Family Disclosure in Cascade Testing

• Sponsor: University of Virginia (Other)
• Overall Status: Completed
• CT.gov ID: NCT04168736
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Actual Duration (Months): 18
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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 .

Condition or Disease	Intervention/Treatment	Phase
Genetic Predisposition	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 Design

• Study Type: Observational
• Actual Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Family Disclosure in Cascade Testing
• Actual Study Start Date: Jun 30, 2017
• Actual Primary Completion Date: Jun 30, 2018
• Actual Study Completion Date: Dec 30, 2018

Outcome Measures

Primary Outcome Measures

1. 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

1. percentage of participants that report using the intervention [1 year]

   Evaluate the utility of the communication tool

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Virginia	Charlottesville	Virginia	United States	22902

Sponsors and Collaborators

• University of Virginia

Investigators

None specified.

Study Documents (Full-Text)

• Informed Consent Form - Jun 30, 2017

More Information

Publications

None provided.

• Responsible Party: University of Virginia
• ClinicalTrials.gov Identifier: NCT04168736
• Other Study ID Numbers: 19149
• First Posted: Nov 19, 2019
• Last Update Posted: Nov 19, 2019
• Last Verified: Nov 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Virginia: genetic testing; cascade; family disclosure
• Additional relevant MeSH terms: Disease Susceptibility; Genetic Predisposition to Disease

Study Results

No Results Posted as of Nov 19, 2019