Trial Outcomes & Findings for Educational Intervention in Increasing Knowledge About Prostate Cancer in High-Risk Neighborhoods (NCT NCT03197896)
NCT ID: NCT03197896
Last Updated: 2026-03-25
Results Overview
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."
COMPLETED
NA
239 participants
4 months
2026-03-25
Participant Flow
Participant milestones
| Measure |
Group I (Prostate Cancer Information)
The educator reviews general information about the prostate Cancer
Educational Intervention: Review prostate cancer information
|
Group II (General Health Information)
The educator reviews topics about health promotion actions.
Educational Intervention: Review prostate cancer information
|
|---|---|---|
|
Overall Study
STARTED
|
121
|
118
|
|
Overall Study
COMPLETED
|
121
|
118
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data on region of enrollment were not collected from any participant in Group I
Baseline characteristics by cohort
| Measure |
Group I (Prostate Cancer Information)
n=121 Participants
The educator reviews general information about the prostate Cancer
Educational Intervention: Review prostate cancer information
|
Group II (General Health Information)
n=118 Participants
The educator reviews topics about health promotion actions.
Educational Intervention: Review prostate cancer information
|
Total
n=239 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53 Years
n=138 Participants
|
54 Years
n=62 Participants
|
53 Years
n=123 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Sex: Female, Male
Male
|
121 Participants
n=138 Participants
|
118 Participants
n=62 Participants
|
239 Participants
n=123 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Black or African American
|
108 Participants
n=138 Participants
|
112 Participants
n=62 Participants
|
220 Participants
n=123 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=138 Participants
|
2 Participants
n=62 Participants
|
8 Participants
n=123 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=138 Participants
|
4 Participants
n=62 Participants
|
11 Participants
n=123 Participants
|
|
Region of Enrollment
United States
|
121 Participants
n=138 Participants • Data on region of enrollment were not collected from any participant in Group I
|
118 Participants
n=62 Participants • Data on region of enrollment were not collected from any participant in Group I
|
239 Participants
n=123 Participants • Data on region of enrollment were not collected from any participant in Group I
|
PRIMARY outcome
Timeframe: 4 monthsThe 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."
Outcome measures
| Measure |
Group I (Prostate Cancer Information)
n=121 Participants
The educator reviews general information about the prostate Cancer
Educational Intervention: Review prostate cancer information
There are no outcome measures for these focus groups (these were group discussions to gather information about what was desired for the intervention development).
|
Group II (General Health Information)
n=118 Participants
The educator reviews topics about health promotion actions.
Educational Intervention: Review prostate cancer information
Primary Outcome: Prostate cancer knowledge changed from 57% correct at baseline to 71% correct at 4 months after intervention.
|
|---|---|---|
|
Change in Prostate Cancer Knowledge as Measured by the Decisional Conflict Scale
|
80 score on a scale
Interval 40.0 to 100.0
|
70 score on a scale
Interval 40.0 to 100.0
|
PRIMARY outcome
Timeframe: baseline to 4 monthsEstimated 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.
Outcome measures
| Measure |
Group I (Prostate Cancer Information)
n=121 Participants
The educator reviews general information about the prostate Cancer
Educational Intervention: Review prostate cancer information
There are no outcome measures for these focus groups (these were group discussions to gather information about what was desired for the intervention development).
|
Group II (General Health Information)
n=118 Participants
The educator reviews topics about health promotion actions.
Educational Intervention: Review prostate cancer information
Primary Outcome: Prostate cancer knowledge changed from 57% correct at baseline to 71% correct at 4 months after intervention.
|
|---|---|---|
|
Intent to Screen for PCa
|
0.91 Scores on a Scale (1-5)
Interval 0.49 to 1.32
|
0.78 Scores on a Scale (1-5)
Interval 0.4 to 1.16
|
Adverse Events
Group I (Prostate Cancer Information)
Group II (General Health Information)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Charnita Ziegler Johnson
Thomas Jefferson University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place