Facilitating Shared Decisionmaking About Prostate Cancer Screening

NCT ID: NCT00013247

Last Updated: 2015-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1152 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2002-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prostate Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm 1

Group Type OTHER

Prostate Cancer Screening Education

Intervention Type BEHAVIORAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Prostate Cancer Screening Education

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

US Department of Veterans Affairs

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Melissa R. Partin, PhD

Role: PRINCIPAL_INVESTIGATOR

Minneapolis VA Health Care System, Minneapolis, MN

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 16911143 (View on PubMed)

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.

Reference Type RESULT
PMID: 15288907 (View on PubMed)

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.

Reference Type RESULT
PMID: 15541329 (View on PubMed)

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.

Reference Type RESULT
PMID: 14587206 (View on PubMed)

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.

Reference Type RESULT
PMID: 15242468 (View on PubMed)

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.

Reference Type RESULT

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IIR 99-277

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Erectile Dysfunction Study
NCT00873665 COMPLETED NA
Effects of TNF Blockade on Human BPH/LUTS
NCT06062875 RECRUITING PHASE2