Journal ArticleAcad Med · July 28, 2025
PROBLEM: The practice of evidence-based medicine relies on clinical research to develop innovations in treatment and prevention. Clinical research professionals (CRPs) are critical to the development of safe and effective health interventions that guide me ...
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Journal ArticleJ Clin Transl Sci · 2025
While clinical research intends to improve health outcomes for all, access to research participation is often limited and inequitable. Geographic proximity is a recognized barrier, thus, systemic infrastructure solutions through federal programs including ...
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Journal ArticleJ Clin Transl Sci · 2025
The potential for physicians, clinicians, and health professionals to contribute to the advancement of medical therapies through clinical research is significant. Yet, a lack of exposure to, or practical training in, the conduct of clinical research can in ...
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Journal ArticleJournal of clinical and translational science · January 2025
BackgroundClinical research professionals (CRPs) are essential members of research teams serving in multiple job roles. However, recent turnover rates have reached crisis proportions, negatively impacting clinical trial metrics. Gaining an underst ...
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Journal ArticleJournal of clinical and translational science · January 2025
IntroductionHigh workforce turbulence has plagued clinical research, becoming intensified during the COVID-19 pandemic, especially for patient-facing workers. In a time of great uncertainty and risk among healthcare workers, researchers included, ...
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Journal ArticleJ Clin Transl Sci · 2025
Current evidence underscores a need to transform how we do clinical research, shifting from academic-driven priorities to co-led community partnership focused programs, accessible and relevant career pathway programs that expand opportunities for career de ...
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Journal ArticleJ Clin Transl Sci · 2025
The Duke Research Equity and Diversity Initiative (READI) was established in 2021 to engage Durham and surrounding communities in clinical research and build capacity to promote equitable access to research participation. Within READI, a voucher program wa ...
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Journal ArticleContemp Clin Trials Commun · December 2024
BACKGROUND: eSource software that transfers patient electronic health record data into a clinical trial electronic case report form holds promise for increasing data quality while reducing data collection, monitoring and source document verification costs. ...
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Journal ArticleJ Imaging Inform Med · October 2024
De-identification of DICOM images is an essential component of medical image research. While many established methods exist for the safe removal of protected health information (PHI) in DICOM metadata, approaches for the removal of PHI "burned-in" to image ...
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Journal ArticleStat (Int Stat Inst) · June 2024
Collaborative quantitative scientists, including biostatisticians, epidemiologists, bio-informaticists, and data-related professionals, play vital roles in research, from study design to data analysis and dissemination. It is imperative that academic healt ...
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Journal ArticleFrontiers in Pharmacology · January 1, 2024
Jobs for clinical research professionals (CRPs) have grown increasingly complex over the past 20+ years. This is due largely to additional administrative burden for investigators, study teams, sponsors, Clinical Research Organizations (CROs), and sites, pa ...
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Journal ArticleClinical trials (London, England) · October 2023
The clinical and translational research enterprise is recognized by many as the "evidence generation system." While there have been several calls to revolutionize this enterprise to more effectively deliver the fruits of biomedical science to patients and ...
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Journal ArticleJournal of clinical and translational science · January 2023
Quality clinical research is essential for health care progress and is the mission of academic health centers. Yet ensuring quality depends on an institution's ability to measure, control, and respond to metrics of trial performance. Uninformed clinical re ...
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Journal ArticleJournal of clinical and translational science · January 2023
In 2016, Duke reconfigured its clinical research job descriptions and workforce to be competency-based, modeled around the Joint Taskforce for Clinical Trial Competency framework. To ensure consistency in job classification amongst new hires in the clinica ...
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Journal ArticleFrontiers in Medicine · January 1, 2023
Over the past 7 years, Duke has implemented competency-based job classifications for clinical research professionals (CRPs) with a defined pathway for career advancement. The workforce is defined specifically as the collection of staff employed across the ...
