Persons living in rural and other geographically underserved areas encounter considerable barriers that reduce or prevent convenient access to quality cancer genetic services. In-person genetic counseling for appropriately selected women by cancer genetic specialists has generally been accepted as the standard of care. The use of telecommunications to deliver clinical genetic services at a site distant from specialists has been suggested as an approach to reduce disparity in access in geographically challenged areas. Remote genetic counseling has the potential to improve health and enhance informed decision-making through access to information and communication with experienced providers without adversely affecting the quality of care. Although telephone counseling has been effectively used as a supplement to in-person genetic services, no published data are available that compare telephone genetic counseling as the sole source of pre-test and post-test disclosure counseling to standard in-person genetic counseling among high-risk women. However, many companies and some providers are offering telephone-based genetic counseling and testing services for cancer susceptibility. Many clinicians and policy makers are concerned about the quality of such counseling and whether counseling conducted over the telephone is as effective as standard in- person counseling. Before widespread adoption and diffusion of telephone-delivered cancer genetic services, it is important to determine whether this mode of genetic communication is comparable to the conventional in-person counseling model within the group where remote counseling is likely to be of greatest benefit, women residing in rural and other underserved areas. This two-group randomized equivalency/non-inferiority trial is designed to determine if genetic counseling delivered by telephone is an acceptable alternative to traditional in-person genetic counseling among 1132 geographically isolated women who have a personal and/or family history of breast and/or ovarian cancer strong enough to suggest that genetic counseling and testing is indicated. We will evaluate the following outcomes: genetic testing uptake, psychological distress, and health-related quality of life. We will also compare the two groups with regard to costs, patient centered communication, and informed decision- making outcomes such as decisional conflict, decision regret and perceived personal control as well as decisions regarding preventive strategies. Overall, our study's findings will provide important information to cancer centers and local public health decision makers about the safety, efficacy, and costs of delivering telephone-based clinical cancer genetic services for rural women at risk for having BRCA 1/2 mutations.

Public Health Relevance

Reducing rural health disparities is a national priority. Our study is innovative in that our approach is unprecedented with regard to provision of remote cancer genetic services to geographically underserved women at increased risk for hereditary breast and ovarian cancer. Many of the outcomes that will be evaluated are important for determining whether telephone- delivered genetic counseling sessions are a reasonable alternative to conventional face-to-face counseling. Outcomes studied include anxiety, cancer worry, quality of life, informed-decision making, costs, as well as utilization of BRCA1/2 gene testing and cancer prevention strategies. Prior to widespread use of telephone-delivered clinical cancer genetic counseling services, it is critical to determine whether efficacy and safety are considerably compromised in a population that is most likely to use these services. Our study's findings may be used to inform clinical practice in rural and other remote areas as well as cancer control policy.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
5R01CA129142-05
Application #
8469399
Study Section
Community-Level Health Promotion Study Section (CLHP)
Program Officer
Mc Donald, Paige A
Project Start
2009-08-13
Project End
2013-07-31
Budget Start
2013-06-01
Budget End
2013-07-31
Support Year
5
Fiscal Year
2013
Total Cost
$37,139
Indirect Cost
$141,697
Name
University of Utah
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
009095365
City
Salt Lake City
State
UT
Country
United States
Zip Code
84112
Kinney, Anita Y; Butler, Karin M; Schwartz, Marc D et al. (2014) Expanding access to BRCA1/2 genetic counseling with telephone delivery: a cluster randomized trial. J Natl Cancer Inst 106: