and Quality, Knowing Your Options, will be tested
during the trial (see Figure 2, this page).
The A191402 study will oversample African-American,
Native American, and Alaska-Native men with half of
the enrollment slots reserved for this population. We
have identified strategic partner sites to help us achieve
these demographic recruitment targets. The aim of the
study is to test the impact of the two different decision
aids, alone and in combination, on patient knowledge and
one-year quality of life in comparison with usual care.
We will use a “cluster-randomized” design,
which assigns institutions to different intervention
arms. As a result, all patients and physicians at a
given site will get the same interventions. We will
use statistical methods to ensure that site-to-site
differences are accounted for, while making certain that
“contamination” across study arms is minimized.
Planning for this trial began in 2012. Since then,
we have been privileged to establish collaborations
with national leaders in prostate cancer survivorship as
well as with many colleagues in the urologic oncology
community through the National Cancer Institute’s
Community Oncology Research Program. The trial
opens this month. For more information, contact
Simon P. Kim, MD, MPH at email@example.com, or Jon
C. Tilburt, MD, MPH, at firstname.lastname@example.org. ♦
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April 3, 2017.
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5. Kim SP, Boorjian SA, Shah ND, et al. Disparities
in access to hospitals with robotic surgery for
patients with prostate cancer undergoing radical
prostatectomy. J Urol. 2013;189( 2):514-520.
6. Taksler GB, Keating NL, Cutler DM. Explaining
racial differences in prostate cancer mortality.
Cancer. 2012;118( 17):4280-4289.
7. Hayn MH, Orom H, Shavers VL, et al. Racial/
ethnic differences in receipt of pelvic lymph node
dissection among men with localized/regional
prostate cancer. Cancer. 2011;117( 20):4651-4658.
8. Underwood W III, Jackson J, Wei JT, et al. Racial
treatment trends in localized/regional prostate
carcinoma: 1992–999. Cancer. 2005;103( 3):538-545.
Pre- and during-
consult decision aids ( 1, 2)
decision aid only ( 1)
decision aid only ( 2)
1. Knowing Your Options
2. Prostate Cancer Choice
MAY 2017 BULLETIN American College of Surgeons