Randomized Noninferiority Trial of Telephone Delivery of BRCA1/2 Genetic Counseling Compared With In-Person Counseling: 1-Year Follow-Up.
The ongoing integration of cancer genomic testing into routine clinical care has led to increased demand for cancer genetic services. To meet this demand, there is an urgent need to enhance the accessibility and reach of such services, while ensuring comparable care delivery outcomes. This randomized trial compared 1-year outcomes for telephone genetic counseling with in-person counseling among women at risk of hereditary breast and/or ovarian cancer living in geographically diverse areas.



Using population-based sampling, women at increased risk of hereditary breast and/or ovarian cancer were randomly assigned to in-person (n = 495) or telephone genetic counseling (n = 493). One-sided 97.5% CIs were used to estimate the noninferiority effects of telephone counseling on 1-year psychosocial, decision-making, and quality-of-life outcomes. Differences in test-uptake proportions for determining equivalency of a 10% prespecified margin were evaluated by 95% CIs.



At the 1-year follow-up, telephone counseling was noninferior to in-person counseling for all psychosocial and informed decision-making outcomes: anxiety (difference [d], 0.08; upper bound 97.5% CI, 0.45), cancer-specific distress (d, 0.66; upper bound 97.5% CI, 2.28), perceived personal control (d, -0.01; lower bound 97.5% CI, -0.06), and decisional conflict (d, -0.12; upper bound 97.5% CI, 2.03). Test uptake was lower for telephone counseling (27.9%) than in-person counseling (37.3%), with the difference of 9.4% (95% CI, 2.2% to 16.8%). Uptake was appreciably higher for rural compared with urban dwellers in both counseling arms.



Although telephone counseling led to lower testing uptake, our findings suggest that telephone counseling can be effectively used to increase reach and access without long-term adverse psychosocial consequences. Further work is needed to determine long-term adherence to risk management guidelines and effective strategies to boost utilization of primary and secondary preventive strategies.
Anita Y. Kinney, Laurie E. Steffen, Barbara H. Brumbach, Ruofei Du, Ji-Hyun Lee, Karin Butler, and Kristina G. Flores, University of New Mexico, Albuquerque, NM; Wendy Kohlmann, Amanda Gammon, and Saundra S. Buys, University of Utah, Salt Lake City, UT; Antoinette M. Stroup, Rutgers, The State University of New Jersey, New Brunswick, NJ; Rebecca A. Campo, University of North Carolina at Chapel Hill, Chapel Hill, NC; and Jeanne S. Mandelblatt and Marc D. Schwartz, Georgetown University, Washington, DC. aykinney@salud.unm.edu.
Anita Y
AY
Kinney
Anita Y. Kinney, Laurie E. Steffen, Barbara H. Brumbach, Ruofei Du, Ji-Hyun Lee, Karin Butler, and Kristina G. Flores, University of New Mexico, Albuquerque, NM; Wendy Kohlmann, Amanda Gammon, and Saundra S. Buys, University of Utah, Salt Lake City, UT; Antoinette M. Stroup, Rutgers, The State University of New Jersey, New Brunswick, NJ; Rebecca A. Campo, University of North Carolina at Chapel Hill, Chapel Hill, NC; and Jeanne S. Mandelblatt and Marc D. Schwartz, Georgetown University, Washington, DC.
Laurie E
LE
Steffen
Anita Y. Kinney, Laurie E. Steffen, Barbara H. Brumbach, Ruofei Du, Ji-Hyun Lee, Karin Butler, and Kristina G. Flores, University of New Mexico, Albuquerque, NM; Wendy Kohlmann, Amanda Gammon, and Saundra S. Buys, University of Utah, Salt Lake City, UT; Antoinette M. Stroup, Rutgers, The State University of New Jersey, New Brunswick, NJ; Rebecca A. Campo, University of North Carolina at Chapel Hill, Chapel Hill, NC; and Jeanne S. Mandelblatt and Marc D. Schwartz, Georgetown University, Washington, DC.
