Clinical trial NCT00432601: Testing the Helpfulness of 2 Decision Aids for Prostate Cancer
Official title: Impact of a Plain Language Prostate Cancer Decision Aid on Decision Making
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: decision aid
prostate cancer
patient-physician communication
decision making
literacy
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2007-02-08
Enrollment: 1028
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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

Primary outcomes:
measure: Knowledge
timeFrame: Results visit (Time 2 - approximately 7-10 days after Time 1)
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: VA Medical Center, San Francisco
state: California
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System
state: Michigan
city: Durham
country: United States
facility: VA Medical Center
state: North Carolina
city: Pittsburgh
country: United States
facility: Center for Health Equity Research and Promotion
state: Pennsylvania
Study officials:
affiliation: VA Ann Arbor Healthcare System
name: Angela Fagerlin, PhD MA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Levy MH, Back A, Benedetti C, Billings JA, Block S, Boston B, Bruera E, Dy S, Eberle C, Foley KM, Karver SB, Knight SJ, Misra S, Ritchie CS, Spiegel D, Sutton L, Urba S, Von Roenn JH, Weinstein SM. NCCN clinical practice guidelines in oncology: palliative care. J Natl Compr Canc Netw. 2009 Apr;7(4):436-73. doi: 10.6004/jnccn.2009.0031. No abstract available.