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

NCT03387527 | Completed

• 1 other identifier: CASE7817
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Decision Aid

Outcome Measures

Primary Outcomes (1)

• Number of initial interviews completed in 60 minutes

  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.

  60 minutes from beginning of interview

Secondary Outcomes (5)

• Health Literacy

  1 month after clinical visit

• Patient decisional control preferences

  1 month after clinical visit

• Decisional conflict Scale

  1 month after clinical visit

• Multidimensional measure of informed choice

  1 month after clinical visit

• Decisional regret scale

  1 month after clinical visit

Study Arms (1)

Prostate Cancer Decision Aid

EXPERIMENTAL

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.

Behavioral: Prostate cancer decision aid

Interventions

Prostate cancer decision aid 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

Also known as: screening decision aid

Prostate Cancer Decision Aid

Eligibility Criteria

• Age: 55 Years - 69 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Michael A Brooks, MD

  Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2017
• First Posted: January 2, 2018
• Study Start: February 1, 2018
• Primary Completion: October 3, 2018
• Study Completion: November 3, 2018
• Last Updated: October 24, 2019

Record last verified: 2019-10

Locations

US (1)