Clinical trial NCT02053389: Testing Decision Aids About Early Stage Prostate Cancer
Official title: Promoting Shared Decision Making in Prostate Cancer Through Decision Aids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Neoplasms
Keywords: Patient-Physician communication
Decision Support Techniques
Health Communication
Physician-Patient Relationship
Decision Making
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-02-03
Enrollment: 564
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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


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

Primary outcomes:
measure: Self-efficacy for discussing preferences (intention)
timeFrame: Time 1 (baseline)
measure: Self-efficacy for discussing preferences (intention)
timeFrame: Time 2 (post-intervention, an average of 3 days after Time 1 baseline)
measure: Self-efficacy for discussing preferences (actual)
timeFrame: Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline)
Secondary outcomes:
measure: Preference for shared decision making
timeFrame: Time 1 (baseline)
measure: Preference for shared decision making
timeFrame: Time 2 (post-intervention, an average of 3 days after Time 1 baseline)
measure: Prostate cancer related knowledge
timeFrame: Time 1 (baseline)
measure: Prostate cancer related knowledge
timeFrame: Time 2 (post-intervention, an average of 3 days after Time 1 baseline)
measure: Prostate cancer related knowledge
timeFrame: Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline)
measure: Prostate cancer related anxiety
timeFrame: Time 1 (baseline)
measure: Prostate cancer related anxiety
timeFrame: Time 2 (post-intervention, an average of 3 days after Time 1 baseline)
measure: Prostate cancer related anxiety
timeFrame: Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline)
measure: Prostate cancer related anxiety
timeFrame: Time 4 (6 months post diagnosis)
measure: Treatment preference
timeFrame: Time 2 (post-intervention, an average of 3 days after Time 1 baseline)
measure: Treatment decision
timeFrame: Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline)
measure: Treatment decision
timeFrame: Time 4 (6 months post diagnosis)
measure: Decisional regret
timeFrame: Time 4 (6 months post diagnosis)
measure: Preference for shared decision making
timeFrame: Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline)
measure: Preference for shared decision making
timeFrame: Time 4 (6 months post diagnosis)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
Study officials:
affiliation: University of Michigan
name: Angela T Fagerlin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.