NCT01346761

Risk Education and Assessment for Cancer Heredity

Bridging Geographic Barriers: Remote Cancer Genetic Counseling for Rural Women

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,012 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: Female
• Age: 25 Years – 74 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Breast Cancer
• Ovarian Cancer
• Genetic Predisposition

Interventions

Type	Name	Description
BEHAVIORAL	Telephone Genetic Counseling	Participants will complete a pre-test session and a test results disclosure session (if tested) with a licensed, board-certified genetic counselor over the telephone. Counseling sessions will be audiotaped for quality control of intervention.
BEHAVIORAL	In-Person Genetic Counseling	Participants will complete a pre-test session and a test results disclosure session (if tested) with a licensed, board-certified genetic counselor in person. Counseling sessions will be audiotaped for quality control of intervention.

Timeline

• Start date: 2009-08-01
• Primary completion: 2012-09-01
• Completion: 2012-12-01
• First posted: 2011-05-03
• Last updated: 2016-04-14

Locations

1 site across 1 country: United States