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Clinical Trials/NCT03387527
NCT03387527
Completed
Not Applicable

Using Decision Analysis to Enhance Decision-Making Regarding Prostate Cancer Screening

Case Comprehensive Cancer Center1 site in 1 country50 target enrollmentFebruary 1, 2018
ConditionsProstate Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
Case Comprehensive Cancer Center
Enrollment
50
Locations
1
Primary Endpoint
Number of initial interviews completed in 60 minutes
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2018
End Date
November 3, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Number of initial interviews completed in 60 minutes

Time Frame: 60 minutes from beginning of interview

To be considered feasible in a busy clinical setting, researchers anticipate 80% of the initial interviews to be completed within the allotted 60-minute interview time.

Secondary Outcomes

  • Health Literacy(1 month after clinical visit)
  • Decisional conflict Scale(1 month after clinical visit)
  • Decisional regret scale(1 month after clinical visit)
  • Multidimensional measure of informed choice(1 month after clinical visit)
  • Patient decisional control preferences(1 month after clinical visit)

Study Sites (1)

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