Informed Decision Making Intervention in Screening for Prostate Cancer of Predominantly African American Participants in a Community Outreach Program
NCT ID: NCT02419846
Last Updated: 2022-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
319 participants
INTERVENTIONAL
2015-06-01
2022-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Dissemination of Prostate Cancer Screening to PCP's in African American Communities
NCT00629330
Prostate Cancer Education in African American Men
NCT01415375
Tumor Genomic Pre-test Counseling Tool for Black or African-American Men With Prostate Cancer
NCT06171139
Educate, Assess Risk and Overcoming Barriers to Colorectal Screening Among African Americans
NCT03640208
A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men
NCT06052202
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
(A) To assess the effectiveness of a proposed educational model for informed decision about Prostate Cancer in high risk men over age 40 which compares informed decision making and shared decision making (B) to improve knowledge about prostate cancer in men over age 18
OUTLINE:
Participants complete an educational intervention comprising a 10-20 minute PowerPoint presentation given by an experienced healthcare professional that discusses prostate cancer facts, screening guidelines, risks, benefits, and consequences. Some participants then undergo a screening exam comprising a prostate specific antigen level and digital rectal exam.
After completion of study, participants are followed up periodically.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Men over 40: Screening with intervention
Participants over the age of 40 complete an educational intervention comprising a 10-20 minute PowerPoint presentation given by an experienced healthcare professional that discusses prostate cancer facts, screening guidelines, risks, benefits, and consequences. Participants may undergo a screening exam comprising a prostate specific antigen level and digital rectal exam.
Educational Intervention
Attend 10-20 minute PowerPoint presentation that will discuss prostate cancer facts, screening guidelines, risks, benefits, and consequences
digital rectal examination
Undergo digital rectal exam by a licensed healthcare professional. The results of this exam will be subjective as per clinician; however, will be coded as normal or abnormal. This is considered standard of care for prostate cancer screening
Pre-test administration
15 questions which test participants' knowledge of prostate cancer according to ACS guidelines. Questions will be multiple choices and true/false/unsure answers
Survey Administration
Survey will be administered at the end of the program for participants to assess their experience
Prostate-specific antigen measurement
PSA levels will be drawn and run as per institutional Laboratory standards. Criteria for referral and follow up will be assessed as per National Comprehensive Cancer Network (NCCN) guidelines
Post test administration
Post test will include the same 15 questions as on the pretest to assess for improvement in knowledge and understanding
Men 18-39: Educational intervention
Participants between 18 and 39 complete an educational intervention comprising a 10-20 minute PowerPoint presentation given by an experienced healthcare professional that discusses prostate cancer facts, screening guidelines, risks, benefits, and consequences.
Educational Intervention
Attend 10-20 minute PowerPoint presentation that will discuss prostate cancer facts, screening guidelines, risks, benefits, and consequences
Pre-test administration
15 questions which test participants' knowledge of prostate cancer according to ACS guidelines. Questions will be multiple choices and true/false/unsure answers
Survey Administration
Survey will be administered at the end of the program for participants to assess their experience
Post test administration
Post test will include the same 15 questions as on the pretest to assess for improvement in knowledge and understanding
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Educational Intervention
Attend 10-20 minute PowerPoint presentation that will discuss prostate cancer facts, screening guidelines, risks, benefits, and consequences
digital rectal examination
Undergo digital rectal exam by a licensed healthcare professional. The results of this exam will be subjective as per clinician; however, will be coded as normal or abnormal. This is considered standard of care for prostate cancer screening
Pre-test administration
15 questions which test participants' knowledge of prostate cancer according to ACS guidelines. Questions will be multiple choices and true/false/unsure answers
Survey Administration
Survey will be administered at the end of the program for participants to assess their experience
Prostate-specific antigen measurement
PSA levels will be drawn and run as per institutional Laboratory standards. Criteria for referral and follow up will be assessed as per National Comprehensive Cancer Network (NCCN) guidelines
Post test administration
Post test will include the same 15 questions as on the pretest to assess for improvement in knowledge and understanding
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Educational component: men over the age of 18
* Screening component: men over age 40
Exclusion Criteria
* Active malignancy, metastatic disease, or anyone undergoing treatment for malignancy
19 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Case Comprehensive Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Samir Abraksia, MD
Role: PRINCIPAL_INVESTIGATOR
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CASE3815
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.