Trial Information

Impact of a Plain Language Prostate Cancer Decision Aid on Decision Making

Background:

Background/Rationale: Prostate cancer is the second leading cause of related death among men
in the United States, and accounts for 33% 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, once diagnosed, will live for years following their diagnosis and with any adverse
effects of therapy. Given that there have been no clinical trials which have proven that any
prostate cancer treatment produces an increased likelihood of survival; men are asked to
actively participate in decisions about what treatment to undergo. 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. However, this study will go beyond most decision aid research which has
focused primarily on knowledge, treatment choice, and decisional conflict and will examine
the impact of a decision aid on patient-physician interactions. Furthermore, invirtually no
research has tested the use of decision aids with low literacy patients, as this study will.

Objectives:

Objective(s): To test the impact of a plain language decision aid (i.e., a low reading
level) on prostate cancer patient's decision making experience and in their interactions
with their physician and the VA health system. This study will also test if there are
differences in receipt of active treatment between men with low vs. high literacy skills.

Methods:

Methods: The proposed study will be a randomized controlled trial. Men who are undergoing a
prostate biopsy will be recruited at the time of biopsy and those patients with a positive
biopsy result will be interviewed at 3 time points: Baseline (at pre-biopsy or biopsy
appointment), at physician visit (diagnosis), and 10 days following physician visit (phone
survey). Also, the treatment discussion between patients and their physician will be taped
and coded.

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
before they undergo a prostate biopsy. Additional inclusion criteria include ability to
speak English, provide informed consent, and having a 5 year or greater expected survival as
determined by their physician. Physicians can refuse to allow a patient participate in the
study at the time of biopsy. 500 men will be recruited at 4 VAs: Ann Arbor, Pittsburgh, San
Francisco and Durham. Men will be randomized to either receive one of two types of decision
aids.

Major variables and source(s) of data: All survey data will come from either face-to-face or
phone interviews. Survey variables testing the impact of the decision aid will include: 1)
treatment decision, 2) involvement in the decision making process, 3) knowledge of risks and
benefits, 4) self-efficacy for decision making, and 5) satisfaction with decision aid.

Status:

Recruitment began 9/2/08 and is now closed.

The investigators recruited 1028 subjects and 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.