NCT02419846

Informed Decision Making Intervention in Screening for Prostate Cancer of Predominantly African American Participants in a Community Outreach Program

The Effectiveness of a Proposed Prostate Cancer Outreach Program in a Predominantly African American Community That Promotes Informed Decision-making for Prostate Cancer Screening and Utilizes Community Navigation

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 319 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: Male
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

This clinical trial studies an informed decision making intervention of screening for prostate cancer in predominantly African American participants. It also evaluates participants' knowledge about prostate cancer screening and to improve understanding. Using decision aids such as culturally sensitive written material, verbal information, and videos to educate patients about screening may increase patient participation and knowledge. This may increase confidence in participants' decisions. Raising awareness about prostate cancer in the communities may increase the participants' willingness to be screened for prostate cancer once they have learned about it.

Detailed description

PRIMARY OBJECTIVES: (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

• Prostate Carcinoma

Interventions

Type	Name	Description
OTHER	Educational Intervention	Attend 10-20 minute PowerPoint presentation that will discuss prostate cancer facts, screening guidelines, risks, benefits, and consequences
PROCEDURE	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
OTHER	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
OTHER	Survey Administration	Survey will be administered at the end of the program for participants to assess their experience
OTHER	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
OTHER	Post test administration	Post test will include the same 15 questions as on the pretest to assess for improvement in knowledge and understanding

Timeline

• Start date: 2015-06-01
• Primary completion: 2021-10-01
• Completion: 2022-07-01
• First posted: 2015-04-17
• Last updated: 2022-07-25

Locations

1 site across 1 country: United States