Risk Education and Assessment for Cancer Heredity
This trial is active, not recruiting.
|Conditions||breast cancer, ovarian cancer, genetic predisposition|
|Treatment||brca1/brca2 genetic counseling|
|Sponsor||University of Utah|
|Collaborator||National Cancer Institute (NCI)|
|Start date||August 2009|
|End date||May 2016|
|Trial size||1021 participants|
|Trial identifier||NCT01346761, 1R01CA129142-01A2, 23146|
Individuals living in geographically underserved areas encounter considerable barriers to access of quality cancer genetic services. Although in-person genetic counseling has generally been accepted as the standard of care, the use of telecommunications to deliver clinical genetic services may help reduce this disparity in access to such services. However, before the widespread adoption of telephone-delivered cancer genetic services occurs, it is critical to analyze the efficacy and safety of this mode of communication. This two-group randomized equivalency/non-inferiority trial will determine whether telephone-based cancer genetic counseling is an acceptable alternative to the traditional in-person mode among women who have a personal or family history of breast and/or ovarian cancer strong enough to warrant genetic counseling and testing. This study's findings will provide important information to cancer centers and cancer control policies about the safety, efficacy, and costs of delivering telephone-based clinical cancer genetic services for geographically challenged women at risk for having BRCA 1/2 mutations.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (outcomes assessor)|
|Primary purpose||health services research|
Determine the non-inferiority/equivalency of telephone genetic counseling to standard in-person genetic counseling
time frame: 12-month follow-up
Determine the feasibility of the intervention
time frame: 1 week pre-test, 1 week post-test, 6 & 12 month follow-ups
Female participants from 25 years up to 74 years old.
Inclusion Criteria: - Utah resident - Meets National Comprehensive Cancer Network (NCCN) guidelines for hereditary breast/ovarian cancer syndrome (personal and/or family history of breast and/or ovarian cancer, or is a member of a family with a known positive BRCA1/BRCA2 mutation). Exclusion Criteria: - Has had genetic counseling and/or BRCA 1/2 testing - Physically or mentally unable to complete telephone surveys, telephone or in-person counseling or provide informed consent. - Unable to read and speak English fluently - Unable to travel to in-person genetic counseling session (17 in-person sites throughout Utah) - Male gender
|Official title||Bridging Geographic Barriers: Remote Cancer Genetic Counseling for Rural Women|
|Principal investigator||Anita Y. Kinney, R.N., Ph.D.|
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