Genetic PredispositionNCT04168736
Family Disclosure in Cascade Testing
An observational study of Genetic Predisposition, run by University of Virginia at 1 site in United States.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Genetic Predisposition
- What is being tested?
- Feasibility and Acceptability of Genetic Counseling Materials
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2017to 30 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age ≥ 18
- Diagnosis of breast or gynecologic cancer
- Undergoing any genetic testing at UVA for standard clinical purposes in the Women's Oncology Clinic
Who cannot join
- Not receiving treatment at UVA
- Not English literate
- Unable to provide consent
- Known pregnancy (self-reported)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22902
About this study
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 .
Read the 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.
- Conditions
- Genetic Predisposition
- Being tested
- Feasibility and Acceptability of Genetic Counseling Materials
- Keywords
- genetic testing, cascade, family disclosure
- Medical subject headings
- Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feasibility and Acceptability of Genetic Counseling MaterialsOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (2)
percentage of participants that report using the intervention
Evaluate the utility of the communication tool
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start30 Jun 2017
- Primary completion30 Jun 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genetic PredispositionStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04168736
- Sponsor's protocol ID
- 19149
- Status last verified
- Nov 2019
- First submitted
- 25 Jul 2019
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Disclosure in Cascade Testing
- ClinicalTrials.gov ID
- NCT04168736
- Acronym / sponsor ID
- 19149
- Conditions
- Genetic Predisposition
- Keywords
- genetic testing, cascade, family disclosure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 30 Jun 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 19 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age ≥ 18
- Diagnosis of breast or gynecologic cancer
- Undergoing any genetic testing at UVA for standard clinical purposes in the Women's Oncology Clinic
Key exclusion criteria (4 listed)
- Not receiving treatment at UVA
- Not English literate
- Unable to provide consent
- Known pregnancy (self-reported)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Feasibility and Acceptability of Genetic Counseling MaterialsTo 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. | Other | – |
Primary outcome
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
2 secondary outcomes
percentage of participants that report using the intervention
Time frame: 1 year
To compare pre- and post test scores to accesses the gaps in traditional genetic counseling education sessions
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Genetic Predisposition, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of family members told in comparison to number of family members (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2019.