Special Study Description
Special Study Description
Comparative Effectiveness Research (CER)
- In response to the need for data to support comparative effectiveness, or patient-centered outcomes, research, the Agency for Healthcare Research and Quality and the CDC’s National Program of Cancer Registries (NPCR) developed this special data enhancement project to help answer specific CER questions.
- Ten specialized cancer registries were funded as CDC-NPCR Specialized Registries to collect detailed treatment and biomarker data for breast, colon, and rectal cancers as well as chronic myeloid leukemia cases diagnosed in 2011 for Comparative Effectiveness Research. They also established sustainable procedures to gather more information on all cancer cases, including co-morbidities, height, weight, smoking status, and detailed staging. The cancer incidence data are linked to census tract-level socioeconomic status variables so researchers can describe detailed outcomes at the neighborhood level. Outcomes from the CER activities will include a dataset to be used for comparative effectiveness and other research.
- The second phase of this study, which is funded by PCORI through a contract with ICF Macro, Inc., will collect data on recurrence and progression, as well as additional information for colorectal and breast cancer patients included in the CER project.
Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR)
- The CEASAR Study is a three-year project funded by the Agency for Healthcare Research and Quality (AHRQ) through a grant to the Vanderbilt University Medical Center and is subcontracted to the LTR at LSUSHC.
- Its purpose is to learn about the effectiveness of contemporary surgical and radiation techniques for localized prostate cancer in terms of patient-reported outcomes, including side effects and complications of treatment.
- The study is occurring at six research centers around the country. Over 900 Louisiana men diagnosed with localized prostate cancer in 2011 and 2012 were enrolled within four months of diagnosis through the registry’s rapid case ascertainment system, and all six research centers enrolled more than 3,600 men. The initial phase of the study involved a baseline survey, a six-month follow-up survey, and a twelve-month follow-up survey.
- Medical records were abstracted for study participants to obtain additional information.
- The second phase of the study, funded by the Patient Centered Outcomes Research Institute (PCORI) and AHRQ, involves three- and five-year follow-up surveys in 2013-2018.
Measuring Your Health (MY-Health) Study
- The MY-Health Study is funded by the National Institutes of Health at four research centers around the country, including Louisiana. The coordinating center is the Georgetown University’s Lombardi Comprehensive Cancer Center.
- The study objective is to learn about the experiences of individuals in different communities who have been diagnosed with and treated for cancer, determine the best questions that healthcare providers and researchers should ask to understand the physical and emotional experiences of cancer patients, and improve our understanding of the quality of life after a cancer diagnosis.
- Four NCI-SEER registries have recruited a total of about 5,600 patients who were diagnosed with cancers of the breast, colon/rectum, corpus uterus, cervix, prostate or lung or non-Hodgkin lymphoma from 2010 through 2012, using the registries’ rapid case ascertainment systems. Louisiana recruited about 1,100 participants.
- Participants completed an initial survey 6-9 months after their cancer diagnosis and a follow-up survey six months after the initial survey.
- Medical records were re-abstracted for a random sample of participants who completed both surveys.
SEER Patterns of Care (PoC)
- The SEER PoC studies are conducted annually to comply with the Congressional Directive to the NCI under Public Law 100-607 to “assess the incorporation of state-of-the-art cancer treatment into clinical practice and the extent to which cancer patients receive such treatment.” The LTR has participated in the SEER PoC studies since 2002, and Louisiana data have been included in numerous publications. These studies assess the dissemination of cancer treatments conforming to national recommendations and identify factors contributing to disparities in the quality of cancer care. Every year, the study selects certain cancers for which registries collect additional treatment information.
Early Case Capture (ECC) of Pediatric and Young Adult Cancers
- In 2008, the US Congress signed into law the Caroline Pryce Walker Conquer Childhood Cancer Act. Through it, the ECC project was initiated to develop a repository of childhood cancer that is representative of the US population for the surveillance, clinical, and research communities. The LTR responded by enhancing its routine cancer surveillance activities and building sustainable infrastructure for identifying new pediatric and young adult cancer cases (ages 0-19) within 30 days of diagnosis. Clinical diagnoses of children via imaging sources is of particular interest to the LTR and the CDC in this project, as many tumors are identified before surgical specimens can be obtained.
African American Cancer Epidemiology Study (AACES)
- This study, funded by the National Cancer Institute through a grant to the Duke Cancer Institute, seeks to better understand the causes of ovarian cancer in African-American women. Although ovarian cancer is the fifth most common cause of death from cancer in women, this is the first study to focus on ovarian cancer in African Americans. This investigation is important because the survival of African Americans with ovarian cancer is worse than that of white women.
- Eligible participants will be contacted by the Duke Cancer Institute. Those who agree to participate will complete a telephone interview and a diet survey and will give a small blood sample. Target enrollment for the study is 1000 African-American women with a recent diagnosis of ovarian cancer and 1000 women who have never had the disease.
- With the introduction of the HPV vaccine, baseline information on precancerous cervical lesions is required in order to assess the impact of the vaccine on the disease burden. A surveillance project in four cancer registries (Kentucky, Louisiana, Michigan and Los Angeles) was developed to collect data on CIN III to estimate the incidence of precancerous cervical lesions and to evaluate the feasibility of routine surveillance of other precancerous lesions using the existing cancer registry infrastructure.
