NCT03197896

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
239

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 29, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 23, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2018

Completed
7.7 years until next milestone

Results Posted

Study results publicly available

March 25, 2026

Completed
Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

1.8 years

First QC Date

June 22, 2017

Results QC Date

December 7, 2020

Last Update Submit

March 24, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in Prostate Cancer Knowledge as Measured by the Decisional Conflict Scale

    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."

    4 months

  • Intent to Screen for PCa

    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.

    baseline to 4 months

Study Arms (2)

Group I (prostate cancer information)

EXPERIMENTAL

The educator reviews general information about the prostate Cancer

Other: Educational Intervention

Group II (general health information)

ACTIVE COMPARATOR

The educator reviews topics about health promotion actions.

Other: Educational Intervention

Interventions

Review prostate cancer information

Group I (prostate cancer information)Group II (general health information)

Eligibility Criteria

Age40 Years - 69 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

MeSH Terms

Interventions

Early Intervention, Educational

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Results Point of Contact

Title
Dr. Charnita Ziegler Johnson
Organization
Thomas Jefferson University

Study Officials

  • Charnita Zeigler-Johnson, MPH, PhD

    Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2017

First Posted

June 23, 2017

Study Start

September 29, 2016

Primary Completion

July 20, 2018

Study Completion

July 20, 2018

Last Updated

March 25, 2026

Results First Posted

March 25, 2026

Record last verified: 2026-03

Locations