The Cancer Control & Survivorship (CCS) Program consists of a highly productive multi-disciplinary team affiliated with seven different departments/divisions within the institution. The CCS Program is co-led by Melissa Hudson, MD and Les Robison, PhD, whose combined expertise and experience encompass clinical- and population-based cancer research. St. Jude investigators have contributed to the understanding of many aspects of cancer prevention and control among pediatric and adolescent populations. Examples of the major accomplishments in CCS research include (1) the understanding of clinical follow-up and assessment of outcomes among long-term survivors of childhood cancer seen with the St. Jude After Completion of Therapy (ACT) Program; (2) observational and interventional research on tobacco use among childhood cancer survivors; and (3) the conduct of large-scale cohort studies to characterize the occurrence and risk profiles for long-term late effects of therapy.
The goals of the CCS Program are to conduct cancer-related research on outcomes and interventions among pediatric and adolescent populations. In addition the Program aims to develop a focus of research in the epidemiology/etiology of pediatric malignancies. These research activities form the basis for a program of highly productive and innovative research at St. Jude, with the ultimate goal of significantly impacting upon the morbidity and mortality associated with childhood cancer. To accomplish the goals of the CCS Program the following scientific objectives will be pursued: (1) to describe the occurrence and pathogenesis of physiological and psychological long-term outcomes associated with the diagnosis and successful treatment of cancer during childhood and adolescence; (2) to develop and test innovative interventions, suitable for widespread dissemination, designed to prevent acute and long-term complications of treatment and improve quality of life; and (3) to identify genetic and environmental risk factors for pediatric malignancies.
A significant strength of the CCS Program is its outcomes research focus, which has a strong link to the ACT Program at St. Jude. The ACT Program is uniquely positioned to generate new knowledge regarding the long-term impact of cancer and associated therapy among the growing population of survivors treated at St. Jude. With the institutional policy of bringing patients who have completed therapy back to the institution on at least an annual basis, St. Jude is able to achieve a level of long-term clinical follow-up that permits scientifically sound research in long-term survivors. This allows St. Jude to conduct state-of-the-art clinical assessments of a larger and more representative population of cancer survivors than can be achieved in most clinical settings. Moreover, the commitment has been made to significantly expand beyond the ACT Program by establishing a new research protocol (i.e., St. Jude Lifetime Cohort Study, SJLIFE) consisting of an initial cross-sectional study design to clinically evaluate the more than 4000 cancer survivors discharged from St. Jude care, followed by the establishment of an extended follow-up cohort of these survivors who will be invited to return to St. Jude on a recurring basis to prospectively participate in clinically-based research. Creation of a lifetime cohort of childhood cancer survivors treated at St. Jude Children’s Research Hospital will provide a singular research opportunity to evaluate, within a clinical setting, the long-term outcomes in aging adults surviving pediatric cancer, while identifying treatment-, genetic-, demographic-, and psychological/psychosocial/behavioral-related predictors of adverse health outcomes.
With the recruitment of Dr. Robison, the NCI-funded Childhood Cancer Survivor Study (CCSS) has been relocated to St. Jude, after 11 years at the University of Minnesota. Having CCSS at St. Jude represents a new level of research activity, particularly with the expansion of the cohort to include approximately 14,800 additional five-year survivors diagnosed and treated between1987-99. An additional new aspect being development within the CCS Program is research directed toward non-cancer populations to modify health-related behaviors during childhood, which may impact cancer risk later in life. To this end, with the recruitment of Robert Klesges, the Girls Health Enrichment Multisite Study (GEMS), a randomized intervention study for weight reduction in African-American teen-age girls, has now been relocated to St. Jude.
To aid in the expansion of cancer prevention and control research, St. Jude is currently establishing a formal consortium consisting of six institutions to participate in the conduct of interventional research. The St. Jude Consortium for Interventional Research will design and test randomized clinical trials of intervention strategies addressing topics of supportive care, health promotion/screening, health status, health behaviors, and chemoprevention. St. Jude will facilitate the activities of the consortium by providing support for institutionally-based study coordinators and centralized clinical trials data management and statistical analysis. Members of the St. Jude consortium will design innovative intervention strategies, seek and secure external peer-reviewed funding, develop and coordinate protocols for study conduct, and reporting. The focus of the research to be conducted by the consortium will be randomized studies of modest size (e.g., typically less than 200 patients) that can accrue study subjects within a 1-2 year period, and require minimal follow-up. The primary outcomes to be tested within these trials will relate to questions of feasibility with reliance upon intermediate outcomes addressing efficacy. In this way, the St. Jude Consortium for Interventional Research can serve as a source for interventions that are feasible and indicate efficacy, which can then be more fully tested within other venues (e.g., Children’s Oncology Group or other consortia).
To substantially broaden the activities of the CCS Program, the commitment has been made to establish a more formal program in epidemiologic/etiologic research at St. Jude. While the primary focus of the epidemiology research program will be on molecular etiology, there will be a blend of laboratory and non-laboratory-based investigations. It is envisioned that the program of epidemiologic research will involve collaborations with existing faculty whose research programs focus on the occurrence of second malignancies among cancer survivors as well as opportunities to capitalize on resources and programs already established in the International Outreach Program. Specifically, to conduct hypothesis-driven research within regions of the world with excessively high rates of certain childhood cancers and/or unique environmental exposures.
To further support the CCS research activities at St. Jude, we have established a Clinical and Survey Research Support Facility (CS-RSF) within the Department of Epidemiology and Cancer Control. This support facility is an institutionally-supported resource available to faculty and staff engaged in clinical and/or survey research. The CS-RSF provides assistance with establishment and management of research databases to investigator specifications. These databases incorporate customized data validation procedures, and utilize advanced applications for web-based data entry, as well as, optical character recognition applications to scan, verify and record data. The CS-RSF also develops and produces paper-based and electronic data collection forms and other instruments, conducts telephone interviews using computer-assisted telephone interviewing (CATI), and maintains a searchable electronic library of case report form collections. Other capabilities of the Survey Research Support Facility include tracing of subjects lost-to-follow-up, recruitment and retention of study subjects, retrieval of medical record information, and data abstraction/coding.