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

Primary Purpose

Prostate Carcinoma

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Educational Intervention

digital rectal examination

Pre-test administration

Survey Administration

Prostate-specific antigen measurement

Post test administration

About this trial

This is an interventional screening trial for Prostate Carcinoma focused on measuring Informed Decision Making, Prostate, Cancer

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)MaleAccepts 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

Sites / Locations

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Men over 40: Screening with intervention

Men 18-39: Educational intervention

Arm 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.

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.

Outcomes

Primary Outcome Measures

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%.

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.

Secondary Outcome Measures

Proportion of participants who choose to enter the clinical trial

Proportion of participants who choose screening after educational intervention

10-year expected mortality based on USCF 10-year Mortality Index for all participants

Proportion of participants with a high 10-year mortality based on UCSF index who choose to be screened for prostate cancer after educational intervention

Proportion of abnormal results found with screening and referred to follow-up assessed as per National Comprehensive Cancer Network guidelines

Proportion of participants diagnosed with malignancy based on follow up biopsies and work-up during the course of the study

Proportion of participants with family history of prostate cancer

Proportion of participants referred to a primary care physician who did not previously have a primary care physician

Proportion of participants who asked the physician to make a decision for them in spite of educational intervention

Proportion of participants who expressed satisfied with this proposed informed consent and education model

Full Information

NCT ID

NCT02419846

First Posted

April 14, 2015

Last Updated

July 21, 2022

Sponsor

Case Comprehensive Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT02419846

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Terminated

Why Stopped

Unable to recruit due to COVID limitations / Funding Unavailable

Study Start Date

June 1, 2015 (Actual)

Primary Completion Date

October 2021 (Actual)

Study Completion Date

July 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Case Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Carcinoma

Keywords

Informed Decision Making, Prostate, Cancer

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

319 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Men over 40: Screening with intervention

Arm Type

Experimental

Arm Description

Arm Title

Men 18-39: Educational intervention

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Educational Intervention

Other Intervention Name(s)

PowerPoint Presentation, Intervention, Educational

Intervention Description

Attend 10-20 minute PowerPoint presentation that will discuss prostate cancer facts, screening guidelines, risks, benefits, and consequences

Intervention Type

Procedure

Intervention Name(s)

digital rectal examination

Other Intervention Name(s)

DRE

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Pre-test administration

Other Intervention Name(s)

questionnaire administration

Intervention Description

15 questions which test participants' knowledge of prostate cancer according to ACS guidelines. Questions will be multiple choices and true/false/unsure answers

Intervention Type

Other

Intervention Name(s)

Survey Administration

Other Intervention Name(s)

Program Evaluation

Intervention Description

Survey will be administered at the end of the program for participants to assess their experience

Intervention Type

Other

Intervention Name(s)

Prostate-specific antigen measurement

Other Intervention Name(s)

PSA levels

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Post test administration

Other Intervention Name(s)

questionnaire administration

Intervention Description

Post test will include the same 15 questions as on the pretest to assess for improvement in knowledge and understanding

Primary Outcome Measure Information:

Title

Proportion of participants over age 18 that demonstrate improved knowledge about prostate cancer screening

Description

Time Frame

Up to 1 year

Title

Description

Helpfulness of the program will be measured on a 5-point Likert scale where the two uppermost categories are considered a positive response.

Time Frame

Up to 1 year

Secondary Outcome Measure Information:

Title

Proportion of participants who choose to enter the clinical trial

Time Frame

Up to 1 year

Title

Proportion of participants who choose screening after educational intervention

Time Frame

Up to 1 year

Title

10-year expected mortality based on USCF 10-year Mortality Index for all participants

Time Frame

Up to 1 year

Title

Proportion of participants with a high 10-year mortality based on UCSF index who choose to be screened for prostate cancer after educational intervention

Time Frame

Up to 1 year

Title

Proportion of abnormal results found with screening and referred to follow-up assessed as per National Comprehensive Cancer Network guidelines

Time Frame

Up to 1 year

Title

Proportion of participants diagnosed with malignancy based on follow up biopsies and work-up during the course of the study

Time Frame

Up to 1 year

Title

Proportion of participants with family history of prostate cancer

Time Frame

Up to 1 year

Title

Proportion of participants referred to a primary care physician who did not previously have a primary care physician

Time Frame

Up to 1 year

Title

Proportion of participants who asked the physician to make a decision for them in spite of educational intervention

Time Frame

Up to 1 year

Title

Proportion of participants who expressed satisfied with this proposed informed consent and education model

Time Frame

Up to 1 year

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Samir Abraksia, MD

Organizational Affiliation

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106-5065

Country

United States

12. IPD Sharing Statement

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

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