• knowledge, risk perception, decision making, patient-physician communication [ Time Frame: Prebiopsy appointment (Time 1); Diagnosis visit (Time 2); 7-10 Days After Diagnosis visit (Time 3) ] [ Designated as safety issue: No ]
  

• satisfaction with decision aid, anxiety [ Time Frame: Anxiety:Prebiopsy appointment (Time 1); Diagnosis visit (Time 2); 7-10 Days After Diagnosis visit (Time 3). Satisfaction: 7-10 Days After Diagnosis visit (Time 3) ] [ Designated as safety issue: No ]
  

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 trails 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 to 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 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.