Clinical trial NCT04168736: Family Disclosure in Cascade Testing
Official title: Family Disclosure in Cascade Testing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Genetic Predisposition
Keywords: genetic testing
cascade
family disclosure
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2019-11-19
Enrollment: 50
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: percentage of family members told in comparison to number of family members
timeFrame: 1 year
Secondary outcomes:
measure: percentage of participants that report using the intervention
timeFrame: 1 year
measure: To compare pre- and post test scores to accesses the gaps in traditional genetic counseling education sessions
timeFrame: 1 year
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
References: