Testing the Helpfulness of 2 Decision Aids for Prostate Cancer

Background/Rationale: Prostate cancer is the second leading cause of cancer related death
among men in the United States, and accounts for 29% of all cancers diagnosed in men.
Furthermore, approximately one in six men will be diagnosed with prostate cancer in their
lifetime. Thus, 17% of male Veterans will be asked to make a decision about the treatment of
their prostate cancer. The burden of this disease is further magnified when one considers
that most patients will live for years following their diagnosis and with any adverse
effects of therapy. Given that there have been no clinical trials showing that any prostate
cancer treatment produces an increased likelihood of survival; men are asked to actively
participate in treatment decisions. Previous research has revealed that men are often
uninformed about their prostate cancer, particularly African American men and men with lower
educational attainment. Thus, it is critical to develop and test decision aids that can help
all men (especially men with low literacy skills) make an informed decision.

Objective(s): The goal of the study is to compare the impact of a plain language decision
aid (DA) to a conventional DA on prostate cancer patients' decision making experience and
communication with their physician.

Methods: This study is a randomized controlled trial. Men undergoing a prostate biopsy will
be recruited at the time of biopsy and complete a baseline interview (at pre-biopsy or
biopsy appointment). Those patients diagnosed with localized prostate cancer will complete
two additional interviews: at physician visit (diagnosis), and 7-10 days following physician
visit (phone survey). The treatment discussion between patients and their physician will be
audio recorded.

Major characteristics: All men, without a prior history of prostate cancer, undergoing a
prostate biopsy will be screened for eligibility and enrolled by the study coordinator.
Additional inclusion criteria include ability to speak English, provide informed consent,
and have a PSA < 20. Physicians can refuse to allow a patient participate in the study at
the time of biopsy. Men will be recruited from 4 VA hospitals (Ann Arbor, Durham,
Pittsburgh, and San Francisco) and randomized to receive one of two decision aid booklets
(plain language vs. conventional).

Major variables and source(s) of data: All survey data will be collected from either
face-to-face or phone interviews. The surveys include measures of literacy, numeracy,
anxiety, preference for shared decision making, knowledge, treatment preferences, risk
perceptions, perception of patient-physician communication, and confidence and satisfaction
with the decision making process. All survey questions were read aloud and responses
recorded.

Status: Recruitment began in September 2008 and concluded in May of 2012.

1552 men were approached to participate in the study with 1028 agreeing. 1023 completed the
Time 1 interview. Of the 334 subjects eligible to continue with study activities, 285
subjects completed the Time 2 interview (biopsy results visit), and 244 completed the Time 3
phone interview.

Inclusion Criteria:

Men undergoing a prostate cancer biopsy at Ann Arbor, Durham, San Francisco, or Pittsburgh
VAs. Additional inclusion criteria includes ability to speak English, provide informed
consent, and have a PSA < 20.

Exclusion Criteria:

Prior history of prostate cancer