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Forum 4: Enhancing Recruitment, Retention, and Adherence in Prevention Trials: Tricks of the Trade, chaired by Patrica A. Ganz,UCLA Johnsson Comprehensive Cancer Center, Los Angeles, CA.
Forum 5: The Role of Cancer Centers and Cooperative Groups in Advancing Cancer Prevention Research, chaired by David S. Alberts, Arizona Cancer Center, Tucson, AZ.
Forum 6: Insulin-like Growth Factors in Cancer Risk Assessment and Prevention, chaired by Michael N. Pollak, McGill University, Montreal, Canada.
Ann attended Forum 5.
Abstracts from Forum 4:
"Recruitment of minorities and the medically underserved to cancer prevention trials. The selenium and vitamin E cancer prevention trial, SELECT as a prototype", presented by Elise Donaville Cook, University of Texas, M.D. Anderson Cancer Center, Houston, TX.
"Attempts to ensure proportionate representation of minority and medically underserved participants in SELECT has been evident from study design to site selection and continues throughout conduct of this trial. Even though African American men have the highest risk of developing and dying from prostate cance, representation of this population of men in chemoprevention trials is typically less than 4%.
At 10%, SELECT is recruiting African American men at two and one-half times the rate for any other chemoprevention trial."
"A full-time national minority recruitment coordinator was hired to head this effort that included some new initiatives. Partnerships were developed with the National Black Leadership Initiative on Cancer II, NBLIC II, The Study of Tamoxifen and Raloxifene (STAR), and an African American fraternity to extend the promotion of SELECT to the African American community."
From my notes at another talk: Breast cancer survivors have been approached to bring in their husbands for this prevention trial. It has accrued almost half the needed participants in just over a year. They allotted five years for accrual, but are now confident it will be fully filled in another year or so.
"Retention in prevention settings", presented by Deborah J. Bowen, Fred Hutchinson Cancer Research Center, Seattle, WA.
"The study of retention and predictors of retention are of critical importance to current recommendations about health. Much research has been published about the study of compliance, and some of this research has helped to improve current practices in medicine and in public health."
"Issues in retention include definitions of retention and related concepts of compliance, adherence, and performances of behavior related to health. These definitions are contradictory and/or overlapping and need to be distinctly identified and used consistently across research projects. For example, if participants in a randomized trial return surveys for follow-up purposes but stop taking study medications, are they retained or adherent or performing well? Difference in conceptualizaion and measurement can lead to confusions and contradictions in findings and outcomes. Multiplie measurement modalities, such as using both self-reported and physician-reported screening behaviors, can lead to contradictory classificatin in the outcomes of retention. Another issue in retention is the lack of a population-based analysis of retention rates for behavioral or outcomes focused research and practice.
Differences in sampling and other design parameters can affect retention rates and predictors of retention. Estimates of retention to HRT regimens are often higher in clinical practice, compared with research settings, because clinical practice estimates do not use number of prescriptions written as the denominator for calculating retention rates. Many women drop out of HRT regimens before the prescriptions are even filled in clinical practice."
Some solutions:
"First, a combined focus of multilevel research, yielding comparisons of the relative importance of several variables, is needed to understand and ultimately promote retention. We must drive ourselves to better understand the complexities of retention and its promotion, in order to get at the causes of retention problems. Second, interventions and activities to promote retention should be evaluated carefully before assuming that they will improve retention. Sometimes the evaluation of specific retention aids results in surprising outcomes, such as lowered retention in certain circumstances. Finally, support for preventive activities and helpt to retain people in these activities must be available through structural changes, such as availability, promotion messages, and funding of prevention research and prevention practice."
From my experience: Some clinical trials are beginning to use advocates to greet study participants and help them acclimate. Retention is a good area to utilize advocate participation.
"Using symptom and qualtiy of life assessment in prevention trials to enhance adherence", presented by Patricia A. Ganz, UCLA School of Medicine and Public Health, Los Angeles, CA.
"In prevention trials, any symptom or side effects from a medication or supplement can play a major role in threatening adherence to the study medication. Further, non-compliance with the protocol treatment can threaten the scientific validity of the trial. Thus detailed assessment of symptoms, side effects, and quality of life (QOL) play an important role in monitoring study outcomess, as well as providing potentially important information that can enhance adherence to the study medication."
