Testing Decision Aids About Early Stage Prostate Cancer

NCT02053389 | Completed DMC

• 2 other identifiers: F021723 - 060077P50CA101451-10
• Study Type: interventional
• Target: 564
• Locations: 1 country
• Sites: 1

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

Conditions

Prostatic Neoplasms

Keywords

Patient-Physician communication; Decision Support Techniques; Health Communication; Physician-Patient Relationship; Decision Making

Outcome Measures

Primary Outcomes (3)

• Self-efficacy for discussing preferences (intention)

  14 item survey instrument

  Time 1 (baseline)

• Self-efficacy for discussing preferences (intention)

  14 item survey instrument

  Time 2 (post-intervention, an average of 3 days after Time 1 baseline)

• Self-efficacy for discussing preferences (actual)

  14 item survey instrument

  Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline)

Secondary Outcomes (15)

• Preference for shared decision making

  Time 1 (baseline)

• Preference for shared decision making

  Time 2 (post-intervention, an average of 3 days after Time 1 baseline)

• Prostate cancer related knowledge

  Time 1 (baseline)

• Prostate cancer related knowledge

  Time 2 (post-intervention, an average of 3 days after Time 1 baseline)

• Prostate cancer related knowledge

  Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline)

Study Arms (2)

DVD Decision Aid

EXPERIMENTAL

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

Written Decision Aid

ACTIVE COMPARATOR

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

Behavioral: Written decision aid

Interventions

DVD Decision Aid 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.

DVD Decision Aid

Written decision aid 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.

Written Decision Aid

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Previous diagnosis of prostate cancer

Sponsors & Collaborators

• University of Michigan: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• 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.

  PMID: 35727324 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Angela T Fagerlin, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 19, 2013
• First Posted: February 3, 2014
• Study Start: November 1, 2010
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: June 1, 2015

Record last verified: 2015-05

Locations

US (1)