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| ID | Type | Description | Link |
|---|---|---|---|
| W81XWH1910399 | Other Grant/Funding Number | DOD | |
| JT 14300 | Other Identifier | JeffTrial Number |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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This trial studies how well a peer-based health education program works in reducing barriers and changing attitudes and beliefs of prostate cancer genetic screening in African American participants with or without a previous personal or family history of prostate cancer. Participating in a peer-based health educational program may help participants learn more about prostate cancer and how their personal or family history of disease may increase their risk of prostate cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (health education) | Experimental | Participants attend 1-2 monthly peer educator-led education sessions about PCA genetic testing over 3 hours each for 18 months. |
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| Arm II (cancer educational materials) | Active Comparator | Participants receive mailed informational materials about PCA risk, family history, and genetic testing. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cancer Educational Materials | Behavioral | Receive prostate cancer educational materials |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in of decisional conflict | Will be assessed by the 4-item Sure of myself; Understand information; Risk-benefit ratio; Encouragement (SURE) scale. To compute a summary decisional conflict score, the Likert-scaled responses will be averaged across the SURE item responses provided by a subject completing at least 2 of the 4 questions. The change in decisional conflict scores between baseline and endpoint at 2-months will be calculated and group means for these changes compared between subjects randomized to receive control materials vs. those randomized to receive the peer health education intervention (i.e., by intention to treat). The significance of the difference will be evaluated at the 0.05 level using a two-sided Student's t-test. The assumptions for this test will be carefully evaluated. If the changes are substantially skewed, they will be summarized with group medians and evaluated for significant differences by the nonparametric Wilcoxon's rank sum test. | Baseline up to 2 months |
| Awareness of risks and benefits of genetic testing | Will be summarized in tables with descriptive statistics or graphically in data plots at each time they are assessed along with changes in responses over time. Will investigate imbalances in these data for potential confounding of primary and exploratory endpoint analyses and investigate disparities and intervention effect modification in various subgroups of subjects. | Up to 2 months post study |
| Perceptions of genetic testing | Will be summarized in tables with descriptive statistics or graphically in data plots at each time they are assessed along with changes in responses over time. | Up to 2 months post study |
| Genetic testing | Will be summarized in tables with descriptive statistics or graphically in data plots at each time they are assessed along with changes in responses over time. | Up to 2 months post study |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Cancer Center at Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
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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 | Dec 30, 2022 | Feb 24, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 8, 2021 | Feb 24, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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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| Questionnaire Administration | Other | Ancillary studies |
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| Educational Intervention | Other | Attend peer-led education sessions |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D011314 | Preventive Health Services |