Family Disclosure in Cascade Testing

Genetic Predisposition Clinical Trial

Official title:

Family Disclosure in Cascade Testing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04168736
• Other study ID #: 19149
• Status: Completed
• Start date: June 30, 2017
• Est. completion date: December 30, 2018

Study information

• Verified date: November 2019
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Disease Susceptibility
• Genetic Predisposition
• Genetic Predisposition to Disease

Intervention

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.

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	percentage of participants that report using the intervention	Evaluate the utility of the communication tool	1 year
Secondary	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