Testing Decision Aids About Early Stage Prostate Cancer

Not Applicable

Completed

• Conditions: Prostatic Neoplasms
• Interventions: Behavioral: DVD Decision Aid; Behavioral: Written decision aid

• Registration Number: NCT02053389
• Lead Sponsor: University of Michigan

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2013-12-19
• Study First Submitted QC: 2014-01-30
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Study First Posted: 2014-02-03
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-28
• Last Update Posted: 2015-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 564

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

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Exclusion Criteria

• Previous diagnosis of prostate cancer

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DVD Decision Aid	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.
Written Decision Aid	Written decision aid	Eligible participants receive the written decision aid ("Making the Choice: Deciding What to Do About Early Stage Prostate Cancer") alone.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Michigan Health System; 🇺🇸 Ann Arbor, Michigan, United States