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A quality improvement initiative to improve rates of germline testing among men with prostate cancer through the use of an in-clinic educational session.
This is a prospective single arm quality improvement initiative for the use of a standardized educational intervention on germline testing in prostate cancer to improve the rates of germline genetic testing among patients recommended for testing. Patients who consent to the study will undergo a one-on-one education session regarding the rationale and the benefits/risks of germline testing. Following the educational session, if a patient wishes to proceed with testing, they will sign the standard consent to proceed with germline testing via a commercial assay.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Educational intervention | Other | In-clinic or virtual educational session on germline testing in prostate cancer with a trained educator. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational intervention. | Behavioral | Educational intervention with trained educator on overview, rationale, implications, and risks and benefits of germline testing in prostate cancer. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Agreeing to Proceed With Germline Testing Among Those Approached With the Educational Intervention. | Germline genetic testing among adult prostate cancer patients who are recommended to receive germline testing per NCCN guidelines. | Within 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Baseline Knowledge of Germline Testing | Assessment via baseline knowledge questionnaire. Survey Title: Patient Survey on Germline Testing in Prostate Cancer Minimum Values: 0 (No knowledge) Maximum Values: 11 (Highest knowledge) Higher score = higher knowledge | Baseline |
| Patient Attitudes Towards Germline Testing and Assess the Impact of an Education Interventional on Patient Perceptions of Germline Testing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rana McKay, MD | UCSD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego | La Jolla | California | 92037 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Video Intervention Group | All patients were enrolled to the video intervention group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Education Intervention Group | In-clinic educational session on germline testing in prostate cancer with a trained educator including video intervention. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age |
| 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 | Number of Participants Agreeing to Proceed With Germline Testing Among Those Approached With the Educational Intervention. | Germline genetic testing among adult prostate cancer patients who are recommended to receive germline testing per NCCN guidelines. | Posted | Count of Participants | Participants | Within 1 year |
|
|
within 18 months
Adverse events
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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 | Education Intervention Group | In-clinic educational session on germline testing in prostate cancer with a trained educator including video intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rana McKay, MD | University of California, San Diego | (858) 822-5354 | CancerCTO@health.ucsd.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 | Dec 6, 2021 | Dec 2, 2025 | Prot_SAP_000.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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Assessment via post intervention questionnaire. Survey Title: Patient Post-Education Patient Survey Minimum Values: 0 (No knowledge) Maximum Values: 11 (Highest knowledge) Higher score = higher knowledge |
| Within 18 months |
| Number of Participants With Pathogenic Germline Mutations | Assessment via tabulation of all germline pathogenic, likely pathogenic mutations and and variants of uncertain significance. | within 18 months |
| Patient Knowledge of Germline Testing After the Educational Intervention. | Assessment via post intervention knowledge questionnaire. Survey Title: Patient Survey on Germline Testing in Prostate Cancer Minimum Values: 0 (No knowledge) Maximum Values: 11 (Highest knowledge) Higher score = higher knowledge | within 18 months |
| Full Range |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Family history | Count of Participants | Participants |
|
|
| Secondary | Patient Baseline Knowledge of Germline Testing | Assessment via baseline knowledge questionnaire. Survey Title: Patient Survey on Germline Testing in Prostate Cancer Minimum Values: 0 (No knowledge) Maximum Values: 11 (Highest knowledge) Higher score = higher knowledge | Posted | Mean | Full Range | Units on a scale | Baseline |
|
|
|
| Secondary | Patient Attitudes Towards Germline Testing and Assess the Impact of an Education Interventional on Patient Perceptions of Germline Testing | Assessment via post intervention questionnaire. Survey Title: Patient Post-Education Patient Survey Minimum Values: 0 (No knowledge) Maximum Values: 11 (Highest knowledge) Higher score = higher knowledge | Posted | Mean | Full Range | Units on a scale | Within 18 months |
|
|
|
| Secondary | Number of Participants With Pathogenic Germline Mutations | Assessment via tabulation of all germline pathogenic, likely pathogenic mutations and and variants of uncertain significance. | Posted | Count of Participants | Participants | within 18 months |
|
|
|
| Secondary | Patient Knowledge of Germline Testing After the Educational Intervention. | Assessment via post intervention knowledge questionnaire. Survey Title: Patient Survey on Germline Testing in Prostate Cancer Minimum Values: 0 (No knowledge) Maximum Values: 11 (Highest knowledge) Higher score = higher knowledge | Posted | Mean | Full Range | units on a scale | within 18 months |
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| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
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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 |