Educational Intervention in Increasing Knowledge About Prostate Cancer in High-Risk Neighborhoods

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.

• Educational Intervention (Other): Review prostate cancer information

Primary outcomes

• 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.

Sex: Male, ages: 40 Years to 69 Years

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

Participant flow

Outcome results

• Change in Prostate Cancer Knowledge as Measured by the Decisional Conflict Scale (Primary), Median, score on a scale: Group I (Prostate Cancer Information) 80 (40 to 100); Group II (General Health Information) 70 (40 to 100)
• Intent to Screen for PCa (Primary), Mean, Scores on a Scale (1-5): Group I (Prostate Cancer Information) 0.91 (0.49 to 1.32); Group II (General Health Information) 0.78 (0.40 to 1.16)

Adverse events

Time frame: reporting for adverse events was done for participants during active participation and for 4 months following completion

• Study Protocol and Statistical Analysis Plan (PDF, 2015-05-28)
• Informed Consent Form (PDF, 2016-05-12)

• Charnita Zeigler-Johnson, MPH, PhD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University