted with genomically matched drugs. Due to limited resources, rural patients receiving care in community oncology settings may be less likely to benefit from GTT. We analyzed GTT results and observational clinical outcomes data from patients enrolled in the Maine Cancer Genomics Initiative (MCGI), which provided access to GTTs; clinician educational resources; and genomic tumor boards in community practices in a predominantly rural state. 1603 adult cancer patients completed enrollment; 1258 had at least one potentially actionable variant identified. 206 (16.4%) patients received a total of 240 genome matched treatments, of those treatments, 64% were FDA-approved in the tumor type, 27% FDA-approved in a different tumor type and 9% were given on a clinical trial. Using Inverse Probability of Treatment Weighting to adjust for baseline characteristics, a Cox proportional hazards model demonstrated that patients who received genome matched treatment were 31% less likely to die within 1 year compared to those who did not receive genome matched treatment (HR: 0.69; 95% CI: 0.52-0.90; p-value: 0.006). Overall, GTT through this initiative resulted in levels of genome matched treatment that were similar to other initiatives, however, clinical trials represented a smaller share of treatments than previously reported, and "off-label" treatments represented a greater share. Although this was an observational study, we found evidence for a potential 1-year survival benefit for patients who received genome matched treatments. These findings suggest that when disseminated and implemented with a supportive infrastructure, GTT may benefit cancer patients in rural community oncology settings, with further work remaining on providing genome-matched clinical trials.

The Maine Cancer Genomics Initiative: Implementing a Community Cancer Genomics Program Across an Entire Rural State.

PURPOSE: The Maine Cancer Genomics Initiative (MCGI) aimed to overcome patient- and provider-level barriers to using genomic tumor testing (GTT) in rural practices by providing genomic tumor boards (GTBs), clinician education, and access to comprehensive large-panel next-generation sequencing to all patients with cancer in Maine. This paper describes the successful implementation of the initiative and three key services made operative between 2016 and 2020. METHODS: A community-inclusive, hub-and-spoke approach was taken to implement the three program components: (1) a centralized GTB program; (2) a modular online education program, designed using an iterative approach with broad clinical stakeholders; and (3) GTT free of charge to clinicians and patients. Implementation timelines, participation metrics, and survey data were used to describe the rollout. RESULTS: The MCGI was launched over an 18-month period at all 19 oncology practices in the State. Seventy-nine physicians (66 medical oncologists, 5 gynecologic oncologists, 1 neuro-oncologist, and 7 pediatric oncologists) enrolled on the study, representing 100% of all practicing oncologists in Maine. Between July 2017 and September 2020, 1610 patients were enrolled. A total of 515 cases were discussed by 47 (73%) clinicians in 196 GTBs. Clinicians who participated in the GTBs enrolled significantly more patients on the study, stayed in Maine, and reported less time spent in clinical patient care. CONCLUSION: The MCGI was able to engage geographically and culturally disparate cancer care practices in a precision oncology program using a hub-and-spoke model. By facilitating access to GTT, structured education, and GTBs, we narrowed the gap in the implementation of precision oncology in one of the most rural states in the country.

Urban-Rural and Socioeconomic Differences in Patient Knowledge and Perceptions of Genomic Tumor Testing.

PURPOSE: Social determinants of health, such as rurality, income, and education, may widen health disparities by driving variation in patients' knowledge and perceptions of medical interventions. This effect may be greatest for medical technologies that are hard to understand and less accessible. This study explored whether knowledge and perceptions (expectations and attitudes) of patients with cancer toward large-panel genomic tumor testing (GTT), an emerging cancer technology, vary by patient rurality independent of other socioeconomic characteristics (education and income). METHODS: Patients with cancer enrolled in a large precision oncology initiative completed surveys measuring rurality, sociodemographic characteristics, and knowledge and perceptions of GTT. We used multivariable linear models to examine differences in GTT knowledge, expectations, and attitudes by patient rurality, education, and income level. Models controlled for age, sex and clinical cancer stage and type. RESULTS: Rural patients had significantly lower knowledge of GTT than urban patients using bivariate models (P = .025). However, this association disappeared when adjusting for education and income level: patients with lower educational attainment and lower income had lower knowledge and higher expectations (P ≤ .002), whereas patients with higher income had more positive attitudes (P = .005). Urban patients had higher expectations of GTT compared with patients living in large rural areas (P = .011). Rurality was not associated with attitudes. CONCLUSION: Patients' education and income level are associated with knowledge, expectations, and attitudes toward GTT, whereas rurality is associated with patient expectations. These findings suggest that efforts to promote adoption of GTT should focus on improving knowledge and awareness among individuals with low education and income. These differences may lead to downstream disparities in GTT utilization, which should be explored in future research.

Community oncologists' perceptions and utilization of large-panel genomic tumor testing.

