Testing the Helpfulness of 2 Decision Aids for Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test different methods for communicating information about prostate cancer treatment to men. The investigators are studying how best to present information so men can make informed decisions about what prostate cancer treatment to undergo.

Detailed Description
-----------------
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.

Official Title
-----------------
Impact of a Plain Language Prostate Cancer Decision Aid on Decision Making

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Behavioral: type of decision aid


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Patients will receive Michigan Cancer Consortium decision aid. | Behavioral: type of decision aid<br>* We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication.<br>|
| Active Comparator: Arm 2<br>Patients will receive National Comprehensive Cancer Network decision aid. | Behavioral: type of decision aid<br>* We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge | Questions addressed the survival benefit and side effects associated with treatment options for localized prostate cancer. | Results visit (Time 2 - approximately 7-10 days after Time 1) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
decision aid, prostate cancer, patient-physician communication, decision making, literacy