Testing Decision Aids About Early Stage Prostate Cancer

NCT ID: NCT02053389

Last Updated: 2015-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

564 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2014-02-28

Brief Summary

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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

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Conditions

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Prostatic Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

DVD Decision Aid

Intervention Type BEHAVIORAL

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

Eligible participants receive the written decision aid ("Making the Choice: Deciding What to Do About Early Stage Prostate Cancer") alone.

Group Type ACTIVE_COMPARATOR

Written decision aid

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Angela Fagerlin

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Angela T Fagerlin, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan Health System

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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Fridman I, Ubel PA, Kahn VC, Fagerlin A. Association of quantitative information and patient knowledge about prostate cancer outcomes. Health Psychol. 2022 Jul;41(7):484-491. doi: 10.1037/hea0001196.

Reference Type DERIVED
PMID: 35727324 (View on PubMed)

Other Identifiers

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P50CA101451-10

Identifier Type: NIH

Identifier Source: secondary_id

View Link

F021723 - 060077

Identifier Type: -

Identifier Source: org_study_id

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