Current Projects Comparative Effectiveness Research on Cancer in Texas (CERCIT)
Project 1: Cancer screening in Texas PI: James S. Goodwin, MD
Project 1 is on screening for cancer. Its major new emphasis is on lung cancer screening with low dose CT (LDCT), recently approved by CMS and insurance companies. There are a number of concerns which impact the translation of an evidence-based preventive medicine activity into community practice. Prime among them for lung cancer screening is the potential harm done by invasive testing subsequent to false positive LDCTs, which might be higher in community practice than in the randomized controlled trials (RCT).
Another concern is that physicians may substitute routine diagnostic chest CTs for screening LDCT, analogous to what has occurred with screening colonoscopy. Use of a diagnostic lung CT code can circumvent the strict criteria established by CMS for reimbursement. If the CMS screening criteria are ignored, the risk/ benefit ratio is likely to be adversely altered. Our preliminary data demonstrate a substantial increase in the number of smokers receiving diagnostic lung CTs after publication of the LDCT trial in 2011.
A major question involves the implementation of the counseling/ shared decision making (SDM) visit mandated by CMS prior to LDCT screening. Who performs the SDM: the patient's PCP or the radiology facility? How is that process perceived by patients?
We will address those and related questions with two types of studies. First, we will systematically analyze Texas Medicare charge data from 2009-2019 in order to determine the patterns of counseling/ SDM and also receipt of LDCT lung cancer screening. We can examine how these patterns vary by patient characteristics. We can also assess false positive rates and downstream testing and how this varies by the radiology facility and physician network.
A second effort will be to design and implement a survey of patients who have undergone counseling/ SDM with or without subsequent LDCT screening, to explore their experience with SDM and LDCT screening. As a comparison we will also survey patients likely to qualify for LDCT screening but who had not yet received it.
These analyses will provide important information on false positive rates and subsequent testing as LDCT is implemented in the community, as well as the acceptance and effectiveness of the counseling/ SDM visit in informing patients about the benefits and risks of lung cancer screening.
Project 2: Providing Evidence for Individualized Decision Making About Chemotherapy in Older Patients PI: Sharon H. Giordano, MD, MPH
Older cancer patients face difficult choices regarding chemotherapy treatment. First, they must decide whether or not to undergo chemotherapy. Ideally, this decision will be made based on the patient's values and preferences after considering the magnitude of chemotherapy benefit, the risk and severity of toxicity, and the patient's expected remaining life span. Second, if a patient decides to receive chemotherapy, he/she may have options of different chemotherapy regimens that offer similar survival benefit but differ in toxicity. Currently, these decisions are challenging because of the lack of data on chemotherapy-related outcomes. For example, what is the interaction of individual patient characteristics and specific type of chemotherapy on a patient's functional status two years post-diagnosis?
We propose to comprehensively evaluate outcomes among a population-based cohort of older patients with colorectal, breast, and lung cancer who are treated with chemotherapy. We will assess the toxicity experienced by older patients with invasive colorectal, breast, and lung cancer during initial chemotherapy using TCR-Medicare and SEER-Medicare data, and how the toxicity varies by type of chemotherapy. We will also describe patient-reported outcomes among older cancer survivors in Texas with local and regional stage colorectal and breast cancer by surveying patients 24 months after diagnosis. We will assess how those outcomes vary by use and type of chemotherapy and by patient race/ethnicity.
We will analyze data from the Texas Cancer Registry and SEER linked to Medicare claims, and data from questionnaires that we will send to patients identified by the Texas Cancer Registry. Overall, this novel approach will greatly increase our understanding of the experiences of a diverse cohort of older cancer survivors and provide the important evidence to support individualized decision making on systemic treatments among older cancer patients.
Project 3: Assisting Cancer Patients with Surgery and Radiation Treatment Choices PI: Benjamin D. Smith, MD
Patients diagnosed with cancer frequently encounter situations where they can choose between two or more local-regional treatment strategies that confer similar survival yet differ with regard to their invasiveness and/or complication profile. However, the available evidence base often lacks the type of granular, patient-centered detail needed to determine which treatment is most likely to achieve an individual patient's desired outcome. Two common cancers in Texas are exemplary of this problem. For breast cancer, patients with early disease may choose between breast conserving surgery followed by whole breast irradiation (BCS+WBI) or mastectomy followed by breast reconstruction (without radiation). For oropharyngeal cancer, another common cancer in Texas and important source of treatment-related morbidity in working-age adults, patients with local or local-regional disease may choose between transoral surgery (TrS) (with or without radiation therapy [RT]) or RT alone. Yet for both cancers, evidence comparing patient-reported outcomes after either treatment is very limited.
The objective of this project is to develop and implement a model for gathering patient-centered evidence and making it available to support personalized, preference-sensitive decision making in cancer patients. We will conduct qualitative research to inform development of survey instruments to measure outcomes most relevant to patients, then deploy these instruments to survey large, population-based cohorts of cancer survivors, and finally apply survey findings to create a website named PROVIDE (Patient-Reported Outcome eVIDEnce calculator), that generates personalized outcome estimates and preference-sensitive comparisons of outcomes for newly diagnosed patients. To achieve our objective, we have chosen to study breast and oropharyngeal cancer as two model cancers.
We will recruit patients from diverse practice settings to participate in semi-structured interviews to identify relevant outcomes and inform survey instrument development. We will then partner with the Texas Cancer Registry to conduct large, population-based surveys of breast and oropharyngeal cancer survivors. We will use these findings to generate personalized outcome estimates in PROVIDE. Demonstrating the viability of this model will promote a novel, patient-centered paradigm for promoting personalized, preference-sensitive decision making in cancer care.
Project 4: Investigating Patient Preferences Regarding End-of-Life Care Among Cancer Patients in Texas PI: Beverly (Ashleigh) Guadagnolo, MD, MPH
Projects 1-3 investigate individual patient preferences regarding risks and benefits of cancer care from screening through survivorship. Project 4 extends this theme through the cancer care continuum by examining patient-centered preferences and decision-making factors contributing to end-of-life (EOL) cancer care. Findings from our first 5 years' research revealed that racial/ethnic minority patients and Medicaid enrollees dying of cancer in Texas disproportionately experienced low quality end-of-life (EOL care). We hypothesize that these disparities result from differences in EOL care preferences as well as mediating factors such as trust in medical professionals, health literacy, and decisional self-efficacy. The growing racial/ethnic and socioeconomic diversity of Texas make examination of this hypothesis crucial to improvements in EOL care in the state.
We will administer a previously validated survey about patient preferences for aggressiveness of EOL care to a cohort of newly diagnosed cancer patients. We will investigate variation in preferences for EOL care in Texas with respect to: age, race/ethnicity, gender, income, education, marital status, geographic variables, religiosity, health-related functional status, and cancer-related disease status (diagnosis of early stage cancer vs. advanced stage cancer). We will use previously validated instruments assessing trust in medical professionals, health literacy, and decisional self-efficacy among Texans with cancer to determine whether there are racial/ethnic or socio-economic differences in these domains and whether these domains are associated with preferences regarding EOL care.
Finally, we will perform a longitudinal cohort study of TCR decedents with advanced cancer who completed the surveys for Aims 1 and 2. We will subsequently analyze both survey and insurance claims data to ascertain whether EOL care was concordant with preferences. We will assess whether any associations between preferences and care aggressiveness are mediated by levels of trust in the medical profession, health literacy, or decisional self-efficacy.