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Generating critical patient-centered information for decision making in localized prostate cancer
Investigator (PI): Penson, David
Performing Organization (PO): (Current): Vanderbilt University Medical Center, Department of Urologic Surgery / (615) 343-1529
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2013
Final Year: 2018
Record Source/Award ID: PCORI/CE-12-11-4667
Funding: Total Award Amount: $2,007,390
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Prostate cancer (PCa) is the most common solid tumor and the second leading cause of cancer death among American men. While surgery, radiation, and observation have all been deemed appropriate therapies for localized PCa, many questions remain unanswered. In fact, AHRQ's 2008 evidence report on the comparative effectiveness of therapies for localized PCa concluded that "no one therapy can be considered the preferred treatment for localized PCa." The report called for high-quality, prospective cohort studies that identify men at the time of diagnosis and collect comprehensive patient, tumor, and treatment selection characteristics in an effort to generate critical patient-centered information to aid in decision making in localized disease. The proposed study will generate the critical information that patients need to make decisions about PCa treatment that reflect their personal preferences and values. Using an existing population-based study of 3,691 men diagnosed with PCa in 2011, we will collect patient-reported outcomes three years after their diagnosis. The study participants underwent a variety of treatments, including open and robotic surgery, modern radiation techniques, and active surveillance. We have already collected patient-reported outcomes and medical record information at baseline, six, and 12 months after diagnosis. By collecting three-year outcomes, the study will determine which PCa treatments "work best; in which patients; and in whose hands." We will specifically compare the effectiveness of contemporary surgical and radiation techniques for localized PCa in terms of the six-, 12-, and 36-month patient-reported outcomes and quality of life, side effects, cancer control, and treatment complications. Prior studies have identified these outcomes as the ones patients consider when choosing therapy. We will also identify subgroups of patients who respond better to certain treatments than others, effectively tailoring the results of the study to the individual patient. Finally, we will explore how the effectiveness of therapy is influenced by the quality of care delivered, in hopes of aiding patients not only in choosing which treatment to receive, but which facility/provider they should use to deliver their care. More on this project:(1) O'Neil B, Koyama T, Alvarez J, Conwill RM, Albertsen PC, Cooperberg MR, Goodman M, Greenfield S, Hamilton AS, Hoffman KE, Hoffman RM, Kaplan SH, Stanford JL, Stroup AM, Paddock LE, Wu XC, Stephenson RA, Resnick MJ, Barocas DA, Penson DF. The Comparative Harms of Open and Robotic Prostatectomy in Population Based Samples. J Urol. 2016 Feb;195(2):321-9. doi: 10.1016/j.juro.2015.08.092. PubMed PMID: 26343985. (2) Prostate Cancer: Voices of Experience--A narrative on the difficult decisions newly diagnosed prostate cancer patients have to make and the men who join Vanderbilt University researchers to personalize information on treatment outcomes.
MeSH Terms:
  • Cohort Studies
  • Comparative Effectiveness Research
  • * Decision Making
  • * Decision Support Systems, Clinical
  • Humans
  • Male
  • Outcome Assessment, Health Care
  • Patient Preference
  • Patient-Centered Care
  • Prostatic Neoplasms /*radiotherapy
  • /*surgery
  • Quality of Life
  • United States
  • Watchful Waiting
Country: United States
State: Tennessee
Zip Code: 37232
UI: 20143300
CTgovId: NCT01326286
Project Status: Completed
Record History: ('2017: Project extended to 2017.',) ('2018: Project extended to 2018.',)