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Journal ArticleJournal of Clinical and Translational Science · June 3, 2022
Background: Identification of evidence-based factors related to status of the clinical research professional (CRP) workforce at academic medical centers (AMCs) will provide context for National Center for Advancing Translational Science (NCATS) policy cons ...
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Journal ArticleJ Clin Transl Sci · 2022
BACKGROUND: Adequate equitable recruitment of underrepresented groups in clinical research and trials is a national problem and remains a daunting challenge to translating research discoveries into effective healthcare practices. Engagement, recruitment, a ...
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Journal ArticleJournal of Research Administration · January 1, 2020
Aligning job descriptions at Duke University Schools of Medicine and Nursing with the Joint Task Force for Clinical Trial Competencies ( JTFCTC) spurred additional related activities—namely, establishing professional pathways and career ladders for clinica ...
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Journal ArticleCancer causes & control : CCC · April 2019
PurposeRural cancer survivors (RCS) have poorer health outcomes and face multiple challenges-older age, and limited transportation, education, income, and healthcare access. Yet, RCS are understudied. The Reach-out to ENhancE Wellness(RENEW) trial ...
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Journal ArticleContemporary clinical trials communications · December 2017
BackgroundPoor diet and insufficient physical activity are strongly associated with an increased risk of several cancers. Preclinical studies suggest that lifestyle modifications may exert favorable effects on tumor biology. Randomized controlled ...
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Journal ArticleSupport Care Cancer · August 2017
PURPOSE: Few trials have aimed to promote diet and exercise behaviors in both cancer survivors and their family members and examine their associations with weight-related outcomes. We conducted a secondary analysis to examine associations between change in ...
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Journal ArticleJ Geriatr Oncol · November 2016
OBJECTIVES: To characterize factors contributing to physical resilience in older cancer survivors, as demonstrated by resistance to decline or recovery (resilience). MATERIALS AND METHODS: We conducted a secondary analysis of data from a randomized control ...
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Journal ArticleContemporary clinical trials · May 2016
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Clinical research activities at academic medical centers are challenging to oversee. Without effective research administration, a continually evolving set of regulatory and institutional requirements can divert investigator and study team attention away fr ...
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Journal ArticleCancer · December 15, 2015
BACKGROUND: The number of older cancer survivors is increasing as more adults survive to older ages. The objectives of this study were to examine trajectories of physical activity (PA) and physical function (PF) over a 2-year lifestyle counseling study and ...
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Journal ArticleJournal of transcultural nursing : official journal of the Transcultural Nursing Society · September 2015
BackgroundMalnutrition is an urgent problem in the developing world, especially for children under 5 years of age. The article describes the utilization of a standard of practice designed to prevent illness in a malnourished, under-5 indigenous po ...
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Journal ArticleBiotech Histochem · April 2015
In vitro bioassay has been used extensively to test the effects of culturing cancer cells in sera from humans participating in dietary interventions, i.e, studies of modified intake of nutrients for the purpose of reducing cancer risk or progression. It ha ...
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Journal ArticleAm J Hematol · March 2015
The outcomes of children with congenital hemolytic anemia (CHA) undergoing total splenectomy (TS) or partial splenectomy (PS) remain unclear. In this study, we collected data from 100 children with CHA who underwent TS or PS from 2005 to 2013 at 16 sites i ...
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Journal ArticleClin Transl Sci · February 2015
The Food and Drug Administration Amendments Act of 2007 (FDAAA 2007, US Public Law 110-98) mandated registration and reporting of results for applicable clinical trials. Meeting these registration and results reporting requirements has proven to be a chall ...
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Journal ArticleCancer · January 2015
BackgroundThe health benefits of diet and exercise interventions for cancer survivors are well documented. However, little is known regarding demographic and medical predictors of survivors' willingness to participate in diet and exercise interven ...
