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

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.

Study Overview

• Status: Terminated
• Conditions: Prostate Carcinoma
• Intervention / Treatment: Other: Educational Intervention; Procedure: digital rectal examination; Other: Pre-test administration; Other: Survey Administration; Other: Prostate-specific antigen measurement; Other: Post test administration

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.

• Study Type: Interventional
• Enrollment (Actual): 319
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106-5065
      • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Educational Intervention; Attend 10-20 minute PowerPoint presentation that will discuss prostate cancer facts, screening guidelines, risks, benefits, and consequences; Other Names: Intervention, Educational; PowerPoint Presentation; 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 Names: DRE; 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 Names: questionnaire administration; Other: Survey Administration; Survey will be administered at the end of the program for participants to assess their experience; Other Names: Program Evaluation; 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 Names: PSA levels; Other: Post test administration; Post test will include the same 15 questions as on the pretest to assess for improvement in knowledge and understanding; Other Names: questionnaire administration
Experimental: 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.	Other: Educational Intervention; Attend 10-20 minute PowerPoint presentation that will discuss prostate cancer facts, screening guidelines, risks, benefits, and consequences; Other Names: Intervention, Educational; PowerPoint Presentation; 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 Names: questionnaire administration; Other: Survey Administration; Survey will be administered at the end of the program for participants to assess their experience; Other Names: Program Evaluation; Other: Post test administration; Post test will include the same 15 questions as on the pretest to assess for improvement in knowledge and understanding; Other Names: questionnaire administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Time Frame
Proportion of participants who choose to enter the clinical trial	Up to 1 year
Proportion of participants who choose screening after educational intervention	Up to 1 year
10-year expected mortality based on USCF 10-year Mortality Index for all participants	Up to 1 year
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
Proportion of abnormal results found with screening and referred to follow-up assessed as per National Comprehensive Cancer Network guidelines	Up to 1 year
Proportion of participants diagnosed with malignancy based on follow up biopsies and work-up during the course of the study	Up to 1 year
Proportion of participants with family history of prostate cancer	Up to 1 year
Proportion of participants referred to a primary care physician who did not previously have a primary care physician	Up to 1 year
Proportion of participants who asked the physician to make a decision for them in spite of educational intervention	Up to 1 year
Proportion of participants who expressed satisfied with this proposed informed consent and education model	Up to 1 year

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Samir Abraksia, MD, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): October 1, 2021
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: April 14, 2015
• First Submitted That Met QC Criteria: April 14, 2015
• First Posted (Estimate): April 17, 2015

Study Record Updates

• Last Update Posted (Actual): July 25, 2022
• Last Update Submitted That Met QC Criteria: July 21, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Cancer; Prostate; Informed Decision Making
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: CASE3815

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No