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

NCT ID: NCT03387527

Last Updated: 2019-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2018-11-03

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Prostate cancer decision aid

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

Other Intervention Names

screening decision aid

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael A Brooks, MD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Locations

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

CASE7817

Identifier Type: -

Identifier Source: org_study_id