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Journal ArticleAnn Behav Med · October 2014
BACKGROUND: Diet and exercise interventions for cancer survivors result in health benefits; however, few studies have examined health outcomes in relation to adherence. PURPOSE: We examined associations between adherence to components of a diet-exercise in ...
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Journal ArticleCancer · August 15, 2014
BACKGROUND: Few studies to date have used the cancer diagnosis as a teachable moment to promote healthy behavior changes in survivors of cancer and their family members. Given the role of obesity in the primary and tertiary prevention of breast cancer, the ...
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Journal ArticleMed Sci Sports Exerc · July 2014
UNLABELLED: While moderate- to vigorous-intensity physical activities (MVPA) confer the greatest health benefits, evidence suggests that light-intensity activities are also beneficial, particularly for older adults and individuals with moderate to severe c ...
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ConferenceProceedings 2014 IEEE International Conference on Healthcare Informatics Ichi 2014 · March 2, 2014
Academic Medical Centers continually struggle with clinical trials study management. A common approach is the implementation of a Clinical Trials Management System. However, integration of the Clinical Trials Management System with the health system's Elec ...
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Journal ArticleJ Sex Med · March 2014
INTRODUCTION: Despite the ubiquity of 1-month recall periods for measures of sexual function, there is limited evidence for how well recalled responses correspond to individuals' actual daily experiences. AIM: To characterize the correspondence between dai ...
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Journal ArticleIntegr Cancer Ther · May 2013
BACKGROUND: Cancer treatment -related side effects may have a negative impact on quality of life among cancer survivors and may limit participation in physical activity (PA). HYPOTHESIS: Cancer-specific concerns will be reduced throughout a 10-month diet a ...
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Journal ArticlePsychooncology · April 2013
BACKGROUND: This study examined whether changes in self-efficacy explain the effects of a mailed print intervention on long-term dietary practices of breast and prostate cancer survivors. The relationship between change in self-efficacy and long-term physi ...
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Journal ArticleJ Med Food · April 2013
Enterolactone and enterodiol, mammalian lignans derived from dietary sources such as flaxseed, sesame seeds, kale, broccoli, and apricots, may impede tumor proliferation by inhibiting activation of nuclear factor kappa B (NFκB) and vascular endothelial gro ...
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Journal ArticleClin Transl Sci · December 2012
Collecting and managing data for clinical and translational research presents significant challenges for clinical and translational researchers, many of whom lack needed access to data management expertise, methods, and tools. At many institutions, funding ...
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Journal ArticleNutrition in clinical practice : official publication of the American Society for Parenteral and Enteral Nutrition · October 2012
A number of epidemiological studies have investigated associations between various phytochemicals and cancer risk. Phytoestrogens and carotenoids are the two most commonly studied classes of phytochemicals; phytosterols, isothiocyanates, and chlorophyll al ...
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Journal ArticleSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · October 2012
PurposeFew studies have investigated long-term effects of physical activity (PA) interventions. The goal of this study was to evaluate whether or not increased levels of moderate to vigorous physical activity (MVPA) were maintained by cancer survi ...
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Journal ArticlePediatr Blood Cancer · July 15, 2012
BACKGROUND: Clinical outcomes of children with sickle cell disease (SCD) who undergo total or partial splenectomy (PS) are poorly defined. The purpose of this retrospective study was to initiate an Internet-based registry to facilitate analysis of clinical ...
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Journal ArticleJ Clin Oncol · July 1, 2012
PURPOSE: Diet and exercise interventions have been tested in cancer survivors as a means to reduce late effects and comorbidity, but few have assessed adherence and health outcomes long term. METHODS: Between July 2005 and May 2007, the Reach Out to Enhanc ...
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Journal ArticleJ Acad Nutr Diet · June 2012
BACKGROUND: Older adult cancer survivors are at greater risk of cancer recurrence and other comorbidities that can be prevented through improved diet and weight management. The tertiary prevention needs of rural-dwelling survivors can be even greater, yet ...