Barbara H
BH
Brumbach
Anita Y. Kinney, Laurie E. Steffen, Barbara H. Brumbach, Ruofei Du, Ji-Hyun Lee, Karin Butler, and Kristina G. Flores, University of New Mexico, Albuquerque, NM; Wendy Kohlmann, Amanda Gammon, and Saundra S. Buys, University of Utah, Salt Lake City, UT; Antoinette M. Stroup, Rutgers, The State University of New Jersey, New Brunswick, NJ; Rebecca A. Campo, University of North Carolina at Chapel Hill, Chapel Hill, NC; and Jeanne S. Mandelblatt and Marc D. Schwartz, Georgetown University, Washington, DC.
Wendy
W
Kohlmann
Anita Y. Kinney, Laurie E. Steffen, Barbara H. Brumbach, Ruofei Du, Ji-Hyun Lee, Karin Butler, and Kristina G. Flores, University of New Mexico, Albuquerque, NM; Wendy Kohlmann, Amanda Gammon, and Saundra S. Buys, University of Utah, Salt Lake City, UT; Antoinette M. Stroup, Rutgers, The State University of New Jersey, New Brunswick, NJ; Rebecca A. Campo, University of North Carolina at Chapel Hill, Chapel Hill, NC; and Jeanne S. Mandelblatt and Marc D. Schwartz, Georgetown University, Washington, DC.
Ruofei
R
Du
Anita Y. Kinney, Laurie E. Steffen, Barbara H. Brumbach, Ruofei Du, Ji-Hyun Lee, Karin Butler, and Kristina G. Flores, University of New Mexico, Albuquerque, NM; Wendy Kohlmann, Amanda Gammon, and Saundra S. Buys, University of Utah, Salt Lake City, UT; Antoinette M. Stroup, Rutgers, The State University of New Jersey, New Brunswick, NJ; Rebecca A. Campo, University of North Carolina at Chapel Hill, Chapel Hill, NC; and Jeanne S. Mandelblatt and Marc D. Schwartz, Georgetown University, Washington, DC.
Ji-Hyun
JH
Lee
Anita Y. Kinney, Laurie E. Steffen, Barbara H. Brumbach, Ruofei Du, Ji-Hyun Lee, Karin Butler, and Kristina G. Flores, University of New Mexico, Albuquerque, NM; Wendy Kohlmann, Amanda Gammon, and Saundra S. Buys, University of Utah, Salt Lake City, UT; Antoinette M. Stroup, Rutgers, The State University of New Jersey, New Brunswick, NJ; Rebecca A. Campo, University of North Carolina at Chapel Hill, Chapel Hill, NC; and Jeanne S. Mandelblatt and Marc D. Schwartz, Georgetown University, Washington, DC.
Amanda
A
Gammon
Anita Y. Kinney, Laurie E. Steffen, Barbara H. Brumbach, Ruofei Du, Ji-Hyun Lee, Karin Butler, and Kristina G. Flores, University of New Mexico, Albuquerque, NM; Wendy Kohlmann, Amanda Gammon, and Saundra S. Buys, University of Utah, Salt Lake City, UT; Antoinette M. Stroup, Rutgers, The State University of New Jersey, New Brunswick, NJ; Rebecca A. Campo, University of North Carolina at Chapel Hill, Chapel Hill, NC; and Jeanne S. Mandelblatt and Marc D. Schwartz, Georgetown University, Washington, DC.
Karin
K
Butler
Anita Y. Kinney, Laurie E. Steffen, Barbara H. Brumbach, Ruofei Du, Ji-Hyun Lee, Karin Butler, and Kristina G. Flores, University of New Mexico, Albuquerque, NM; Wendy Kohlmann, Amanda Gammon, and Saundra S. Buys, University of Utah, Salt Lake City, UT; Antoinette M. Stroup, Rutgers, The State University of New Jersey, New Brunswick, NJ; Rebecca A. Campo, University of North Carolina at Chapel Hill, Chapel Hill, NC; and Jeanne S. Mandelblatt and Marc D. Schwartz, Georgetown University, Washington, DC.
