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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03387527
• Other study ID #: CASE7817
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: November 3, 2018

Study information

• Verified date: October 2019
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 3, 2018
• Est. primary completion date: October 3, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 55 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

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