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

Not Applicable

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT03387527
• Lead Sponsor: Case Comprehensive Cancer Center

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.

Study Timeline

• Study First Submitted: 2017-12-22
• Study First Submitted QC: 2017-12-22
• Study First Posted: 2018-01-02
• Study Start: 2018-02-01
• Primary Completion: 2018-10-03
• Study Completion: 2018-11-03
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-23
• Last Update Posted: 2019-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of initial interviews completed in 60 minutes	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 Outcome Measures

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

Trial Locations

Locations (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States