Hereditary Breast and Ovarian Cancer Syndrome Clinical Trial
Official title:
A Randomized Controlled Trial to Enhance the Use of Genetic Counseling and Testing in Latinas
Verified date | December 2021 |
Source | Georgetown University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators will conduct a two-arm RCT to evaluate the preliminary effectiveness of a culturally-adapted video developed by the team vs. a FORCE fact sheet on enhancing genetic cancer risk assessment (GCRA; including genetic counseling and option for genetic testing) uptake and psychosocial outcomes among Latinas at increased risk for hereditary breast and ovarian cancer (HBOC).
Status | Completed |
Enrollment | 61 |
Est. completion date | January 31, 2022 |
Est. primary completion date | January 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Older than 18 years-old - Self-identify as Latina - Fluent in Spanish - Meet NCCN criteria for breast and/or ovarian genetic cancer risk assessment based on -personal or family history of cancer - Have not received genetic counseling or genetic testing - Able to provide informed consent - No other members of the same family have participated - Must have access to the internet via smartphone, computer, or another device. Exclusion Criteria: - Not fluent in Spanish - Previously received genetic counseling or genetic testing for HBOC - Previously participated in another interventional study about HBOC and GCRA |
Country | Name | City | State |
---|---|---|---|
United States | Nueva Vida | Alexandria | Virginia |
United States | Arlington Free Clinic | Arlington | Virginia |
United States | Virginia Commonwealth University | Richmond | Virginia |
United States | Capital Breast Care Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Georgetown University | Arlington Free Clinic, Basser Center for BRCA, Capital Breast Care Center, Nueva Vida, Inc., Virginia Commonwealth University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Breast cancer genetics knowledge | Change in knowledge about HBOC and GCRA. Knowledge will be measured using a 13-item Erblich et al., 2005 scale about genetic knowledge about breast cancer. The scale has statements to which participants respond True, False, or I don't Know. The scale is scored based on the accuracy of responses. A higher score indicates higher knowledge. Scores range from 0-13. | Change from baseline to two weeks after baseline and change from baseline to three months after baseline | |
Other | Intentions to participate in genetic counseling and genetic testing | Change in intentions to participate in genetic counseling and genetic testing. A 2-item scale developed by Sussner, Jandorf, Thompson, and Valdimarsdottir, 2010 will be used to assess intentions to participate in genetic counseling and testing. Participants respond to a Likert-trype scale from 1 (Not at all) to 5 (Very) how likely it is that they will participate in genetic counseling and testing in the next three months. | Baseline to two weeks after baseline | |
Other | Beliefs and attitudes about genetic counseling and genetic testing | Changes in beliefs and attitudes about genetic counseling and genetic testing. The outcome will be assessed by a 30-item scale developed by Sussner, Jandorf, Thompson et al., 2012 in which participants respond to a Likert-type scale from 1 (completely disagree) to 7 (complete agree). | Baseline to two weeks after baseline | |
Other | Anticipatory Emotions | Changes in anticipatory emotions about receive genetic counseling. Assessed by participants' responses to how they feel 'right now' about the specific behavior of receiving genetic counseling and testing in the next three months. Responses are in a 7-point Likert-type form (from 1-strongly disagree to 7-strongly agree). | Baseline to two weeks after baseline | |
Primary | Genetic counseling uptake | Proportion of participants that receive genetic counseling. The outcome will be assessed by self-report (e.g., Have you received genetic counseling in the past three months?) and confirmed with the genetic counseling company records. | Baseline survey to three months after baseline | |
Secondary | Genetic testing uptake | Proportion of participants that receive genetic testing. The outcome will be assessed by self-report (e.g., Have you received genetic testing in the past three months?) and confirmed with the genetic counseling company records. | Baseline survey to three months after baseline |
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