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Journal ArticlePsychooncology · January 2012
OBJECTIVE: Cancer coping styles have been associated with several cancer-related outcomes. We examined whether baseline lifestyle behaviors differed between cancer survivors with fatalistic vs fighting-spirit coping styles, and whether there was differenti ...
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Journal ArticlePLoS One · 2012
Previous observational studies have reported associations between prostate cancer and alpha-linolenic acid (ALA). However, few investigations have been able to study this relationship prospectively and in well-controlled settings. Moreover, no studies have ...
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Journal ArticleJ Cancer Surviv · December 2011
INTRODUCTION: Despite proven benefits of regular physical activity, estimates indicate that few cancer survivors meet physical activity guidelines. The purpose of this paper is to identify and compare exercise barriers among cancer survivors, both cross-se ...
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Journal ArticleJ Am Diet Assoc · December 2011
BACKGROUND: Cancer survivors are at increased risk for secondary cancers and other diseases. Healthy dietary practices may improve cancer survivors' health and well-being. OBJECTIVE: The durability of the effects of the FRESH START intervention, a program ...
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Journal ArticleCancer Prev Res (Phila) · October 2011
Diet, nutritional status, and certain dietary supplements are postulated to influence the development and progression of prostate cancer. Angiogenesis and inflammation are central to tumor growth and progression, but the effect of diet on these processes r ...
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Journal ArticleJ Am Geriatr Soc · November 2009
Currently, there are about 7 million cancer survivors in this country aged 65 and older, and this number is expected to increase rapidly, given trends toward aging and improvements in early detection and treatment. Unfortunately, cancer survivors are at ri ...
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Journal ArticleCancer · September 1, 2009
BACKGROUND: Older cancer survivors are at increased risk for secondary cancers, cardiovascular disease, obesity, and functional decline and, thus, may benefit from health-related interventions. However, to the authors' knowledge, little is known regarding ...
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Journal ArticleMed Sci Sports Exerc · June 2009
PURPOSE: The primary study aim was to evaluate associations of estimated weekly minutes of moderate-to-vigorous-intensity exercise from self-reports of the telephone-administered 7-Day Physical Activity Recall (7-Day PAR) with data captured by the RT3 tria ...
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Journal ArticleJAMA · May 13, 2009
CONTEXT: Five-year survival rates for early stage colorectal, breast, and prostate cancer currently exceed 90% and are increasing. Cancer survivors are at greater risk for second malignancies, other comorbidities, and accelerated functional decline. Lifest ...
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Journal ArticlePsychooncology · April 2009
OBJECTIVE: Cure rates for cancer are increasing, especially for breast, prostate, and colorectal cancer. Despite positive trends in survivorship, a cancer diagnosis can trigger accelerated functional decline that can threaten independence, reduce quality-o ...
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Journal ArticleCancer Epidemiol Biomarkers Prev · December 2008
BACKGROUND: Prostate cancer affects one of six men during their lifetime. Dietary factors are postulated to influence the development and progression of prostate cancer. Low-fat diets and flaxseed supplementation may offer potentially protective strategies ...
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Journal ArticleJ Health Psychol · November 2008
This study examined among recently diagnosed breast and prostate cancer survivors (N = 678) associations between worry about a future diagnosis of heart disease or cancer and hypothetical and actual adherence to exercise and dietary guidelines. Greater wor ...
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Journal ArticlePsychooncology · October 2008
OBJECTIVE: This study examined change in self-efficacy as a mediator of the effects of a mailed print intervention on the dietary and exercise practices of newly diagnosed breast and prostate cancer survivors. METHOD: A total of 543 breast and prostate can ...
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Journal ArticleJ Am Geriatr Soc · October 2008
OBJECTIVES: To determine whether elderly people who meet national guidelines have higher physical function (PF) scores than those who do not and the effect on functional trajectory when physical activity (PA) levels change from above to below this threshol ...
