Clinical trial NCT03387527: Using Decision Analysis to Enhance Decision-Making Regarding Prostate Cancer Screening
Official title: Using Decision Analysis to Enhance Decision-Making Regarding Prostate Cancer Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Decision Aid
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2018-01-02
Enrollment: 50
Sex: MALE
Minimum age (years): 55
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate a new counseling tool for patients deciding whether or not to undergo prostate cancer screening. This screening decision aid is a computer program that provides individual patients estimates of their risks of prostate cancer diagnosis, prostate cancer related death, or death from any cause. The researchers are evaluating whether or not patients find this screening decision aid helpful. As part of this study, participants will be asked for their response on questionnaires.

If patients find the screening decision aid helpful, the researchers will make it available at other clinic locations.

Detailed description: To conduct a feasibility study on implementing the computer-based screening decision aid for prostate cancer screening in a primary care setting during a 60-minute interview. To aid in informed decision making, the screening decision aid will include a graphical representation of predicted probabilities of prostate cancer diagnosis, prostate cancer-specific mortality, death from competing causes based on a man's unique demographic information. The study team will provide standardized counseling followed by individualized counseling with the screening decision aid. It will assess the quality of the decision making process (patient feels knowledgeable, informed of the risks/benefits, feels clear about their values, is involved in the decision), and quality of the decision.

Eligibility criteria: Inclusion Criteria:

* Life expectancy \> 10 years
* Ability to read English

Exclusion Criteria:

* Personal history of prostate cancer
* Personal history of prostate biopsy or prostate surgery
* Prior prostate specific antigen screening in the past year leading up to their scheduled clinic visit
* Cognitive impairment

Primary outcomes:
measure: Number of initial interviews completed in 60 minutes
timeFrame: 60 minutes from beginning of interview
Secondary outcomes:
measure: Health Literacy
timeFrame: 1 month after clinical visit
measure: Patient decisional control preferences
timeFrame: 1 month after clinical visit
measure: Decisional conflict Scale
timeFrame: 1 month after clinical visit
measure: Multidimensional measure of informed choice
timeFrame: 1 month after clinical visit
measure: Decisional regret scale
timeFrame: 1 month after clinical visit
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
name: Michael A Brooks, MD
role: PRINCIPAL_INVESTIGATOR
References: