Grant Number:	1R01CA155578-01A1 Interpret this number
Primary Investigator:	Taylor, Kathryn
Organization:	Georgetown University
Project Title:	Treatment Decisions and Patient Reported Outcomes in Low Risk Prostate Cancer
Fiscal Year:	2011

DESCRIPTION (provided by applicant): The advent of prostate-specific antigen (PSA) testing in the late 1980s has led to a dramatic rise in prostate cancer (PCa) incidence. This is a significant public health problem, as 35-40% of new prostate cancers have a low risk for progression and are unlikely to benefit from treatment, which translates into more than 75,000 U.S. men each year. In light of evidence indicating overdiagnosis and overtreatment of PCa, there has been increasing interest in active surveillance (AS) as an alternative to the active treatments (AT) of surgery and radiotherapy. AS has been proposed as a legitimate approach to minimizing the harms to quality of life (QOL) and disease-related function due to treatment of low-risk PCa (defined by PSA level < 10, Gleason score < 6, and early stage disease). Although AS is now recommended for low-risk PCa by the National Comprehensive Cancer Network and the American Urological Association, AS is considered to be underutilized among men with low-risk disease. However, there has been very little research examining non-clinical factors that affect use of AS, an important question given the public health implications for the treatment of PCa. Our specific aims are to conduct a longitudinal, prospective study among low-risk PCa patients in which we will: 1. Assess the clinical, physician- and patient-related predictors of a) the initial treatment decision of AS vs. AT and b) remaining on AS vs. switching to an AT. 2. Compare longitudinal changes in patient reported outcomes (QOL, disease specific function, treatment satisfaction) at the baseline, 6-, and 24-month assessments among those who chose AS vs. AT. We will conduct the study within the Kaiser Permanente Northern California (KPNC) HMO, which provides the significant practical advantages of a well-defined population, real-time case ascertainment, comprehensive patient reported data collected pre-treatment, and a readily accessible EMR system. Evidence from the 2010 U.S. Census indicates that 15-21% (N > 41 million) of the insured population is enrolled in a group model HMO similar to KPNC and an additional 3% (N = 8 million) receive care from the VA, indicating that the proposed study will be conducted in a setting that represents a substantial segment of the US healthcare market. We will enroll 1465 newly diagnosed, low-risk PCa patients and conduct a baseline telephone interview within 1 month post-diagnosis and two follow-up assessments at 6- and 24 -months post- baseline. Innovation centers on the inclusion of 3 sources of data: decisional and psychological patient outcomes, physician practice patterns, and biomedical and utilization EMR data, in order to fully assess the factors important to men's treatment decisions and patient reported outcomes. Our study also addresses one of the 5 top priority conditions of the IOM's report on comparative effectiveness research. Finally, the establishment of this cohort will easily lend itself to future comparisons of longer term clinical endpoints, overall health services utilization, and the development of physician- and patient-targeted interventions designed to improve decisions that may ultimately reduce the overtreatment of low-risk PCa. PUBLIC HEALTH RELEVANCE: More than 75,000 U.S. men are at risk for overtreatment each year for low-risk prostate cancer (PCa). This has resulted in an increased interest in active surveillance (AS) as an alternative to surgery and radiotherapy of low-risk PCa (defined as PCa that has a low likelihood of disease progression, based on PSA, Gleason score, and disease stage). However, AS is underutilized among men with low-risk disease. There has been very little research examining non-clinical factors (e.g., patient-related decisional and psychological factors, and physician practice patterns) that affect treatment choice and men's subsequent quality of life. These are important questions given the public health implications for reducing overtreatment of low-risk PCa.




Psychological predictors of delayed active treatment following active surveillance for low-risk prostate cancer: The Patient REported outcomes for Prostate cARE prospective cohort study.
Authors: Taylor K.L. , Luta G. , Zotou V. , Lobo T. , Hoffman R.M. , Davis K.M. , Potosky A.L. , Li T. , Aaronson D. , Van Den Eeden S.K. .
Source: Bjui Compass, 2022 May; 3(3), p. 226-237.
EPub date: 2021-12-14 00:00:00.0.
PMID: 35492225
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Selecting Active Surveillance: Decision-Making Factors for Men with a Low-Risk Prostate Cancer.
Authors: Hoffman R.M. , Lobo T. , Van Den Eeden S.K. , Davis K.M. , Luta G. , Leimpeter A.D. , Aaronson D. , Penson D.F. , Taylor K. .
Source: Medical Decision Making : An International Journal Of The Society For Medical Decision Making, 2019-10-21 00:00:00.0; , p. 272989X19883242.
EPub date: 2019-10-21 00:00:00.0.
PMID: 31631745
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Quality of life among men with low-risk prostate cancer during the first year following diagnosis: the PREPARE prospective cohort study.
Authors: Taylor K.L. , Luta G. , Hoffman R.M. , Davis K.M. , Lobo T. , Zhou Y. , Leimpeter A. , Shan J. , Jensen R.E. , Aaronson D.S. , et al. .
Source: Translational Behavioral Medicine, 2018-03-01 00:00:00.0; 8(2), p. 156-165.
PMID: 29425377
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Decision-making processes among men with low-risk prostate cancer: A survey study.
Authors: Hoffman R.M. , Van Den Eeden S.K. , Davis K.M. , Lobo T. , Luta G. , Shan J. , Aaronson D. , Penson D.F. , Leimpeter A.D. , Taylor K.L. .
Source: Psycho-oncology, 2018 Jan; 27(1), p. 325-332.
EPub date: 2017-07-13 00:00:00.0.
PMID: 28612468
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Physicians' Perceptions of Factors Influencing the Treatment Decision-making Process for Men With Low-risk Prostate Cancer.
Authors: Davis K. , Bellini P. , Hagerman C. , Zinar R. , Leigh D. , Hoffman R. , Aaronson D. , Van Den Eeden S. , Philips G. , Taylor K. .
Source: Urology, 2017 Sep; 107, p. 86-95.
EPub date: 2017-04-25 00:00:00.0.
PMID: 28454988
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Physicians' perspectives on the informational needs of low-risk prostate cancer patients.
Authors: Hagerman C.J. , Bellini P.G. , Davis K.M. , Hoffman R.M. , Aaronson D.S. , Leigh D.Y. , Zinar R.E. , Penson D. , Van Den Eeden S. , Taylor K.L. .
Source: Health Education Research, 2017-04-01 00:00:00.0; 32(2), p. 134-152.
PMID: 28380628
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Sociodemographic and Clinical Predictors of Switching to Active Treatment among a Large, Ethnically Diverse Cohort of Men with Low Risk Prostate Cancer on Observational Management.
Authors: Kelly S.P. , Van Den Eeden S.K. , Hoffman R.M. , Aaronson D.S. , Lobo T. , Luta G. , Leimpter A.D. , Shan J. , Potosky A.L. , Taylor K.L. .
Source: The Journal Of Urology, 2016 Sep; 196(3), p. 734-40.
PMID: 27091570
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Treatment Preferences for Active Surveillance versus Active Treatment among Men with Low-Risk Prostate Cancer.
Authors: Taylor K.L. , Hoffman R.M. , Davis K.M. , Luta G. , Leimpeter A. , Lobo T. , Kelly S.P. , Shan J. , Aaronson D. , Tomko C.A. , et al. .
Source: Cancer Epidemiology, Biomarkers & Prevention : A Publication Of The American Association For Cancer Research, Cosponsored By The American Society Of Preventive Oncology, 2016 Aug; 25(8), p. 1240-50.
PMID: 27257092
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