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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prostate cancer decision aid
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Cancer focused on measuring Decision Aid

Eligibility Criteria

55 Years - 69 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prostate Cancer Decision Aid

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
December 22, 2017
Last Updated
October 23, 2019
Sponsor
Case Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT03387527
Brief Title
Using Decision Analysis to Enhance Decision-Making Regarding Prostate Cancer Screening
Official Title
Using Decision Analysis to Enhance Decision-Making Regarding Prostate Cancer Screening
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
October 3, 2018 (Actual)
Study Completion Date
November 3, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Decision Aid

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prostate Cancer Decision Aid
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Prostate cancer decision aid
Other Intervention Name(s)
screening decision aid
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of initial interviews completed in 60 minutes
Description
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.
Time Frame
60 minutes from beginning of interview
Secondary Outcome Measure Information:
Title
Health Literacy
Description
Five item scale measuring attitudes towards screening
Time Frame
1 month after clinical visit
Title
Patient decisional control preferences
Description
4 item scale where lower scores indicate more positive outcomes from screening
Time Frame
1 month after clinical visit
Title
Decisional conflict Scale
Description
16 item scale ranging in a score from 0-4 where higher scores indicate more disagreement
Time Frame
1 month after clinical visit
Title
Multidimensional measure of informed choice
Description
10 item true/false scale
Time Frame
1 month after clinical visit
Title
Decisional regret scale
Description
5 item questionnaire using 5 point Likert scales where higher scores indicate more disagreement
Time Frame
1 month after clinical visit

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael A Brooks, MD
Organizational Affiliation
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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