Informed Decision Making Intervention in Screening for Prostate Cancer of Predominantly African American Participants in a Community Outreach Program
- Conditions
- Prostate Carcinoma
- Interventions
- Other: Educational InterventionProcedure: digital rectal examinationOther: Pre-test administrationOther: Survey AdministrationOther: Post test administrationOther: Prostate-specific antigen measurement
- Registration Number
- NCT02419846
- Lead Sponsor
- Case Comprehensive Cancer Center
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 319
- 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
- Known personal history of prostate cancer
- Active malignancy, metastatic disease, or anyone undergoing treatment for malignancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Men over 40: Screening with intervention Educational 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. Men over 40: Screening with intervention digital rectal examination 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 over 40: Screening with intervention Pre-test administration 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 over 40: Screening with intervention Survey Administration 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 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. Men 18-39: Educational intervention Post test administration 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. Men 18-39: Educational intervention Pre-test administration 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. Men over 40: Screening with intervention Prostate-specific antigen measurement 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 over 40: Screening with intervention Post test administration 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 Survey Administration 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.
- Primary Outcome Measures
Name Time Method Proportion of participants over age 18 that demonstrate improved knowledge about prostate cancer screening Up to 1 year 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 Up to 1 year 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
Name Time Method Proportion of participants who choose screening after educational intervention 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 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 with family history of prostate cancer Up to 1 year Proportion of participants who choose to enter the clinical trial 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 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 who expressed satisfied with this proposed informed consent and education model Up to 1 year 10-year expected mortality based on USCF 10-year Mortality Index for all participants Up to 1 year
Trial Locations
- Locations (1)
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States