Trial Information

Treatment Decision Making in Early-Stage Prostate Cancer: Evaluation of Computer Based Patient Education and an Interactive Decision Aid

Background: There is a controversy in the medical community surrounding the utility of
treatment options for clinically localized prostate cancer. Although several options are
available for management of localized prostate cancer, no option is clearly superior to
others. The main therapeutic options for localized prostate cancer include radical
prostatectomy (RP), radiation therapy (RT; external beam radiation or brachytherapy), and
expectant management (EM) or "watchful waiting." The American Urological Association, after
a structured review of the available literature, concluded that there is insufficient
evidence to clearly recommend RP, RT, or EM. They recommended that factors such as life
expectancy, current health, and patient preference for therapeutic options be considered in
the treatment decision. Since the survival benefits of the different management strategies
are as of yet uncertain, and men's preferences for outcomes of therapy may influence the
decision regarding management choice, men should be informed of potential outcomes and
should be encouraged to examine their own values in deciding upon a management strategy for
their prostate cancer.

Objective: The primary goal is to evaluate a method of patient education that is designed
to provide treatment-related information and to help men clarify their preferences and
values via a recently developed computer-based decision aid. We expect that men randomized
to the decision aid condition will be more active in their treatment decision and will have
improved patient outcomes relative to men assigned to the Information only condition.

Specific Aims. The specific aims are: 1) To evaluate the relative impact of providing newly
diagnosed patients with computer-based prostate cancer treatment information vs. providing
patients with the information plus an interactive decision-aid on a) shared decision-making
practices and b) patient outcomes (decisional satisfaction, quality of life, knowledge), 2)
To explore the mechanisms by which the decision aid impacts on SDM and patient outcomes,
and 3) To identify men who are most and least likely to benefit from the education plus
decision-aid intervention.

Study Design: Men will be accrued at the time of their biopsy and those with a positive
biopsy result will receive the intervention following notification of the diagnosis but
prior to their initial meeting with the urologist in which treatment options are discussed.
Participants will be followed at one, six and twelve months post-intervention. The primary
outcomes include patient outcomes (knowledge, quality of life, and decisional satisfaction)
and shared decision making (SDM) practices.

Relevance In many areas of medicine, including treatment of localized prostate cancer, there
has been a rapid expansion of research that has resulted in a growing number of diagnostic
and treatment options that are available to physicians and patients. In many cases, there
are several effective and viable treatment options, but randomized clinical trials assessing
treatment effectiveness have not yet been completed. Although the availability of different
options will undoubtedly be beneficial in the long run, at present it creates a difficult
decision for individuals and physicians who are faced with the choices for which no best
answer is known. The proposed study is designed to assist patient through this decision, by
providing information and helping them to consider their values.