Prostate
Conditions
Brief summary
This clinical trial studies how well an educational intervention works in increasing knowledge about prostate cancer in high-risk neighborhoods. Learning about prostate cancer and the pros and cons of screening for prostate cancer may increase knowledge about prostate cancer while decreasing anxiety and concerns about prostate cancer screening.
Detailed description
PRIMARY OBJECTIVES: I. To identify neighborhoods with disproportionately high rates of advanced prostate cancer and describe patient- and neighborhood-level risk factors associated with the high-risk neighborhoods. II. To develop, using a mixed methods approach, a targeted educational intervention about prostate cancer for men who live in high risk neighborhoods. III. To test the impact of the targeted intervention on levels of knowledge, anxiety, and informed decision making about prostate cancer (PCa) screening. IV. To observe the rates of PCa screening in the intervention and control groups.
Interventions
OTHEREducational Intervention
Review prostate cancer information
Sponsors
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
United States Department of Defense
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
* Focus groups consisting of men who live, work, or worship in the 4 predetermined neighborhoods * Currently reside in one of the four selected high risk neighborhoods
Exclusion criteria
• Men who do not reside in one of the four neighborhoods, who self-report that they have previously been diagnosed with prostate cancer, or who have had prostate cancer screening (prostatic specific antigen \[PSA\] or digital rectal examination \[DRE\]) within the past 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Prostate Cancer Knowledge as Measured by the Decisional Conflict Scale | 4 months | The Decisional Conflict Scale (DCS) measures uncertainty in health decision-making. It includes 16 items rated on a 5-point Likert scale. Scores are calculated by averaging item responses and multiplying by 25, yielding a range from 0 (no conflict) to 100 (high conflict). Lower scores indicate greater clarity, confidence, and satisfaction with the decision. Higher scores reflect uncertainty, lack of information/support, and low confidence. The self-efficacy subscale assesses confidence in decision-making with responses like "a lot confident," "a little confident," or "not at all confident." |
| Intent to Screen for PCa | baseline to 4 months | Estimated mean changes from baseline assessment in likelihood of screening by study group from baseline to 4 month follow up. Intent to screen for prostate cancer was measured on a 5 point Likert Scale (1= very unlikely to 5=very likely). Results represent estimated mean change and 95% Confidence Interval from baseline in intent-to-screen score. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCharnita Zeigler-Johnson, MPH, PhD
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 54 Years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 108 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 118 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 118 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 121 | 0 / 118 |
| other Total, other adverse events | 0 / 121 | 0 / 118 |
| serious Total, serious adverse events | 0 / 121 | 0 / 118 |
Outcome results
None listed