Family Disclosure in Cascade Testing

Study Overview
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Brief Summary
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Prospective cohort study to evaluate the feasibility and acceptability of using standardized educational and communication tools to assist in communication of genetic test results to family members. A pre and post test will be administered to consented patients before and after genetic counseling .

Detailed Description
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This will be a prospective cohort study to evaluate 1) the feasibility and acceptability of using standardized educational and communication tools to assist in communication of genetic test results to family members, 2) utility of the communication tool, and 3) the impact of a patient focused information sheet on the knowledge of genetic testing in women who attend the women's oncology clinic. Genetic counseling is recommended for all women with a diagnosis of ovarian cancer, most patients with pre-menopausal diagnosis of breast cancer, and in younger women with uterine or other gynecologic malignancies. Women with a diagnosis of breast or gynecologic cancer who elect to undergo genetic testing will be approached to participate in this study. If they consent, they will be provided with two information handouts (FORCE sharing worksheets) and family letter template. Participants will complete a baseline knowledge survey prior to receipt of these materials. At a second visit, they will complete the knowledge survey again. Knowledge surveys will be scored and pre and post test scores will be compared with a paired t-test. Feasibility will be assessed by tracking the number of patients approached to participate, the number who sign consents, and the number who complete the study.

Official Title
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Family Disclosure in Cascade Testing

Conditions
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Genetic Predisposition

Intervention / Treatment
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* Other: Feasibility and Acceptability of Genetic Counseling Materials


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 Diagnosis of breast or gynecologic cancer Undergoing any genetic testing at UVA for standard clinical purposes in the Women's Oncology Clinic Exclusion Criteria: Not receiving treatment at UVA Not English literate Unable to provide consent Known pregnancy (self-reported)

Ages Eligible for Study
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Minimum Age: 18 Years


Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Feasibility and Acceptability of Genetic Counseling Materials|To determine the feasibility and acceptability of a communication aid in sharing genetic test results with family members. To determine the utility of a communication aid in sharing information. To determine the impact of patient focused information sheets on patient knowledge of genetic testing.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of family members told in comparison to number of family members | Evaluate the feasibility and acceptability of using standardized educational and communication tools to assist in communication of genetic test results to family members | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of participants that report using the intervention | Evaluate the utility of the communication tool | 1 year | 
| To compare pre- and post test scores to accesses the gaps in traditional genetic counseling education sessions | Evaluate the impact of a patient focused information sheet on the knowledge of genetic testing in women who attend the women's oncology clinic | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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genetic testing, cascade, family disclosure