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

Case Comprehensive Cancer Center (Case CCC)

Status: Terminated

Conditions: Prostate Carcinoma

Treatments: Procedure: digital rectal examination; Other: Survey Administration; Other: Post test administration; Other: Prostate-specific antigen measurement; Other: Educational Intervention; Other: Pre-test administration

Study type: Interventional

Funder types: Other

Identifiers

NCT02419846

CASE3815

Details and patient eligibility

About

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.

Full 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.

Enrollment: 319 patients

Sex: Male

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Men over the age of 18 will be asked to participate in the educational component of the program; men over the age of 40 will be offered the screening component after the educational portion of the event; participants over age of 40 will have the opportunity to make an informed decision in regards to prostate cancer screening based on this information and the educational material; American Cancer Society (ACS) guidelines recommend having a discussion about screening in men who have an expected mortality of greater than 10 years; data on comorbidities and 10-year mortalities will be collected on every participant using the University of California at San Francisco (UCSF) mortality index
• Educational component: men over the age of 18
• Screening component: men over age 40

Exclusion criteria

• Known personal history of prostate cancer
• Active malignancy, metastatic disease, or anyone undergoing treatment for malignancy

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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319 participants in 2 patient groups

Men over 40: Screening with intervention

Experimental group

Description:

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.

Treatment:

Other: Pre-test administration

Other: Prostate-specific antigen measurement

Other: Educational Intervention

Other: Post test administration

Other: Survey Administration

Procedure: digital rectal examination

Men 18-39: Educational intervention

Experimental group

Description:

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.

Treatment:

Other: Pre-test administration

Other: Educational Intervention

Other: Post test administration

Other: Survey Administration