PURPOSE: Large-panel genomic tumor testing (GTT) is an emerging technology with great promise but uncertain clinical value. Previous research has documented variability in academic oncologists' perceptions and use of GTT, but little is known about community oncologists' perceptions of GTT and how perceptions relate to clinicians' intentions to use GTT. METHODS: Community oncology physicians (N = 58) participating in a statewide initiative aimed at improving access to large-panel GTT completed surveys assessing their confidence in using GTT, attitudes regarding the value of GTT, perceptions of barriers to GTT implementation, and future intentions to use GTTs. Descriptive and multivariable regression analyses were conducted to characterize these perceptions and to explore the relationships between them. RESULTS: There was substantial variability in clinicians' perceptions of GTT. Clinicians generally had moderate confidence in their ability to use GTT, but lower confidence in patients' ability to understand test results and access targeted treatment. Clinicians had positive attitudes regarding the value of GTT. Clinicians' future intentions to use GTT were associated with greater confidence in using GTT and greater perceived barriers to implementing GTT, but not with attitudes about the value of GTT. CONCLUSIONS: Community oncologists' perceptions of large-panel genomic tumor testing are variable, and their future intentions to use GTT are associated with both their confidence in and perceived barriers to its use, but not with their attitudes towards GTT. More research is needed to understand other factors that determine how oncologists perceive and use GTT in clinical practice.

Patients' Expectations of Benefits From Large-Panel Genomic Tumor Testing in Rural Community Oncology Practices.

Large-panel genomic tumor testing (GTT) is an emerging technology that promises to make cancer treatment more precise. Because GTT is novel and complex, patients may have unrealistic expectations and limited knowledge of its benefits. These problems may limit the clinical value of GTT, but their prevalence and associated factors have not been explored. METHODS: Patients with cancer enrolled in a large initiative to disseminate GTT in community oncology practices completed surveys assessing their expectations, knowledge, and attitudes about GTT. The study sample (N = 1,139) consisted of patients with a range of cancer types (22% gynecologic, 14% lung, 10% colon, 10% breast, and 46% other malignancies) and cancer stages (4% stage I, 3% stage II, 15% stage III, and 74% stage IV). Mean age was 64 years (standard deviation = 11); 668 (59%) were women; 71% had no college degree; 57% came from households with less than $50,000 US dollars household income; and 73% lived in a rural area. RESULTS: Generally, patients had high expectations that they would benefit from GTT (M = 2.81 on 0-4 scale) and positive attitudes toward it (M = 2.98 on 0-4 scale). Patients also had relatively poor knowledge about GTT (48% correct answers on an objective test of GTT knowledge). Greater expectations for GTT were associated with lower knowledge (b = -0.46; P < .001), more positive attitudes (b = 0.40; P < .001), and lower education (b = -0.53; P < .001). CONCLUSION: This research suggests patients have high expectations that they will benefit from GTT, which is associated with low knowledge, positive attitudes, and low education. More research is needed to understand the concordance between expectations and actual clinical outcomes.

The influence of uncertainty and uncertainty tolerance on attitudes and self-efficacy about genomic tumor testing.

Novel medical technologies, like large-panel genomic tumor testing (GTT), offer great promise but also substantial uncertainty regarding their clinical value and appropriate use. The goal of this study was to understand how clinicians' perceived uncertainty about GTT, and uncertainty tolerance (UT), a construct that describes trait-level differences in individuals' responses to uncertainty, influence attitudes and self-efficacy regarding GTT. Community-based oncologists participating in a study of large-panel GTT completed surveys assessing their perceptions of uncertainty about GTT, and their attitudes and self-efficacy regarding GTT. Multivariable regression analyses examined the relationship between oncologists' perceived uncertainty of GTT and their GTT-related attitudes and self-efficacy, and the potential moderating effect of individual differences in UT. Fifty-seven oncologists completed surveys. Greater perceived uncertainty about GTT was associated with more negative attitudes towards it. This association was moderated by UT, such that lower UT was associated with a stronger negative relationship between perceived uncertainty and attitudes. That is, oncologists who perceive GTT as uncertain, tended to have more negative attitudes, particularly if they were low in the trait of uncertainty tolerance. More research is warranted to understand how uncertainty and uncertainty tolerance influence clinicians' responses to GTT and other novel medical interventions.

Involving American Indians and medically underserved rural populations in cancer clinical trials.

