Family Disclosure in Cascade Testing

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 .

Study Overview

• Status: Completed
• Conditions: Genetic Predisposition
• Intervention / Treatment: Other: Feasibility and Acceptability of Genetic Counseling Materials

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 Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22902
      • University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Virginia

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2017
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): December 30, 2018

Study Registration Dates

• First Submitted: July 25, 2019
• First Submitted That Met QC Criteria: November 17, 2019
• First Posted (Actual): November 19, 2019

Study Record Updates

• Last Update Posted (Actual): November 19, 2019
• Last Update Submitted That Met QC Criteria: November 17, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: genetic testing; cascade; family disclosure
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease Susceptibility; Genetic Predisposition to Disease
• Other Study ID Numbers: 19149

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No