Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 .
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Feasibility and Acceptability of Genetic Counseling Materials | Other | 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. |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Must have a diagnosis of breast or gynecologic cancers and undergoing any genetic testing at UVA for standard clinical purposes in the Women's Oncology Clinic
Not provided
It is estimated that up to 24% of ovarian cancers are hereditary in nature, with the BRCA genes accounting for 15-18% of cases. Women with BRCA mutations have an up to 65% lifetime risk of breast cancer and an increased risk of uterine serous cancer. With implications for prognosis and treatment, the NCCN and the SGO recently endorsed universal BRCA testing for all women with ovarian cancer. Genetic counseling is recommended for women with triple negative breast cancers, pre-menopausal breast cancer with certain risk factors. Additionally, these results have implications for a patient's family. In a patient with a positive BRCA mutation, first-degree relatives have 50% chance and second-degree relatives have a 25% chance of carrying the mutation.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia | Charlottesville | Virginia | 22902 | United States |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 30, 2017 | Jul 25, 2019 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D020022 | Genetic Predisposition to Disease |
| ID | Term |
|---|---|
| D004198 | Disease Susceptibility |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
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 |