Young Breast Cancer Survivors (YBCS)
- The Young Breast Cancer Survivors Study is funded by the Centers for Disease Control and Prevention (CDC) and will include about 100 residents of New Orleans and Baton Rouge who were under the age of 45 at the time of their breast cancer diagnosis. Other eligible participants include 50 family members and 25 service providers for women younger than 45 at diagnosis. Eligible women are asked to complete a survey indicating how much certain physical, marital, sexual, and other issues apply to them since their cancer diagnosis. Family members and service providers will be asked to indicate how much cancer has affected their loved ones or patients. The goal of the study is to assess the needs of young breast cancer survivors in order to help plan appropriate services. For more information about the program and resources available to young breast cancer survivors, please visit www.survivedat.org.
Osteosarcoma Surveillance Study
- This study, conducted by RTI International on behalf of Eli Lilly and Company, is investigating the safety of the drug Forteo. The purpose of the study is to learn more about factors that may be related to the development of osteosarcoma or similar cancers. All patients who reside in Louisiana and have been diagnosed with osteosarcoma or a similar cancer between January 1, 2007, and September 30, 2018, and are 40 years of age or over are asked to take part in this study. The LTR will provide eligible cases to RTI, which will administer a 25-30 minute phone survey.
The LTR also participates in the following linkage studies:
Linkage Study for the Forteo Post-Approved Osteosarcoma Surveillance
- The purpose of this study is to link the LTR data with the Forteo Patient Registry data for an estimation of the incidence of osteosarcoma in patients who received Forteo treatment. This linkage takes place once a year from 2010 to 2022.
American Cancer Society Cancer Prevention Study II
- This study examines the impact of environment and lifestyle factors on cancer etiology in a large group of American men and women. The LTR links its data with the study cohort every 2-3 years.
NCI-American Association of Retired People (AARP) Diet and Health Study
- This prospective study aims to elucidate the impact of diet and lifestyle factors on the likelihood of developing or dying from cancer. It follows a cohort of AARP members by repeated questionnaires and then links its data with state cancer registry data for cancer outcomes.
Black Women’s Health Study
- The purpose of this study is to identify and evaluate causes and preventions of cancers and other serious illnesses among African-American women. The LTR has performed a linkage with this study cohort annually or biennially since 2007.
Southern Community Cohort Study
- This NCI-funded study addresses many unresolved questions about the root causes of chronic disease health disparities, with its findings expected to help prevent and reduce the burden of disease among all populations.
SEER Medicare Linkage Project
- This project links SEER data with data from the Centers for Medicare and Medicaid Services to create a unique population-based source of information that can be used for analyzing patterns of care for cancer patients aged 65 years and older. The linkage is updated every three years.
Cancer Incidence Study of Shell Manufacturing Employees in Louisiana
- This study will determine the cancer incidence, from 1983 to 2010, of employees at two Shell facilities and compare their cancer risk with that of the South Louisiana general population. Because employees at an industrial complex potentially experience far more exposure to chemicals and chemical emissions than the general population, examination of such employee health experience offers an opportunity to determine whether their cancer risk is higher than the general population and whether working experience (e.g., years of employment) is associated with the risk.
The LTR previously participated in these studies:
North Carolina-Louisiana Prostate Cancer Project (PCaP)
- Prostate cancer patients from North Carolina and Louisiana were enrolled in the PCaP study, which was funded by the Department of Defense, to develop effective therapies for advanced prostate cancer as well as techniques to distinguish between indolent and aggressive disease. Eligible men participated in home visits, which included one meeting in which questions about diet, lifestyle, and health care were asked. Trained staff members measured height, weight, and hips and waist size and collected samples of urine, toenails, fat, and blood.
Quality of Life in Prostate Cancer Project (QPCAP)
- The PCaP study led to a follow-up study to identify pre-diagnostic variables that may affect the long-term health-related quality of life of men diagnosed with prostate cancer. QPCaP’s primary hypothesis is that racial differences in long-term quality of life for prostate cancer survivors are the results of racial differences in pre-diagnosis health-related behaviors, socioeconomic status, and healthcare-seeking behaviors and beliefs.
Adolescent and Young Adult Health Outcome and Patient Experience (AYA HOPE) Study
- Compared with younger and older cancer patients, adolescents and young adults (ages 15 to 39) with cancer have experienced little or no improvement in cancer survival for decades. This research sought to identify factors that contribute to the poorer survival in AYAs. In 2007, the National Cancer Institute (NCI) funded seven population-based registries including the Louisiana Tumor Registry to conduct a preliminary study to test the feasibility of contacting AYAs to ask about their experiences in accessing care, impressions of the quality of care received, and health outcomes in the first 14 months following cancer diagnosis.
- AYA patients included in the study had been diagnosed with Hodgkin lymphoma, non-Hodgkin lymphoma, acute lymphoblastic leukemia, germ cell cancer, or sarcoma between July 1, 2007, and October 31, 2008. In addition to conducting patient surveys, registry staff re-abstracted medical records to obtain detailed information on cancer diagnosis and treatments.
- After successfully completing the initial survey, the LTR received additional funding from the NCI to conduct a follow-up survey to collect data (approximately 24 months post-diagnosis) on side effects of therapy, changes in employment/student status, family planning and fertility issues, supportive care needs, recurrence of the initial cancer, and ongoing health-related quality of life.
CDC Breast and Prostate Cancer Data Quality and Patterns of Care Study
- This study involved researchers from the CDC and seven states and is the National Program of Cancer Registries’ most comprehensive patterns of care study.
- The study objectives included examining patterns of first-course treatment received by prostate cancer and female breast cancer patients, the extent to which that care is concordant with nationally recognized treatment guidelines, and how patterns of cancer care vary by patient, provider, and health system.
- Routinely collected registry data were supplemented by re-abstracting hospital records and obtaining information about adjuvant treatment and comorbidities from physicians and outpatient facilities.