Grants and Contracts Details
A. Introduction/Background and Objectives SEER Patterns of Care/Quality of Care Studies (POC/QOC) are undertaken to examine and characterize the cancer treatment and practice patterns in different geographic areas of the United States. This POC/QOC Study shall investigate patterns of care for guideline use of biomarker testing, targeted cancer therapy, multidisciplinary care and navigation and impact of medication shortages for patients with bladder and renal cancers. The Study will also collect data on documentation of palliative care and financial discussions in the medical record. Data will be collected for patients 20 years of age or older who were diagnosed in 2019 with bladder or renal cancers. Background SEER Patterns of Care/Quality of Care Studies (POC/QOC) describe, characterize, and compare practice patterns and treatments provided for cancer in different geographic areas of the United States. POC/QOC Studies are conducted to satisfy a Congressional directive (under Public Law 100-607, Sec. 413 (a) (2) (C) adopted November 4, 1988) to the National Cancer Institute (NCI) to “assess the incorporation of state-of-the-art cancer treatments into clinical practice and the extent to which cancer patients receive such treatments and include the results of such assessment in the biennial reports…”. To satisfy the directive and to update and enhance the utility of the POC/QOC Studies, a working group including representatives from the NCI’s Divisions of Cancer Control and Population Sciences and Cancer Treatment and Diagnosis and a representative from the American Cancer Society was developed to review knowledge gaps cancer therapy dissemination and to develop priority areas for study. The group reached a consensus that a gap remains regarding factors associated with guideline use of biomarker tests and targeted therapy. Furthermore, there is limited information about the use of multidisciplinary care and navigators for patient with cancer or the impact of medication shortages on cancer treatment patterns; both important aspects of cancer care. Therefore, this year’s POC Study shall investigate patterns of care for patients with bladder and renal cancers, cancer sites often involving multidisciplinary care and, for bladder cancer, involving intermittent medication shortages. The Study will also collect data on documentation of palliative care and financial discussions in the medical record Objectives The primary objectives of the Fiscal Year 2019 NCI POC/QOC Study are to: 1) describe the use of recommended biomarker tests which shall be verified with the treating physician/physician office staff or with a unified medical record (record with all inpatient and outpatient records in a single file)and 2) describe the use of targeted therapy which shall be verified with the treating physician/physician office staff or with a unified medical record (record with all inpatient and outpatient records in a single file). Other objectives are to: 3) describe the use of adjuvant therapy, which shall be verified with the treating physician/physician office staff or with a unified medical record (record with all inpatient and outpatient records in a single file); 4) characterize the practice patterns in different communities; 5) compare the patterns of treatment (surgery, radiation therapy, systemic therapy (chemotherapy, immunotherapy, hormonal therapy, targeted therapy), and other adjuvant therapy) over time and by age, sex, race/ethnicity, and Page 1 of 11 insurance status; 6) describe comorbidities and the effect of co-morbid conditions on treatment; 7) describe treatment by hospital characteristics (i.e., for profit vs. not for profit, teaching vs. non-teaching, bed size, etc.); 8) describe the use of diagnostic tests and compare their use by demographic variables and geographic region; 9) describe the medical record documentation of multidisciplinary care and patient navigation; 10) assess the incidence of cancer recurrence; and 11) collect information on changes in cancer treatment patterns due to medication shortages. B. Approach Sample Size The sample size consists of a total of 379 patients selected from stratified random samples of the eligible cancer sites. Eligible cases will include patients 20 years of age or older who were diagnosed in 2019 with bladder cancer (176 patients) and renal cancer (203 cases). An eligible case will be the first cancer diagnosed for the patient, other than non-melanoma skin cancers such as basal cell or squamous cell carcinomas of the skin. The patient must not be diagnosed at autopsy or on death certificate only and may not be simultaneously diagnosed with a second cancer. Non-Hispanic Blacks, Hispanics, Asian/Pacific Islander and Native American/Alaskan Natives shall be oversampled to obtain more stable estimates. The patient age, stage, race/ethnicity, and sex criteria provided by the Study’s state specific sampling frame will be met for each specific cancer site. An estimate of the patients eligible for this study by stage, age at diagnosis, race-ethnicity and sex for each cancer site is included. Each table is based on 2018 data from the KCR. It should be noted that the racial composition of the Kentucky population is primarily white and any change in sample size is unlikely to yield a significant increase in the number of minorities selected for the study. African-Americans constitute the largest racial minority in the state/accounted for 8.4% of the population in 2018 according to the US Census Bureau (http://www.census.gov/quickfacts/table/KY,US/PST045218); Asians accounted for only 1.6% of the population; American Indians, Alaska Natives, Native Hawaiians and Other Pacific Islanders combined equaled only 0.4% of the population; and Hispanics or Latinos comprised 3.8% of the population. Thus, the Kentucky population is not racially or ethnically diverse. However, Kentucky has both large rural and Appalachian populations. These geographic areas have been marked by high rates of poverty and low literacy. Stratifying patients based on this geographic characteristic might provide valuable insight into variations in the patterns of care based on whether or not patients live in rural or Appalachian areas. For the current POC/QOC Study, Kentucky will be adding this additional level of stratification. Page 2 of 11
|Effective start/end date||4/5/21 → 4/4/22|
- National Cancer Institute: $211,456.00
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