Testing the Helpfulness of 2 Decision Aids for Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00432601
First received: February 6, 2007
Last updated: February 6, 2014
Last verified: October 2012

February 6, 2007
February 6, 2014
August 2008
September 2012   (final data collection date for primary outcome measure)
knowledge, risk perception, decision making, patient-physician communication [ Time Frame: Prebiopsy or biopsy appointment (Time 1); Results visit (Time 2); 7-10 Days After Results visit (Time 3) ] [ Designated as safety issue: No ]
knowledge, risk perception, decision making, patient-physician communication
Complete list of historical versions of study NCT00432601 on ClinicalTrials.gov Archive Site
satisfaction with decision aid, anxiety [ Time Frame: Anxiety: Prebiopsy appointment (Time 1); Results visit (Time 2); 7-10 Days After Diagnosis visit (Time 3). Satisfaction: 7-10 Days After Results visit (Time 3) ] [ Designated as safety issue: No ]
satisfaction with decision aid, anxiety
Not Provided
Not Provided
 
Testing the Helpfulness of 2 Decision Aids for Prostate Cancer
Impact of a Plain Language Prostate Cancer Decision Aid on Decision Making

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 good decisions about what prostate cancer treatment to undergo.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Prostate Cancer
Behavioral: type of decision aid
We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication.
  • Experimental: Arm 1
    Patients will receive Michigan Cancer Consortium decision aid.
    Intervention: Behavioral: type of decision aid
  • Active Comparator: Arm 2
    Patients will receive National Comprehensive Cancer Network decision aid.
    Intervention: Behavioral: type of decision aid
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. No abstract available.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
500
September 2012
September 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

Must be undergoing a prostate cancer biopsy at Ann Arbor, Durham, San Francisco, or Pittsburgh VAs

Exclusion Criteria:

Prior history of prostate cancer

Male
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00432601
IIR 05-283
Yes
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Angela Fagerlin, PhD MA VA Ann Arbor Healthcare System
Department of Veterans Affairs
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP