Hereditary Breast and Ovarian Cancer Syndrome Clinical Trial
Official title:
Statewide Communication to Reach Diverse Low Income Women
Verified date | September 2021 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Recruitment for prevention, and early detection among health disparities populations represents a major challenge in chronic disease control. This effect is magnified for individuals at high risk for conditions such as genetic breast cancer or chronic hepatitis. Costs are typically high, particularly given the common practice of developing a single outreach channel to address each disease or condition. In a randomized delayed intervention control trial, the investigators tested a strategy to identify low-income women at high risk for hereditary breast and ovarian cancer (HBOC) outside the clinical setting and refer them to free genetic counseling.
Status | Completed |
Enrollment | 88 |
Est. completion date | June 2013 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 25 Years and older |
Eligibility | Inclusion Criteria - Residence within one of six local counties (for ease of access to our sites offering free genetic counseling and testing), age 25+, and English- or Spanish-speaking (the languages in which genetic counseling was conducted at risk program sites). Exclusion Criteria - American Indian/Alaska Native and Native Hawaiian/Other Pacific Islander will not be included since very few call EWC. - Children (individuals under 25 years of age) will not be included in the study. - The rationale for this exclusion is that the research topic is not relevant to children. - The EWC does not target children, whose medical care is typically under the control of their parents or guardians. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | Cancer Prevention Institute of California, National Cancer Institute (NCI) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Receipt of Genetic Counseling During Intervention Period | The primary outcome measure is receipt of genetic counseling within the two month intervention period. | Up to three years | |
Secondary | Time to Counseling | The study arms were compared with respect to time from randomization to counseling appointment using the log-rank test, and Kaplan-Meier curves were computed for each study arm. | Up to three years |
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