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Journal ArticleJ Cancer Surviv · September 2008
INTRODUCTION: The purpose of the present study was to assess dietary supplement use and its association with micronutrient intakes and diet quality among older (>or=65 years), long-term survivors (>or=5 years post-diagnosis) of female breast, prostate, and ...
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Journal ArticleCancer Epidemiol Biomarkers Prev · May 2008
Participant accrual to research studies is a challenge; oftentimes, advertisements are used to supplement cases ascertained through clinic caseloads and cancer registries. It is unknown, however, if cases ascertained through these two sources differ. In th ...
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Journal ArticleClin Breast Cancer · February 2008
PURPOSE: Patients with breast cancer on adjuvant chemotherapy can experience weight gain and concurrent losses in muscle mass. Exercise interventions can prevent these changes, but time and travel pose barriers to participation. The Survivor Training for E ...
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Journal ArticleClin Trials · 2008
BACKGROUND: The time between the diagnosis of cancer and a planned definitive surgical procedure offers a strong and direct approach for assessing the impact of interventions (including lifestyle interventions) on the biology of the target tissue and the t ...
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Journal ArticleOncol Nurs Forum · January 2008
PURPOSE/OBJECTIVES: To determine childhood cancer survivors' barriers to increasing exercise and consuming less fat and more fruits and vegetables, whole grains, and calcium-rich foods. DESIGN: Mailed survey. SETTING: Cases from a comprehensive cancer cent ...
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Journal ArticleJ Clin Oncol · July 1, 2007
PURPOSE: Cancer survivors are at increased risk for cardiovascular disease, diabetes, osteoporosis, and second primary tumors. Healthful lifestyle practices may improve the health and well-being of survivors. The FRESH START trial tested the efficacy of se ...
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Journal ArticleCurr Top Nutraceutical Res · 2007
Flaxseed is a rich source of lignan and has been shown to reduce androgen levels in men with prostate cancer. Polycystic ovarian syndrome (PCOS), a common endocrine disorder among women in their reproductive years, also is associated with high levels of an ...
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Journal ArticleThe Journal of nutrition · January 2007
In the world today, there are roughly 25 million cancer survivors. Although the increasing numbers of survivors testifies to the success of early detection and treatment, there is a downside. Cancer survivors are at increased risk for second cancers, other ...
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Journal ArticleJ Clin Oncol · July 20, 2006
PURPOSE: Declines in physical functioning (PF) among elderly cancer patients threaten quality of life and the ability to maintain independence. Adherence to healthy lifestyle behaviors may prevent functional decline. PATIENTS AND METHODS: Project Leading t ...
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Journal ArticleComput Inform Nurs · 2005
Tailored health information is important for generating patient-specific recommendations in clinical decision support systems and for crafting health education materials that are specifically customized to a patient. Many previous attempts to generate tail ...
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Journal ArticleInt J Behav Nutr Phys Act · October 29, 2004
BACKGROUND: Functional decline threatens independent living and is common among individuals diagnosed with cancer, especially those who are elderly. The purpose of this study was to explore whether dietary and exercise practices are associated with physica ...
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Journal ArticleJ Am Diet Assoc · October 2004
Brief screening instruments can roughly characterize individual behavior and target those most in need of change. However, the level of agreement between abbreviated and full-scale instruments is often unknown. We determined agreement between a brief scree ...
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Journal ArticleControl Clin Trials · April 2003
The U.S. population is aging, bringing with it an increased prevalence of chronic disease and concomitant declines in physical function. The risk of developing cancer increases significantly with age, and functional decline is much more likely once a cance ...
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Journal ArticleMed Sci Sports Exerc · March 2003
PURPOSE: FRESH START is a randomized controlled trial that will test whether a personally tailored, distance-medicine-based program will increase exercise and fruit and vegetable consumption, and decrease fat intake of individuals recently diagnosed with b ...
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