Saundra S
SS
Buys
Anita Y. Kinney, Laurie E. Steffen, Barbara H. Brumbach, Ruofei Du, Ji-Hyun Lee, Karin Butler, and Kristina G. Flores, University of New Mexico, Albuquerque, NM; Wendy Kohlmann, Amanda Gammon, and Saundra S. Buys, University of Utah, Salt Lake City, UT; Antoinette M. Stroup, Rutgers, The State University of New Jersey, New Brunswick, NJ; Rebecca A. Campo, University of North Carolina at Chapel Hill, Chapel Hill, NC; and Jeanne S. Mandelblatt and Marc D. Schwartz, Georgetown University, Washington, DC.
Antoinette M
AM
Stroup
Anita Y. Kinney, Laurie E. Steffen, Barbara H. Brumbach, Ruofei Du, Ji-Hyun Lee, Karin Butler, and Kristina G. Flores, University of New Mexico, Albuquerque, NM; Wendy Kohlmann, Amanda Gammon, and Saundra S. Buys, University of Utah, Salt Lake City, UT; Antoinette M. Stroup, Rutgers, The State University of New Jersey, New Brunswick, NJ; Rebecca A. Campo, University of North Carolina at Chapel Hill, Chapel Hill, NC; and Jeanne S. Mandelblatt and Marc D. Schwartz, Georgetown University, Washington, DC.
Rebecca A
RA
Campo
Anita Y. Kinney, Laurie E. Steffen, Barbara H. Brumbach, Ruofei Du, Ji-Hyun Lee, Karin Butler, and Kristina G. Flores, University of New Mexico, Albuquerque, NM; Wendy Kohlmann, Amanda Gammon, and Saundra S. Buys, University of Utah, Salt Lake City, UT; Antoinette M. Stroup, Rutgers, The State University of New Jersey, New Brunswick, NJ; Rebecca A. Campo, University of North Carolina at Chapel Hill, Chapel Hill, NC; and Jeanne S. Mandelblatt and Marc D. Schwartz, Georgetown University, Washington, DC.
Kristina G
KG
Flores
Anita Y. Kinney, Laurie E. Steffen, Barbara H. Brumbach, Ruofei Du, Ji-Hyun Lee, Karin Butler, and Kristina G. Flores, University of New Mexico, Albuquerque, NM; Wendy Kohlmann, Amanda Gammon, and Saundra S. Buys, University of Utah, Salt Lake City, UT; Antoinette M. Stroup, Rutgers, The State University of New Jersey, New Brunswick, NJ; Rebecca A. Campo, University of North Carolina at Chapel Hill, Chapel Hill, NC; and Jeanne S. Mandelblatt and Marc D. Schwartz, Georgetown University, Washington, DC.
Jeanne S
JS
Mandelblatt
Anita Y. Kinney, Laurie E. Steffen, Barbara H. Brumbach, Ruofei Du, Ji-Hyun Lee, Karin Butler, and Kristina G. Flores, University of New Mexico, Albuquerque, NM; Wendy Kohlmann, Amanda Gammon, and Saundra S. Buys, University of Utah, Salt Lake City, UT; Antoinette M. Stroup, Rutgers, The State University of New Jersey, New Brunswick, NJ; Rebecca A. Campo, University of North Carolina at Chapel Hill, Chapel Hill, NC; and Jeanne S. Mandelblatt and Marc D. Schwartz, Georgetown University, Washington, DC.
Marc D
MD
Schwartz
D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000235:genetics; D005260:Female; D005500:Follow-Up Studies; D019398:Genes, BRCA1; D024522:Genes, BRCA2; D005817:Genetic Counseling / Q000379:methods*; D006801:Humans; D008875:Middle Aged; D009154:Mutation; D010051:Ovarian Neoplasms / Q000235:genetics; D013689:Telephone