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

Prostate Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02419846
• Other study ID #: CASE3815
• Status: Terminated
• Phase: N/A
• Start date: June 1, 2015
• Est. completion date: July 2022

Study information

• Verified date: July 2022
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 319
• Est. completion date: July 2022
• Est. primary completion date: October 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Carcinoma
• Prostatic Neoplasms

Intervention

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
• 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

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	Proportion of participants over age 18 that demonstrate improved knowledge about prostate cancer screening	Improved understanding will be defined as an increase in the number of correct answers seen on the post Prostate Screening Education Questionnaire. The underlying likelihood of a positive response, or improved understanding of prostate cancer screening, can be estimated using a 95% confidence interval that has a maximum half-width of 6%.	Up to 1 year
Primary	Proportion of participants over age 40 who find this education and screening model helpful in making an informed decision about prostate cancer screening as measured by the satisfaction survey questions	Helpfulness of the program will be measured on a 5-point Likert scale where the two uppermost categories are considered a positive response.	Up to 1 year
Secondary	Proportion of participants who choose to enter the clinical trial		Up to 1 year
Secondary	Proportion of participants who choose screening after educational intervention		Up to 1 year
Secondary	10-year expected mortality based on USCF 10-year Mortality Index for all participants		Up to 1 year
Secondary	Proportion of participants with a high 10-year mortality based on UCSF index who choose to be screened for prostate cancer after educational intervention		Up to 1 year
Secondary	Proportion of abnormal results found with screening and referred to follow-up assessed as per National Comprehensive Cancer Network guidelines		Up to 1 year
Secondary	Proportion of participants diagnosed with malignancy based on follow up biopsies and work-up during the course of the study		Up to 1 year
Secondary	Proportion of participants with family history of prostate cancer		Up to 1 year
Secondary	Proportion of participants referred to a primary care physician who did not previously have a primary care physician		Up to 1 year
Secondary	Proportion of participants who asked the physician to make a decision for them in spite of educational intervention		Up to 1 year
Secondary	Proportion of participants who expressed satisfied with this proposed informed consent and education model		Up to 1 year