Risk Education and Assessment for Cancer Heredity
Condition: Breast Cancer; Ovarian Cancer; Genetic Predisposition
MeSH terms: Genetic Predisposition to Disease
Study type: Interventional

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.
    

Intervention name(s): Telephone Genetic Counseling; In-Person Genetic Counseling
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Other intervention name(s): BRCA1/BRCA2 genetic counseling via telephone; BRCA1/BRCA2 traditional genetic counseling in-person
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Genetic Counseling; Genetic Counseling Interventions; Genetic Testing; BRCA1 gene; BRCA2 gene; Risk Communication