Family Disclosure in Cascade Testing

NCT04168736 | Completed DMC

• 1 other identifier: 19149
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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 .

Conditions

Genetic Predisposition

Keywords

genetic testing; cascade; family disclosure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• percentage of participants that report using the intervention

  1 year

• To compare pre- and post test scores to accesses the gaps in traditional genetic counseling education sessions

  1 year

Interventions

Feasibility and Acceptability of Genetic Counseling Materials OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Must have a diagnosis of breast or gynecologic cancers and undergoing any genetic testing at UVA for standard clinical purposes in the Women's Oncology Clinic
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age ≥ 18
• Diagnosis of breast or gynecologic cancer
• Undergoing any genetic testing at UVA for standard clinical purposes in the Women's Oncology Clinic

You may not qualify if:

• Not receiving treatment at UVA
• Not English literate
• Unable to provide consent
• Known pregnancy (self-reported)

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22902, United States

Location

MeSH Terms

Conditions

Genetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: November 19, 2019
• Study Start: June 30, 2017
• Primary Completion: June 30, 2018
• Study Completion: December 30, 2018
• Last Updated: November 19, 2019

Record last verified: 2019-11

Locations

US (1)