Risk Education and Assessment for Cancer Heredity
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Ovarian Cancer, Cancer, Cancer, Other Indications |
| Therapuetic Areas: | Oncology, Other |
| Healthy: | No |
| Age Range: | 25 - 74 |
| Updated: | 4/21/2016 |
| Start Date: | August 2009 |
| End Date: | December 2012 |
Bridging Geographic Barriers: Remote Cancer Genetic Counseling for Rural Women
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 Breast Cancer susceptibility gene
(BRCA) 1/2 mutations.
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 Breast Cancer susceptibility gene
(BRCA) 1/2 mutations.
Following confirmation of eligibility and completion of baseline surveys, participants will
be randomly assigned to one of the study arms by the project coordinator, using a
computer-generated allocation algorithm on the basis of a randomization blocks method using
four, six or eight participants in each block.
In-person and telephone counseling will be delivered by the same board-certified genetic
counselors using a guideline-concordant semi-structured protocol that will allow for
personalization of counseling.
Participants randomly assigned to telephone counseling will be mailed packets that include a
sealed envelope containing an educational brochure about hereditary breast and ovarian
cancer genetic counseling with visual aids. At the time of their session, participants will
review the brochure and genetic counselors will use visual aids to explain breast-ovarian
cancer genetics. Women receiving in-person counseling will be given the same materials
during their session at the community clinic.
For women who elect to have testing, those who have telephone counseling will be sent a
genetic test kit; those who have in-person counseling will have the option of giving a
sample immediately at the clinic, or will be given a test kit with the same instructions as
those in the telephone-counseling group.
When BRCA test results become available, participants will be offered individual post-test
counseling with the same genetic counselor who conducted the pretest session.
be randomly assigned to one of the study arms by the project coordinator, using a
computer-generated allocation algorithm on the basis of a randomization blocks method using
four, six or eight participants in each block.
In-person and telephone counseling will be delivered by the same board-certified genetic
counselors using a guideline-concordant semi-structured protocol that will allow for
personalization of counseling.
Participants randomly assigned to telephone counseling will be mailed packets that include a
sealed envelope containing an educational brochure about hereditary breast and ovarian
cancer genetic counseling with visual aids. At the time of their session, participants will
review the brochure and genetic counselors will use visual aids to explain breast-ovarian
cancer genetics. Women receiving in-person counseling will be given the same materials
during their session at the community clinic.
For women who elect to have testing, those who have telephone counseling will be sent a
genetic test kit; those who have in-person counseling will have the option of giving a
sample immediately at the clinic, or will be given a test kit with the same instructions as
those in the telephone-counseling group.
When BRCA test results become available, participants will be offered individual post-test
counseling with the same genetic counselor who conducted the pretest session.
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
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