PURPOSE: To assess cancer clinical trial recruitment and reasons for nonaccrual among a rural, medically underserved population served by a community-based cancer care center. METHODS: We prospectively tracked clinical trial enrollment incidence among all new patients presenting at the Rapid City Regional Cancer Care Institute. Evaluating physicians completed questionnaires for each patient regarding clinical trial enrollment status and primary reasons for nonenrollment. Patients who identified as American Indian were referred to a program where patients were assisted in navigating the medical system by trained, culturally competent staff. RESULTS: Between September 2006 and January 2008, 891 new cancer patients were evaluated. Seventy-eight patients (9%; 95% confidence intervals, 7-11%) were enrolled on a clinical treatment trial. For 73% (95% confidence intervals, 69-75%) of patients (646 of 891) lack of relevant protocol availability or protocol inclusion criteria restrictiveness was the reason for nonenrollment. Only 45 (5%; 95% confidence intervals, 4-7%) patients refused enrollment on a trial. Of the 78 enrolled on a trial, 6 (8%; 95% confidence intervals, 3-16%) were American Indian. Three additional American Indian patients were enrolled under a nontreatment cancer control trial, bringing the total percentage enrolled of the 94 American Indians who presented to the clinic to 10% (95% confidence intervals, 5-17%). LIMITATIONS: Eligibility rates were unable to be calculated and cross validation of the number in the cohort via registries or ICD-9 codes was not performed. CONCLUSION: Clinical trial participation in this medically underserved population was low overall, but approximately 3-fold higher than reported national accrual rates. Lack of availability of protocols for common cancer sites as well as stringent protocol inclusion criteria were the primary obstacles to clinical trial enrollment. Targeted interventions using a Patient Navigation program were used to engage AI patients and may have resulted in higher clinical trial enrollment among this racial/ethnic group.

Assessing cancer stage and screening disparities among Native American cancer patients.

OBJECTIVE: Disparities in cancer-related health outcomes exist among Native Americans. This article assesses barriers to timely and effective cancer care among Native American cancer patients. METHODS: We conducted a community-based participatory survey of newly diagnosed cancer patients to assess their basic knowledge of cancer screening and their beliefs about cancer management. Sociodemographic and cancer-related information was obtained from medical records. Mean scores for correct answers to the screening knowledge battery were tabulated and analyzed by race/ethnicity and sociodemographic characteristics. Multivariable regression models were used to adjust for sociodemographic characteristics in evaluating the association between screening knowledge and race/ethnicity. RESULTS: The survey response rate was 62%. Of 165 patients, 52 were Native American and 113 were white. Native Americans with cancers for which a screening test is available presented with significantly higher rates of advanced-stage cancer (p=0.04). Native Americans scored lower on the cancer screening knowledge battery (p=0.0001). In multivariable analyses adjusting for age, gender, income, education level, employment status, and geographic distance from the cancer center, Native American race/ethnicity was the only factor significantly predictive of lower screening knowledge. Native Americans expressed more negative attitudes toward cancer treatment in some of the items regarding impacts and burden of cancer treatment. CONCLUSIONS: Native American cancer patients presented with higher rates of advanced-stage disease for screening-detectable cancers, lower levels of basic cancer screening knowledge, and more negative attitudes about cancer treatment than white patients. Public health interventions regarding screening and cancer education are needed.

Medical mistrust and less satisfaction with health care among Native Americans presenting for cancer treatment.

PURPOSE: To assess barriers to cancer care among Native Americans, whose health outcomes compare unfavorably with those of the general U.S. population. METHODS AND PATIENTS: We undertook a comparative community-based participatory research project in which newly-diagnosed cancer patients were prospectively surveyed using novel scales for medical mistrust and satisfaction with health care. Socio-demographic information was obtained. Mean scale scores for mistrust and satisfaction were analyzed by race. Multivariable models were used to adjust for income, education level, and distance lived from cancer care institute. RESULTS: Participation refusal rate was 38%. Of 165 eligible patients, 52 were Native American and 113 where non-Hispanic White. Native Americans expressed significantly higher levels of mistrust (p=0001) and lower levels of satisfaction (p=.0001) with health care than Whites. In multivariable analyses, race was the only factor found to be significantly predictive of higher mistrust and lower satisfaction scores. CONCLUSION: Native Americans exhibit higher medical mistrust and lower satisfaction with health care.

Establishing a patient navigator program to reduce cancer disparities in the American Indian communities of Western South Dakota: initial observations and results.

BACKGROUND: American Indians (AIs) in the Northern Plains region suffer disproportionately high cancer mortality rates compared with the general US population and with AIs from other regions in the United States. METHODS: The National Cancer Institute developed the Cancer Disparity Research Partnership to address these inequities. This initiative in Rapid City, South Dakota, attempts to lower cancer mortality rates for AIs by access to innovative clinical trials, behavioral research, and a genetic study. Patient navigation is a critical part of the program. Two navigation strategies are described: navigators at the cancer center and navigators on each reservation. A retrospective analysis was performed to determine if navigated patients (n = 42) undergoing potentially curative radiotherapy had fewer treatment interruptions compared with nonnavigated patients (n = 74). RESULTS: A total of 213 AIs with cancer have undergone patient navigation. For those undergoing cancer treatment, the median number of patient navigation interactions was 15 (range 1 to 95), whereas for those seen in follow-up after their cancer treatment, the median number of contacts was 4 (range 1 to 26). AIs who received navigation services during curative radiation treatment had on average 3 fewer days of treatment interruptions compared to AIs who did not receive navigation services during curative radiation treatment (P = .002, N = 116). CONCLUSIONS: Early findings suggest that patient navigation is a critical component in addressing cancer disparities in this population. The program has established trust with individual cancer patients, with the tribal councils, and with the general population on each of the three reservations of western South Dakota.