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Testing Decision Aids About Early Stage Prostate Cancer

Promoting Shared Decision Making in Prostate Cancer Through Decision Aids

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02053389
Enrollment
564
Registered
2014-02-03
Start date
2010-11-30
Completion date
2014-02-28
Last updated
2015-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatic Neoplasms

Keywords

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

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

Interventions

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.

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.

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
University of Michigan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Self-efficacy for discussing preferences (intention)Time 1 (baseline)14 item survey instrument
Self-efficacy for discussing preferences (actual)Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline)14 item survey instrument

Secondary

MeasureTime frameDescription
Prostate cancer related anxietyTime 1 (baseline)6 item survey instrument
Treatment preferenceTime 2 (post-intervention, an average of 3 days after Time 1 baseline)1 item survey instrument
Prostate cancer related knowledgeTime 1 (baseline)10 item survey instrument
Decisional regretTime 4 (6 months post diagnosis)5 item survey instrument
Treatment decisionTime 3 (post-diagnosis, an average of 1 month after Time 1 baseline)2 item survey instrument
Preference for shared decision makingTime 1 (baseline)1 item survey instrument

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026