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Testing Decision Aids About Early Stage Prostate Cancer

Primary Purpose

Prostatic Neoplasms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DVD Decision Aid
Written decision aid
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Prostatic Neoplasms focused on measuring Patient-Physician communication, Decision Support Techniques, Health Communication, Physician-Patient Relationship, Decision Making

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DVD Decision Aid

Written Decision Aid

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Self-efficacy for discussing preferences (intention)
14 item survey instrument
Self-efficacy for discussing preferences (intention)
14 item survey instrument
Self-efficacy for discussing preferences (actual)
14 item survey instrument

Secondary Outcome Measures

Preference for shared decision making
1 item survey instrument
Preference for shared decision making
1 item survey instrument
Prostate cancer related knowledge
10 item survey instrument
Prostate cancer related knowledge
10 item survey instrument
Prostate cancer related knowledge
12 item survey instrument
Prostate cancer related anxiety
6 item survey instrument
Prostate cancer related anxiety
6 item survey instrument
Prostate cancer related anxiety
6 item survey instrument
Prostate cancer related anxiety
7 item survey instrument
Treatment preference
1 item survey instrument
Treatment decision
2 item survey instrument
Treatment decision
2 item survey instrument
Decisional regret
5 item survey instrument
Preference for shared decision making
1 item survey instrument
Preference for shared decision making
1 item survey instrument

Full Information

First Posted
December 19, 2013
Last Updated
May 28, 2015
Sponsor
University of Michigan
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02053389
Brief Title
Testing Decision Aids About Early Stage Prostate Cancer
Official Title
Promoting Shared Decision Making in Prostate Cancer Through Decision Aids
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms
Keywords
Patient-Physician communication, Decision Support Techniques, Health Communication, Physician-Patient Relationship, Decision Making

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
564 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DVD Decision Aid
Arm Type
Experimental
Arm Description
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.
Arm Title
Written Decision Aid
Arm Type
Active Comparator
Arm Description
Eligible participants receive the written decision aid ("Making the Choice: Deciding What to Do About Early Stage Prostate Cancer") alone.
Intervention Type
Behavioral
Intervention Name(s)
DVD Decision Aid
Intervention Description
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
Intervention Name(s)
Written decision aid
Intervention Description
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.
Primary Outcome Measure Information:
Title
Self-efficacy for discussing preferences (intention)
Description
14 item survey instrument
Time Frame
Time 1 (baseline)
Title
Self-efficacy for discussing preferences (intention)
Description
14 item survey instrument
Time Frame
Time 2 (post-intervention, an average of 3 days after Time 1 baseline)
Title
Self-efficacy for discussing preferences (actual)
Description
14 item survey instrument
Time Frame
Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline)
Secondary Outcome Measure Information:
Title
Preference for shared decision making
Description
1 item survey instrument
Time Frame
Time 1 (baseline)
Title
Preference for shared decision making
Description
1 item survey instrument
Time Frame
Time 2 (post-intervention, an average of 3 days after Time 1 baseline)
Title
Prostate cancer related knowledge
Description
10 item survey instrument
Time Frame
Time 1 (baseline)
Title
Prostate cancer related knowledge
Description
10 item survey instrument
Time Frame
Time 2 (post-intervention, an average of 3 days after Time 1 baseline)
Title
Prostate cancer related knowledge
Description
12 item survey instrument
Time Frame
Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline)
Title
Prostate cancer related anxiety
Description
6 item survey instrument
Time Frame
Time 1 (baseline)
Title
Prostate cancer related anxiety
Description
6 item survey instrument
Time Frame
Time 2 (post-intervention, an average of 3 days after Time 1 baseline)
Title
Prostate cancer related anxiety
Description
6 item survey instrument
Time Frame
Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline)
Title
Prostate cancer related anxiety
Description
7 item survey instrument
Time Frame
Time 4 (6 months post diagnosis)
Title
Treatment preference
Description
1 item survey instrument
Time Frame
Time 2 (post-intervention, an average of 3 days after Time 1 baseline)
Title
Treatment decision
Description
2 item survey instrument
Time Frame
Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline)
Title
Treatment decision
Description
2 item survey instrument
Time Frame
Time 4 (6 months post diagnosis)
Title
Decisional regret
Description
5 item survey instrument
Time Frame
Time 4 (6 months post diagnosis)
Title
Preference for shared decision making
Description
1 item survey instrument
Time Frame
Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline)
Title
Preference for shared decision making
Description
1 item survey instrument
Time Frame
Time 4 (6 months post diagnosis)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela T Fagerlin, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35727324
Citation
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.
Results Reference
derived

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Testing Decision Aids About Early Stage Prostate Cancer

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