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OpenTrials
Completed

NCT Number: NCT04168736

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 .

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Key information

Age range

18 year and older

Study type

Observational

Primary location

University of Virginia

Charlottesville, Virginia, 22902, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. percentage of family members told in comparison to number of family members

    Time frame: 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 outcomes

  1. percentage of participants that report using the intervention

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 19, 2019
Registry last updated
Nov 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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