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| Name | Class |
|---|---|
| University of Texas Southwestern Medical Center | OTHER |
| Barbara Ann Karmanos Cancer Institute | OTHER |
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This randomized controlled trial aims to evaluate the impact of pre-test video education and post-test genetic counseling as compared to in-person pre-test genetic counseling in males with advanced prostate cancer.
Participants will be randomized to either pre-test video education and post-test genetic counseling or in-person pre-test genetic counseling. Outcomes evaluated are: prevalence of germline mutations, uptake of genetic testing, satisfaction with testing, knowledge of multi-gene panels, distress, result disclosure to relatives, and the impact on personal or family medical care. Through this study, the investigators will learn about the inherited causes of prostate cancer, and how and when genetic testing should be offered to this population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional pre-test genetic counseling | Active Comparator |
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| Pre-test video education | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traditional pre-test genetic counseling | Other | Participant meets with a genetic counselor at the Center for Cancer Genetics and Prevention and traditional pre-test cancer genetic counseling is provided |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of germline mutations in males with prostate cancer | The proportion of participants who test positive for pathogenic or likely pathogenic variants | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Genetic testing uptake | The proportion of participants who consent to genetic testing in the pre-test video education arm | 2 years |
| Secondary or other primary (non-prostate) malignancies | Assessed by chart review. Participants with positive genetic test results will fill out the "Positive Test Results" Survey to report any additional cancer diagnoses. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huma Q Rana, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States | ||
| Barbara Ann Karmanos Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37733980 | Derived | Rana HQ, Stopfer JE, Weitz M, Kipnis L, Koeller DR, Culver S, Mercado J, Gelman RS, Underhill-Blazey M, McGregor BA, Sweeney CJ, Petrucelli N, Kokenakes C, Pirzadeh-Miller S, Reys B, Frazier A, Knechtl A, Fateh S, Vatnick DR, Silver R, Kilbridge KE, Pomerantz MM, Wei XX, Choudhury AD, Sonpavde GP, Kozyreva O, Lathan C, Horton C, Dolinsky JS, Heath EI, Ross TS, Courtney KD, Garber JE, Taplin ME. Pretest Video Education Versus Genetic Counseling for Patients With Prostate Cancer: ProGen, A Multisite Randomized Controlled Trial. JCO Oncol Pract. 2023 Nov;19(11):1069-1079. doi: 10.1200/OP.23.00007. Epub 2023 Sep 21. | |
| 36103646 |
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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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| Pre-test video education | Other | The video is designed to mirror the educational components of a traditional genetic counseling visit |
|
| 2 years |
| Genetic testing satisfaction score | A validated survey of participants' satisfaction with the genetic counseling and testing process will be used. For the survey at the time of post-counseling, the survey for the video education arm consists of 8 questions and the genetic counseling arm contains an additional question about perceived length of the visit. The parameters for measurement are "disagree strongly", "disagree", "neither agree or disagree", "agree", and "agree strongly". At the time of 1 month post-result disclosure, an additional set of 5 questions will be added. Four of these five questions will be evaluated using the previously described parameters. The remaining question will be answered by the response options: "yes", "no", or "I did not get the packet". Survey responses will be re-coded on a numerical scale consistent with the standard Likert scale. | at time of post-counseling/video pre-result disclosure and at 1 month post-result disclosure |
| Multidimensional Impact of Cancer Risk Assessment score and subscales | MICRA is a widely used validated 25-item measure that assesses psychosocial consequences associated with genetic testing for cancer. Section 1 contains 3 sub-scales: the Positive sub-scale (4 items), the Distress sub-scale (6 items), and the Uncertainty sub-scale (9 items) and two other items that do not fit into either sub-scale. Section 2 contains two items for participants who have children. Section 3 contains 2 items for participants who have/have had cancer. Responses are indicated on a 4 point scale for experiences in the past week. A higher score in the sub-scales or total scale indicated greater distress. The positive sub-scale is reverse scored to reflect this. | 1 and 4 months post-result disclosure |
| Knowledge of multigene panel testing score | A 24 item investigator-developed knowledge scale applicable to this population was developed through an expert panel and in-depth patient cognitive interviews to determine if participants are able to recall key core components about multi-gene panel testing. Each item provides three choice answers: "agree", "disagree", or "I don't know". Knowledge will be scored on the number of "correct" responses where higher correct responses represents more knowledge of multigene panel testing. | 4 months post-result disclosure |
| Family communication for those who tested positive for a genetic mutation | For those participants who have tested positive for a mutation, 5 items will be asked pertaining to disclosure of genetic testing results to relatives that are derived from previous literature. | 1 and 4 months post-result disclosure |
| Intent to disclose genetic test results | Three items will assess participants' intentions to disclose genetic testing results. | pre-result disclosure |
| Detroit |
| Michigan |
| 48201 |
| United States |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Derived |
| Berchuck JE, Boiarsky D, Silver R, Sunkara R, McClure HM, Tsai HK, Siegmund S, Tewari AK, Nowak JA, Lindeman NI, Rana HQ, Choudhury AD, Pomerantz MM, Freedman ML, Van Allen EM, Taplin ME. Addition of Germline Testing to Tumor-Only Sequencing Improves Detection of Pathogenic Germline Variants in Men With Advanced Prostate Cancer. JCO Precis Oncol. 2022 Aug;6:e2200329. doi: 10.1200/PO.22.00329. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |