Not provided
Not provided
Not provided
Not provided
Not provided
Unable to recruit due to COVID limitations / Funding Unavailable
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Men over 40: Screening with intervention | Experimental | 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. |
|
| Men 18-39: Educational intervention | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Intervention | Other | Attend 10-20 minute PowerPoint presentation that will discuss prostate cancer facts, screening guidelines, risks, benefits, and consequences |
|
| 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 |
| Measure | Description | 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 | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Samir Abraksia, MD | Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106-5065 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| digital rectal examination | Procedure | 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 |
|
|
| Pre-test administration | Other | 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 | Other | Survey will be administered at the end of the program for participants to assess their experience |
|
|
| Prostate-specific antigen measurement | Other | 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 | Other | Post test will include the same 15 questions as on the pretest to assess for improvement in knowledge and understanding |
|
|
| 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 |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| D008722 | Methods |
| D015397 | Program Evaluation |
| D017430 | Prostate-Specific Antigen |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D008919 | Investigative Techniques |
| D005069 | Evaluation Studies as Topic |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017531 | Health Care Evaluation Mechanisms |
| D017530 | Health Care Quality, Access, and Evaluation |
| D007610 | Kallikreins |
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D029584 | Prostatic Secretory Proteins |
| D029589 | Seminal Plasma Proteins |
| D000094664 | Seminal Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000951 | Antigens, Neoplasm |
| D000941 | Antigens |
| D001685 | Biological Factors |
| D014408 | Biomarkers, Tumor |
| D015415 | Biomarkers |
Not provided
Not provided