Testing Decision Aids About Early Stage Prostate Cancer

Prostatic Neoplasms Clinical Trial

Official title:

Promoting Shared Decision Making in Prostate Cancer Through Decision Aids

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02053389
• Other study ID #: F021723 - 060077
• Secondary ID: P50CA101451-10
• Status: Completed
• Phase: N/A
• First received: December 19, 2013
• Last updated: May 28, 2015
• Start date: November 2010
• Est. completion date: February 2014

Study information

• Verified date: May 2015
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Data and Safety Monitoring Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 564
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Michigan Health System	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-efficacy for discussing preferences (intention)	14 item survey instrument	Time 1 (baseline)	No
Primary	Self-efficacy for discussing preferences (intention)	14 item survey instrument	Time 2 (post-intervention, an average of 3 days after Time 1 baseline)	No
Primary	Self-efficacy for discussing preferences (actual)	14 item survey instrument	Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline)	No
Secondary	Preference for shared decision making	1 item survey instrument	Time 1 (baseline)	No
Secondary	Preference for shared decision making	1 item survey instrument	Time 2 (post-intervention, an average of 3 days after Time 1 baseline)	No
Secondary	Prostate cancer related knowledge	10 item survey instrument	Time 1 (baseline)	No
Secondary	Prostate cancer related knowledge	10 item survey instrument	Time 2 (post-intervention, an average of 3 days after Time 1 baseline)	No
Secondary	Prostate cancer related knowledge	12 item survey instrument	Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline)	No
Secondary	Prostate cancer related anxiety	6 item survey instrument	Time 1 (baseline)	No
Secondary	Prostate cancer related anxiety	6 item survey instrument	Time 2 (post-intervention, an average of 3 days after Time 1 baseline)	No
Secondary	Prostate cancer related anxiety	6 item survey instrument	Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline)	No
Secondary	Prostate cancer related anxiety	7 item survey instrument	Time 4 (6 months post diagnosis)	No
Secondary	Treatment preference	1 item survey instrument	Time 2 (post-intervention, an average of 3 days after Time 1 baseline)	No
Secondary	Treatment decision	2 item survey instrument	Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline)	No
Secondary	Treatment decision	2 item survey instrument	Time 4 (6 months post diagnosis)	No
Secondary	Decisional regret	5 item survey instrument	Time 4 (6 months post diagnosis)	No
Secondary	Preference for shared decision making	1 item survey instrument	Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline)	No
Secondary	Preference for shared decision making	1 item survey instrument	Time 4 (6 months post diagnosis)	No