"Building a cancer prevention and control research program in a cancer center from the ground up", presented by David S. Alberts, University of Arizona, Tucson, AZ.
From my notes:
Dr. Alberts discussed the methods a cancer research facility would need to become involved in prevention research. This would include the need for dedicated staff and the cooperation of others. His facility developed an R25 Cancer Prevention and Control Training Program finding funding for the trainees and junior faculty. There are RO7 cancer prevention and control career development awards available for these same folks to apply for.
In the course of his talk, Dr. Alberts reported that aspirin is good for colon cancer recurrence prevention and that a sigmoidoscopy was not good enough follow-up.
Frank Louis Meyskens, Jr from UCI Cancer Center, Orange CA also spoke about "Building a cancer center with a strong cancer prevention control program".
Dr. Meyskens mentioned that SWOG (Southwest Oncology Group) has a strong emphasis on prevention-he was head of SWOG from 1987-1997.
Charles Coltman, Jr., Cancer Therapy and Research Center, San Antonio, TX is the current head of SWOG. He discussed the SELECT trial and mentioned that 47% of the total accrual took place in just 13 months. Since it was planned for 5 years, it seems clear the recruitment phase could be completed in just over two years.
Ann's NOTE: It is not surprising to me that a trial of non-toxic chemoprevention could accrue quickly. Many are willing to test these types of substances. Researchers and clinicians take note!
Forum 6:
"Converging population and laboratory studies regarding IGFs and cancer risk", presented by Michael N. Pollak, SMBD Jewish General Hospital-McGill University, Montreal, PQ, Canada.
" Over the past several years, prospective epidemiological studies have provided evidence that risk of colon cancer, prostate and premenopausal breast cancer is higher among individuals at the higher end of the normal range of insulin-like growth factor (IGF-1) levels than those at the lower end. Some studies also have detected an inverse relation between risk of these cancers and circulating levels of IGFB-3, the main circulating IGF binding protein."
"Ongoing research includes efforts to (1) more accurately estimate the association between IGF-1 levels and cancer risk, (2) describe interactions with other risk factors, (3) determine if there are crucial exposure periods (e.g. adolescence) at which IGF-1 level influences risk, or if life-long exposure is important, (4) add to recent data concerning SNPs and other genetic influences on expressional IGF's and IFGBP's as well as to better describe nutritional and other non-genetic influences on expression, (5) determine to what extent the known protective effects of various chemopreventative agents is attributable to their effects on IGF physiology, (6) determine if person to person variability in IGF physiology influences the efficacy of specific current approaches to cancer risk reduction and, (7) evaluate the hypothesis that interventions designed to lower IGF-1 level to the lower end of the normal range are associated with reduced risk."
"IGF-related prostate cancer risk:Recent epidemiological data from the UK and a novel risk-reduction hypothesis", presented by Jeff Holly and On Behalf of the Prodigal and Prompt Research Groups. Division of Surgery and Department of Social Medicine, University of Bristol, Bristol, UK and more.
"In the UK we have been studying population cohorts followed since the 1930s and have shown that life-long risk of cancer (particularly hormone-dependent cancers) is significantly associated with childhood nutrition and anthropometry."
"Our studies suggest that IGF-1 measurements may be of limited value for improving case detection based upon PSA measurements, but support their value for risk assessment and suggest that this might be amenable to risk reduction strategies."
"We have shown that IGFBP-3 not only modulates IGF-actions, but also has intrinsic effects on cellular response to stress, enhancing apoptosis induced by chemotherapy or radiotherapy."
"Celecoxib inhibits the functional proteomics of cancer cells by disrupting the IGF-1R/AKT pathway:Relevance to roles of NSAIDs in cancer prevention", presented by Sandra E. Dunn, University of British Columbia, Vancouver, Canada.
This study "provides a mechanistic rationale for explaining how Celecoxib (Celebrex) impacts the functional proteomics associated with IGF-IR/AKT signaling supporting the premise that this drug may be useful for the prevention of primary and secondary cancers."
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