Testing Decision Aids About Early Stage Prostate Cancer

May 28, 2015 updated by: Angela Fagerlin, University of Michigan

Promoting Shared Decision Making in Prostate Cancer Through Decision Aids

This is an educational intervention study testing the effects of decision aids in promoting patient participation in early stage prostate cancer treatment decision making. The purpose of this study is to compare patient-physician communication between patients who receive a DVD that models patient communication strategies vs. those who do not receive a DVD. All patients will also receive a written decision aid that describes treatment options for early stage prostate cancer. The Investigators hypothesize that the DVD will:

  • increase patients' perceptions of the importance of their preferences to their decision making
  • increase patients' perceptions of their intention to discuss their values and preferences with their urologists and radiation oncologists
  • increase patients' actual engagement with their physician during the clinical encounter
  • increase the concordance between patient decision making preferences and actual decision making outcomes
  • increase long term satisfaction with decision on type of treatment selected
  • increase patient satisfaction with their decision and the decision making process
  • influence patient perception of his physician (e.g., trust) and of the diagnosis visit

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

564

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Men aged 18 years and older
  • Scheduled for a prostate biopsy to test for prostate cancer
  • Ability to read and answer survey questions in English

Exclusion Criteria:

  • Previous diagnosis of prostate cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DVD Decision Aid
Eligible participants receive the written decision aid ("Making the Choice: Deciding What to Do About Early Stage Prostate Cancer") AND the DVD decision aid ("Discussing the Choice: Talking with your Doctor about Early Stage Prostate Cancer"), which provides instruction and recommendations on how to participate in shared decision making with one's physician.
Behavioral: DVD Decision Aid
The decision aid, "Discussing the Choice: Talking with your Doctor about Early Stage Prostate Cancer" is a DVD modeling patient communication strategies. The DVD includes vignettes with actors depicting patient-physician discussions of prostate cancer treatments. In these vignettes, the patient models communication strategies designed to facilitate patient activation.
Active Comparator: Written Decision Aid
Eligible participants receive the written decision aid ("Making the Choice: Deciding What to Do About Early Stage Prostate Cancer") alone.
Behavioral: Written decision aid
A written decision aid entitled "Making the Choice: Deciding What to Do About Early Stage Prostate Cancer" that describes treatment options for early stage prostate cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-efficacy for discussing preferences (intention)
Time Frame: Time 1 (baseline)
14 item survey instrument
Time 1 (baseline)
Self-efficacy for discussing preferences (intention)
Time Frame: Time 2 (post-intervention, an average of 3 days after Time 1 baseline)
14 item survey instrument
Time 2 (post-intervention, an average of 3 days after Time 1 baseline)
Self-efficacy for discussing preferences (actual)
Time Frame: Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline)
14 item survey instrument
Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preference for shared decision making
Time Frame: Time 1 (baseline)
1 item survey instrument
Time 1 (baseline)
Preference for shared decision making
Time Frame: Time 2 (post-intervention, an average of 3 days after Time 1 baseline)
1 item survey instrument
Time 2 (post-intervention, an average of 3 days after Time 1 baseline)
Prostate cancer related knowledge
Time Frame: Time 1 (baseline)
10 item survey instrument
Time 1 (baseline)
Prostate cancer related knowledge
Time Frame: Time 2 (post-intervention, an average of 3 days after Time 1 baseline)
10 item survey instrument
Time 2 (post-intervention, an average of 3 days after Time 1 baseline)
Prostate cancer related knowledge
Time Frame: Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline)
12 item survey instrument
Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline)
Prostate cancer related anxiety
Time Frame: Time 1 (baseline)
6 item survey instrument
Time 1 (baseline)
Prostate cancer related anxiety
Time Frame: Time 2 (post-intervention, an average of 3 days after Time 1 baseline)
6 item survey instrument
Time 2 (post-intervention, an average of 3 days after Time 1 baseline)
Prostate cancer related anxiety
Time Frame: Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline)
6 item survey instrument
Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline)
Prostate cancer related anxiety
Time Frame: Time 4 (6 months post diagnosis)
7 item survey instrument
Time 4 (6 months post diagnosis)
Treatment preference
Time Frame: Time 2 (post-intervention, an average of 3 days after Time 1 baseline)
1 item survey instrument
Time 2 (post-intervention, an average of 3 days after Time 1 baseline)
Treatment decision
Time Frame: Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline)
2 item survey instrument
Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline)
Treatment decision
Time Frame: Time 4 (6 months post diagnosis)
2 item survey instrument
Time 4 (6 months post diagnosis)
Decisional regret
Time Frame: Time 4 (6 months post diagnosis)
5 item survey instrument
Time 4 (6 months post diagnosis)
Preference for shared decision making
Time Frame: Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline)
1 item survey instrument
Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline)
Preference for shared decision making
Time Frame: Time 4 (6 months post diagnosis)
1 item survey instrument
Time 4 (6 months post diagnosis)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Angela T Fagerlin, PhD, University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

December 19, 2013

First Submitted That Met QC Criteria

January 30, 2014

First Posted (Estimate)

February 3, 2014

Study Record Updates

Last Update Posted (Estimate)

June 1, 2015

Last Update Submitted That Met QC Criteria

May 28, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F021723 - 060077
  • P50CA101451-10 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostatic Neoplasms

Clinical Trials on DVD Decision Aid

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe