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| ID | Type | Description | Link |
|---|---|---|---|
| JT 7860 | Other Identifier | JeffTrial Number | |
| PC140667 | Other Grant/Funding Number | Department of Defense |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (prostate cancer information) | Experimental | The educator reviews general information about the prostate Cancer |
|
| Group II (general health information) | Active Comparator | The educator reviews topics about health promotion actions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Intervention | Other | Review prostate cancer information |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Charnita Zeigler-Johnson, MPH, PhD | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Cancer Center at Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
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| Label | URL |
|---|---|
| Sidney Kimmel Cancer Center | View source |
| Thomas Jefferson University Hospital | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group I (Prostate Cancer Information) | The educator reviews general information about the prostate Cancer Educational Intervention: Review prostate cancer information |
| FG001 | Group II (General Health Information) | The educator reviews topics about health promotion actions. Educational Intervention: Review prostate cancer information |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group I (Prostate Cancer Information) | The educator reviews general information about the prostate Cancer Educational Intervention: Review prostate cancer information |
| BG001 | Group II (General Health Information) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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." | Posted | Median | Full Range | score on a scale | 4 months |
|
reporting for adverse events was done for participants during active participation and for 4 months following completion
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group I (Prostate Cancer Information) | The educator reviews general information about the prostate Cancer Educational Intervention: Review prostate cancer information |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Charnita Ziegler Johnson | Thomas Jefferson University | 215-503-7726 | charnita.ziegler-johnson@jefferson.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 28, 2015 | Dec 22, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 12, 2016 | Dec 14, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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The educator reviews topics about health promotion actions.
Educational Intervention: Review prostate cancer information
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Data on region of enrollment were not collected from any participant in Group I | Count of Participants | Participants |
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| OG001 | Group II (General Health Information) | 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. |
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| Primary | 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. | Posted | Mean | 95% Confidence Interval | Scores on a Scale (1-5) | baseline to 4 months |
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|
| 0 |
| 121 |
| 0 |
| 121 |
| 0 |
| 121 |
| EG001 | Group II (General Health Information) | The educator reviews topics about health promotion actions. Educational Intervention: Review prostate cancer information | 0 | 118 | 0 | 118 | 0 | 118 |
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| D011314 | Preventive Health Services |