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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 3, 2018

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.

Interventions

  • Behavioral: Prostate cancer decision aid
    • Patients will undergo standardized counseling and individualized counseling with the screening decision aid. The 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

Arms, Groups and Cohorts

  • Experimental: Prostate Cancer Decision Aid
    • The research intervention will be exposure to the screening decision aid. Patients will receive standardized counseling including population based risks and benefits of prostate cancer screening. Then, patients will be given opportunity to review the screening decision aid prior to offering a decision on whether or not to undergo prostate cancer screening. The patient decision aid will be a computer application that generates predicted risks associated with prostate cancer.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Health Literacy
    • Time Frame: 1 month after clinical visit
    • Five item scale measuring attitudes towards screening
  • Patient decisional control preferences
    • Time Frame: 1 month after clinical visit
    • 4 item scale where lower scores indicate more positive outcomes from screening
  • Decisional conflict Scale
    • Time Frame: 1 month after clinical visit
    • 16 item scale ranging in a score from 0-4 where higher scores indicate more disagreement
  • Multidimensional measure of informed choice
    • Time Frame: 1 month after clinical visit
    • 10 item true/false scale
  • Decisional regret scale
    • Time Frame: 1 month after clinical visit
    • 5 item questionnaire using 5 point Likert scales where higher scores indicate more disagreement

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 55 Years

Maximum Age: 69 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Case Comprehensive Cancer Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Michael A Brooks, MD, Principal Investigator, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

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