NCT04168736

Family Disclosure in Cascade Testing

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: —
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Genetic Predisposition

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-06-30
• Primary completion: 2018-06-30
• Completion: 2018-12-30
• First posted: 2019-11-19
• Last updated: 2019-11-19

Locations

1 site across 1 country: United States