Treatment Decision Making in Early-Stage Prostate Cancer

NCT00196781 | Completed Phase 3 DMC

• 1 other identifier: DAMD17-02-1-0062
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

We plan to test the effectiveness of a recently developed computer-based program that is designed to improve patient knowledge about prostate cancer treatments. It is also designed to help men clarify their values using a computer-based 'decision aid.' A decision aid gives patients tools to help them understand their own values and how these values may be related to their choice of different forms of therapy for prostate cancer. In order to test the effectiveness of the decision aid, men will be assigned on a chance basis to receive either 1) the computer program that includes the information about prostate cancer treatments alone, or 2) the computer program that contains both the information and the decision aid. We expect that men in decision aid group will be more active in their treatment decision and will have improved knowledge, quality of life, and satisfaction with the treatment decision relative to men who only receive the information.

Conditions

Localized Prostate Cancer

Keywords

prostate cancer treatment; medical decision making; informed decision making; shared decision making; decision aid; patient education

Outcome Measures

Primary Outcomes (1)

• treatment satisfaction, quality of life, prostate cancer knowledge at 1, 6, and 12 months post random assignment

  one, six, and one year follow-up assesments

Secondary Outcomes (1)

• shared decision making at 1, 6, and 12 months post random assignment.

  one, six and one year follow-up assesments

Study Arms (2)

the Information + Decision Aid group

EXPERIMENTAL

Behavioral: CD-ROM-based prostate ca treatment education+decision tools

Information Only group

ACTIVE COMPARATOR

Behavioral: CD-ROM-based prostate cancer treatment education

Interventions

CD-ROM-based prostate cancer treatment education BEHAVIORAL

The goal was to explore men's use of a CD-ROM-based decision aid for early-stage PCa treatment decisions.

Also known as: Prostate Cancer Treatment Education

Information Only group

CD-ROM-based prostate ca treatment education+decision tools BEHAVIORAL

The goal of the present study was to explore men's use of a CD-ROM-based decision aid for early-stage PCa treatment decisions.

Also known as: Prostate Cancer treatment education, Decision Tools

the Information + Decision Aid group

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligibility criteria include: 1) ability to speak English, 2) absence of cognitive impairment that would limit participation in the study. 3) Diagnosis of localized prostate cancer. Participants will not be limited by age.

You may not qualify if:

• Men who have already made a treatment decision.

Sponsors & Collaborators

• Georgetown University: lead
• U.S. Army Medical Research and Development Command: collaborator

Study Sites (1)

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Study Officials

• Kathryn L. Taylor, Ph.D.

  Georgetown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: September 1, 2002
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2005
• Last Updated: January 13, 2010

Record last verified: 2010-01

Locations

US (1)