Clinical trial NCT02419846: 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
Overall status: TERMINATED
Phase: NA
Conditions: Prostate Carcinoma
Keywords: Informed Decision Making
Prostate
Cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2015-04-17
Enrollment: 319
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Proportion of participants over age 18 that demonstrate improved knowledge about prostate cancer screening
timeFrame: Up to 1 year
measure: 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
timeFrame: Up to 1 year
Secondary outcomes:
measure: Proportion of participants who choose to enter the clinical trial
timeFrame: Up to 1 year
measure: Proportion of participants who choose screening after educational intervention
timeFrame: Up to 1 year
measure: 10-year expected mortality based on USCF 10-year Mortality Index for all participants
timeFrame: Up to 1 year
measure: Proportion of participants with a high 10-year mortality based on UCSF index who choose to be screened for prostate cancer after educational intervention
timeFrame: Up to 1 year
measure: Proportion of abnormal results found with screening and referred to follow-up assessed as per National Comprehensive Cancer Network guidelines
timeFrame: Up to 1 year
measure: Proportion of participants diagnosed with malignancy based on follow up biopsies and work-up during the course of the study
timeFrame: Up to 1 year
measure: Proportion of participants with family history of prostate cancer
timeFrame: Up to 1 year
measure: Proportion of participants referred to a primary care physician who did not previously have a primary care physician
timeFrame: Up to 1 year
measure: Proportion of participants who asked the physician to make a decision for them in spite of educational intervention
timeFrame: Up to 1 year
measure: Proportion of participants who expressed satisfied with this proposed informed consent and education model
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
name: Samir Abraksia, MD
role: PRINCIPAL_INVESTIGATOR
References: