Family Disclosure in Cascade Testing

Completed

• Conditions: Genetic Predisposition

• Registration Number: NCT04168736
• Lead Sponsor: University of Virginia

Brief 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.

Study Timeline

• Study Start: 2017-06-30
• Primary Completion: 2018-06-30
• Study Completion: 2018-12-30
• Study First Submitted: 2019-07-25
• Status Verified: 2019-11
• Study First Submitted QC: 2019-11-17
• Last Update Submitted: 2019-11-17
• Study First Posted: 2019-11-19
• Last Update Posted: 2019-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 50

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
percentage of family members told in comparison to number of family members	1 year	Evaluate the feasibility and acceptability of using standardized educational and communication tools to assist in communication of genetic test results to family members

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States