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Facilitating Shared Decisionmaking About Prostate Cancer Screening

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00013247
First Posted: March 16, 2001
Last Update Posted: April 7, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
  Purpose
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.

Condition Intervention
Prostate Cancer Behavioral: Prostate Cancer Screening Education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Facilitating Shared Decisionmaking About Prostate Cancer Screening

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Estimated Enrollment: 1152
Study Completion Date: December 2002
Arms Assigned Interventions
Arm 1 Behavioral: Prostate Cancer Screening Education

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00013247


Locations
United States, Minnesota
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States, 55417
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Melissa R. Partin, PhD Minneapolis VA Health Care System, Minneapolis, MN
  More Information

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00013247     History of Changes
Other Study ID Numbers: IIR 99-277
First Submitted: March 14, 2001
First Posted: March 16, 2001
Last Update Posted: April 7, 2015
Last Verified: February 2007

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases