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
  Purpose

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.


Condition Intervention
Prostate Cancer
Behavioral: type of decision aid

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Impact of a Plain Language Prostate Cancer Decision Aid on Decision Making

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 500
Study Start Date: August 2008
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Patients will receive Michigan Cancer Consortium decision aid.
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.
Active Comparator: Arm 2
Patients will receive National Comprehensive Cancer Network decision aid.
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.

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00432601

Locations
United States, California
VA Medical Center, San Francisco
San Francisco, California, United States, 94121
United States, Michigan
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States, 48113
United States, North Carolina
VA Medical Center
Durham, North Carolina, United States, 27705
United States, Pennsylvania
Center for Health Equity Research and Promotion
Pittsburgh, Pennsylvania, United States, 15206
Sponsors and Collaborators
Investigators
Principal Investigator: Angela Fagerlin, PhD MA VA Ann Arbor Healthcare System
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00432601     History of Changes
Other Study ID Numbers: IIR 05-283
Study First Received: February 6, 2007
Last Updated: February 6, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
decision aid
prostate cancer
patient-physician communication
decision making
literacy

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

ClinicalTrials.gov processed this record on July 20, 2014