Facilitating Shared Decisionmaking About Prostate Cancer Screening
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prostate Cancer Screening Education
Sponsored by

About this trial
This is an interventional treatment trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria: Patients must be male veterans, age 50 and older, with a scheduled primary care appointment at one of 5 VISN 13 medical facilities. Patients diagnosed with prostate cancer will be excluded. Exclusion Criteria:
Sites / Locations
- Minneapolis VA Health Care System, Minneapolis, MN
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Arm 1
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00013247
First Posted
March 14, 2001
Last Updated
April 6, 2015
Sponsor
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00013247
Brief Title
Facilitating Shared Decisionmaking About Prostate Cancer Screening
Official Title
Facilitating Shared Decisionmaking About Prostate Cancer Screening
Study Type
Interventional
2. Study Status
Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2002 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Due to the disputed efficacy of prostate cancer (CaP) screening and treatment, most authorities recommend that providers inform and involve patients in CaP screening decisions.
Detailed Description
Background:
Due to the disputed efficacy of prostate cancer (CaP) screening and treatment, most authorities recommend that providers inform and involve patients in CaP screening decisions.
Objectives:
This study evaluated two interventions designed to facilitate this process.
Methods:
1152 male veterans age 50+ with no CaP and primary care appointments at four VA medical facilities in VISN 23 were randomly assigned to one of three groups: mailed pamphlet intervention, mailed video intervention, or usual care (control). Intervention materials were mailed two weeks prior to a target primary care appointment and patient telephone surveys were conducted one week (T1) and one year (T2) after the target appointment. Outcomes included: a 10- item validated knowledge index; responses to questions on CaP natural history, treatment efficacy, PSA accuracy, and expert disagreement about the PSA; whether screening was discussed with provider; scores on decision information seeking, participation and satisfaction scales; screening and treatment preferences; and PSA testing rates.
Status:
Complete
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
Enrollment
1152 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Prostate Cancer Screening Education
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must be male veterans, age 50 and older, with a scheduled primary care appointment at one of 5 VISN 13 medical facilities. Patients diagnosed with prostate cancer will be excluded.
Exclusion Criteria:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa R. Partin, PhD
Organizational Affiliation
Minneapolis VA Health Care System, Minneapolis, MN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Minneapolis VA Health Care System, Minneapolis, MN
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16911143
Citation
Partin MR, Nelson D, Flood AB, Friedemann-Sanchez G, Wilt TJ. Who uses decision aids? Subgroup analyses from a randomized controlled effectiveness trial of two prostate cancer screening decision support interventions. Health Expect. 2006 Sep;9(3):285-95. doi: 10.1111/j.1369-7625.2006.00400.x.
Results Reference
result
PubMed Identifier
15288907
Citation
Radosevich DM, Partin MR, Nugent S, Nelson D, Flood AB, Holtzman J, Dillon N, Haas M, Wilt TJ. Measuring patient knowledge of the risks and benefits of prostate cancer screening. Patient Educ Couns. 2004 Aug;54(2):143-52. doi: 10.1016/S0738-3991(03)00207-6.
Results Reference
result
PubMed Identifier
15541329
Citation
Wilt TJ, Partin MR. Reducing PSAnxiety: The importance of noninvasive chronic disease management in prostate cancer detection and treatment. Am J Med. 2004 Nov 15;117(10):796-8. doi: 10.1016/j.amjmed.2004.10.002. No abstract available.
Results Reference
result
PubMed Identifier
14587206
Citation
Wilt TJ, Partin MR. Prostate cancer intervention. Involving the patient in early detection and treatment. Postgrad Med. 2003 Oct;114(4):43-9; quiz 50. doi: 10.3810/pgm.2003.10.1506. Erratum In: Postgrad Med. 2004 Feb;115(2):7.
Results Reference
result
PubMed Identifier
15242468
Citation
Partin MR, Nelson D, Radosevich D, Nugent S, Flood AB, Dillon N, Holtzman J, Haas M, Wilt TJ. Randomized trial examining the effect of two prostate cancer screening educational interventions on patient knowledge, preferences, and behaviors. J Gen Intern Med. 2004 Aug;19(8):835-42. doi: 10.1111/j.1525-1497.2004.30047.x.
Results Reference
result
Citation
Taylor BC, Wilt TJ, Clothier B, Grill JP, Partin MR. Assessing health status in older men with lower urinary tract symptoms. Federal practitioner : for the health care professionals of the VA, DoD, and PHS. 2006 Jul 1; 23(7):29-40.
Results Reference
result
Learn more about this trial
Facilitating Shared Decisionmaking About Prostate Cancer Screening
We'll reach out to this number within 24 hrs