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

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ClinicalTrials.gov Identifier: NCT03387527
Recruitment Status : Not yet recruiting
First Posted : January 1, 2018
Last Update Posted : January 1, 2018
Sponsor:
Information provided by (Responsible Party):

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. We are evaluating whether or not patients find this screening decision aid helpful. As part of this study, you will be asked for your response on questionnaires. Since we are interested in your opinion, there are no wrong answers.

If patients find the screening decision aid helpful, we will make it available at other clinic locations.


Condition or disease Intervention/treatment
Prostate Cancer Behavioral: Prostate cancer decision aid

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Using Decision Analysis to Enhance Decision-Making Regarding Prostate Cancer Screening
Anticipated Study Start Date : January 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 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.
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
Other Name: screening decision aid


Outcome Measures

Primary Outcome Measures :
  1. Number of initial interviews completed in 60 minutes [ Time Frame: 60 minutes from beginning of interview ]
    To be considered feasible in a busy clinical setting, we anticipate 80% of the initial interviews to be completed within the allotted 60-minute interview time.


Secondary Outcome Measures :
  1. Health Literacy [ Time Frame: 1 month after clinical visit ]
    Five item scale measuring attitudes towards screening

  2. Patient decisional control preferences [ Time Frame: 1 month after clinical visit ]
    4 item scale where lower scores indicate more positive outcomes from screening

  3. Decisional conflict Scale [ Time Frame: 1 month after clinical visit ]
    16 item scale ranging in a score from 0-4 where higher scores indicate more disagreement

  4. Multidimensional measure of informed choice [ Time Frame: 1 month after clinical visit ]
    10 item true/false scale

  5. Decisional regret scale [ Time Frame: 1 month after clinical visit ]
    5 item questionnaire using 5 point Likert scales where higher scores indicate more disagreement


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03387527


Contacts
Contact: Andrew Stephenson, MD 866-223-8100 CancerCenterResearch@ccf.org

Locations
United States, Ohio
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center Not yet recruiting
Cleveland, Ohio, United States, 44195
Contact: Andew Stephenson, MD    216-445-1062      
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Andrew Stephenson, MD Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
More Information

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03387527     History of Changes
Other Study ID Numbers: CASE7817
First Posted: January 1, 2018    Key Record Dates
Last Update Posted: January 1, 2018
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Case Comprehensive Cancer Center:
Decision Aid

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases