Expanding access to BRCA1/2 genetic counseling with telephone delivery: a cluster randomized trial.
BACKGROUND
The growing demand for cancer genetic services underscores the need to consider approaches that enhance access and efficiency of genetic counseling. Telephone delivery of cancer genetic services may improve access to these services for individuals experiencing geographic (rural areas) and structural (travel time, transportation, childcare) barriers to access.


METHODS
This cluster-randomized clinical trial used population-based sampling of women at risk for BRCA1/2 mutations to compare telephone and in-person counseling for: 1) equivalency of testing uptake and 2) noninferiority of changes in psychosocial measures. Women 25 to 74 years of age with personal or family histories of breast or ovarian cancer and who were able to travel to one of 14 outreach clinics were invited to participate. Randomization was by family. Assessments were conducted at baseline one week after pretest and post-test counseling and at six months. Of the 988 women randomly assigned, 901 completed a follow-up assessment. Cluster bootstrap methods were used to estimate the 95% confidence interval (CI) for the difference between test uptake proportions, using a 10% equivalency margin. Differences in psychosocial outcomes for determining noninferiority were estimated using linear models together with one-sided 97.5% bootstrap CIs.


RESULTS
Uptake of BRCA1/2 testing was lower following telephone (21.8%) than in-person counseling (31.8%, difference = 10.2%, 95% CI = 3.9% to 16.3%; after imputation of missing data: difference = 9.2%, 95% CI = -0.1% to 24.6%). Telephone counseling fulfilled the criteria for noninferiority to in-person counseling for all measures.


CONCLUSIONS
BRCA1/2 telephone counseling, although leading to lower testing uptake, appears to be safe and as effective as in-person counseling with regard to minimizing adverse psychological reactions, promoting informed decision making, and delivering patient-centered communication for both rural and urban women.
University of New Mexico Cancer Center, Cancer Control, Albuquerque, NM (AYK, K.M. Butler, KGF); Department of Internal Medicine, University of New Mexico, Albuquerque, NM (AYK); Huntsman Cancer Institute, (AYK, K.M. Boucher, LMP, AG, WK, SLE, AMS, SSB, RAC) and Department of Oncological Sciences (K.M. Boucher), University of Utah, Salt Lake City, UT; Department of Internal Medicine, University of Utah School of Medicine, Salt Lake City, UT (AYK, K.M. Boucher, SLE, AMS, SSB); Department of Oncology, Georgetown University Medical Center and Cancer Prevention and Control Program, Georgetown-Lombardi Comprehensive Cancer Center, Washington, DC (MDS, JSM); Department of Epidemiology, Rutgers Cancer Institute of New Jersey Rutgers University, New Brunswick, NJ (AMS). AYKinney@salud.unm.edu.
Anita Y
AY
Kinney
University of New Mexico Cancer Center, Cancer Control, Albuquerque, NM (AYK, K.M. Butler, KGF); Department of Internal Medicine, University of New Mexico, Albuquerque, NM (AYK); Huntsman Cancer Institute, (AYK, K.M. Boucher, LMP, AG, WK, SLE, AMS, SSB, RAC) and Department of Oncological Sciences (K.M. Boucher), University of Utah, Salt Lake City, UT; Department of Internal Medicine, University of Utah School of Medicine, Salt Lake City, UT (AYK, K.M. Boucher, SLE, AMS, SSB); Department of Oncology, Georgetown University Medical Center and Cancer Prevention and Control Program, Georgetown-Lombardi Comprehensive Cancer Center, Washington, DC (MDS, JSM); Department of Epidemiology, Rutgers Cancer Institute of New Jersey Rutgers University, New Brunswick, NJ (AMS).
Karin M
KM
Butler
University of New Mexico Cancer Center, Cancer Control, Albuquerque, NM (AYK, K.M. Butler, KGF); Department of Internal Medicine, University of New Mexico, Albuquerque, NM (AYK); Huntsman Cancer Institute, (AYK, K.M. Boucher, LMP, AG, WK, SLE, AMS, SSB, RAC) and Department of Oncological Sciences (K.M. Boucher), University of Utah, Salt Lake City, UT; Department of Internal Medicine, University of Utah School of Medicine, Salt Lake City, UT (AYK, K.M. Boucher, SLE, AMS, SSB); Department of Oncology, Georgetown University Medical Center and Cancer Prevention and Control Program, Georgetown-Lombardi Comprehensive Cancer Center, Washington, DC (MDS, JSM); Department of Epidemiology, Rutgers Cancer Institute of New Jersey Rutgers University, New Brunswick, NJ (AMS).
Marc D
MD
Schwartz
University of New Mexico Cancer Center, Cancer Control, Albuquerque, NM (AYK, K.M. Butler, KGF); Department of Internal Medicine, University of New Mexico, Albuquerque, NM (AYK); Huntsman Cancer Institute, (AYK, K.M. Boucher, LMP, AG, WK, SLE, AMS, SSB, RAC) and Department of Oncological Sciences (K.M. Boucher), University of Utah, Salt Lake City, UT; Department of Internal Medicine, University of Utah School of Medicine, Salt Lake City, UT (AYK, K.M. Boucher, SLE, AMS, SSB); Department of Oncology, Georgetown University Medical Center and Cancer Prevention and Control Program, Georgetown-Lombardi Comprehensive Cancer Center, Washington, DC (MDS, JSM); Department of Epidemiology, Rutgers Cancer Institute of New Jersey Rutgers University, New Brunswick, NJ (AMS).
Jeanne S
JS
Mandelblatt
University of New Mexico Cancer Center, Cancer Control, Albuquerque, NM (AYK, K.M. Butler, KGF); Department of Internal Medicine, University of New Mexico, Albuquerque, NM (AYK); Huntsman Cancer Institute, (AYK, K.M. Boucher, LMP, AG, WK, SLE, AMS, SSB, RAC) and Department of Oncological Sciences (K.M. Boucher), University of Utah, Salt Lake City, UT; Department of Internal Medicine, University of Utah School of Medicine, Salt Lake City, UT (AYK, K.M. Boucher, SLE, AMS, SSB); Department of Oncology, Georgetown University Medical Center and Cancer Prevention and Control Program, Georgetown-Lombardi Comprehensive Cancer Center, Washington, DC (MDS, JSM); Department of Epidemiology, Rutgers Cancer Institute of New Jersey Rutgers University, New Brunswick, NJ (AMS).
Kenneth M
KM
Boucher
University of New Mexico Cancer Center, Cancer Control, Albuquerque, NM (AYK, K.M. Butler, KGF); Department of Internal Medicine, University of New Mexico, Albuquerque, NM (AYK); Huntsman Cancer Institute, (AYK, K.M. Boucher, LMP, AG, WK, SLE, AMS, SSB, RAC) and Department of Oncological Sciences (K.M. Boucher), University of Utah, Salt Lake City, UT; Department of Internal Medicine, University of Utah School of Medicine, Salt Lake City, UT (AYK, K.M. Boucher, SLE, AMS, SSB); Department of Oncology, Georgetown University Medical Center and Cancer Prevention and Control Program, Georgetown-Lombardi Comprehensive Cancer Center, Washington, DC (MDS, JSM); Department of Epidemiology, Rutgers Cancer Institute of New Jersey Rutgers University, New Brunswick, NJ (AMS).
Lisa M
LM
Pappas
University of New Mexico Cancer Center, Cancer Control, Albuquerque, NM (AYK, K.M. Butler, KGF); Department of Internal Medicine, University of New Mexico, Albuquerque, NM (AYK); Huntsman Cancer Institute, (AYK, K.M. Boucher, LMP, AG, WK, SLE, AMS, SSB, RAC) and Department of Oncological Sciences (K.M. Boucher), University of Utah, Salt Lake City, UT; Department of Internal Medicine, University of Utah School of Medicine, Salt Lake City, UT (AYK, K.M. Boucher, SLE, AMS, SSB); Department of Oncology, Georgetown University Medical Center and Cancer Prevention and Control Program, Georgetown-Lombardi Comprehensive Cancer Center, Washington, DC (MDS, JSM); Department of Epidemiology, Rutgers Cancer Institute of New Jersey Rutgers University, New Brunswick, NJ (AMS).
Amanda
A
Gammon
University of New Mexico Cancer Center, Cancer Control, Albuquerque, NM (AYK, K.M. Butler, KGF); Department of Internal Medicine, University of New Mexico, Albuquerque, NM (AYK); Huntsman Cancer Institute, (AYK, K.M. Boucher, LMP, AG, WK, SLE, AMS, SSB, RAC) and Department of Oncological Sciences (K.M. Boucher), University of Utah, Salt Lake City, UT; Department of Internal Medicine, University of Utah School of Medicine, Salt Lake City, UT (AYK, K.M. Boucher, SLE, AMS, SSB); Department of Oncology, Georgetown University Medical Center and Cancer Prevention and Control Program, Georgetown-Lombardi Comprehensive Cancer Center, Washington, DC (MDS, JSM); Department of Epidemiology, Rutgers Cancer Institute of New Jersey Rutgers University, New Brunswick, NJ (AMS).
Wendy
W
Kohlmann
University of New Mexico Cancer Center, Cancer Control, Albuquerque, NM (AYK, K.M. Butler, KGF); Department of Internal Medicine, University of New Mexico, Albuquerque, NM (AYK); Huntsman Cancer Institute, (AYK, K.M. Boucher, LMP, AG, WK, SLE, AMS, SSB, RAC) and Department of Oncological Sciences (K.M. Boucher), University of Utah, Salt Lake City, UT; Department of Internal Medicine, University of Utah School of Medicine, Salt Lake City, UT (AYK, K.M. Boucher, SLE, AMS, SSB); Department of Oncology, Georgetown University Medical Center and Cancer Prevention and Control Program, Georgetown-Lombardi Comprehensive Cancer Center, Washington, DC (MDS, JSM); Department of Epidemiology, Rutgers Cancer Institute of New Jersey Rutgers University, New Brunswick, NJ (AMS).
Sandra L
SL
Edwards
University of New Mexico Cancer Center, Cancer Control, Albuquerque, NM (AYK, K.M. Butler, KGF); Department of Internal Medicine, University of New Mexico, Albuquerque, NM (AYK); Huntsman Cancer Institute, (AYK, K.M. Boucher, LMP, AG, WK, SLE, AMS, SSB, RAC) and Department of Oncological Sciences (K.M. Boucher), University of Utah, Salt Lake City, UT; Department of Internal Medicine, University of Utah School of Medicine, Salt Lake City, UT (AYK, K.M. Boucher, SLE, AMS, SSB); Department of Oncology, Georgetown University Medical Center and Cancer Prevention and Control Program, Georgetown-Lombardi Comprehensive Cancer Center, Washington, DC (MDS, JSM); Department of Epidemiology, Rutgers Cancer Institute of New Jersey Rutgers University, New Brunswick, NJ (AMS).
Antoinette M
AM
Stroup
University of New Mexico Cancer Center, Cancer Control, Albuquerque, NM (AYK, K.M. Butler, KGF); Department of Internal Medicine, University of New Mexico, Albuquerque, NM (AYK); Huntsman Cancer Institute, (AYK, K.M. Boucher, LMP, AG, WK, SLE, AMS, SSB, RAC) and Department of Oncological Sciences (K.M. Boucher), University of Utah, Salt Lake City, UT; Department of Internal Medicine, University of Utah School of Medicine, Salt Lake City, UT (AYK, K.M. Boucher, SLE, AMS, SSB); Department of Oncology, Georgetown University Medical Center and Cancer Prevention and Control Program, Georgetown-Lombardi Comprehensive Cancer Center, Washington, DC (MDS, JSM); Department of Epidemiology, Rutgers Cancer Institute of New Jersey Rutgers University, New Brunswick, NJ (AMS).
Saundra S
SS
Buys
University of New Mexico Cancer Center, Cancer Control, Albuquerque, NM (AYK, K.M. Butler, KGF); Department of Internal Medicine, University of New Mexico, Albuquerque, NM (AYK); Huntsman Cancer Institute, (AYK, K.M. Boucher, LMP, AG, WK, SLE, AMS, SSB, RAC) and Department of Oncological Sciences (K.M. Boucher), University of Utah, Salt Lake City, UT; Department of Internal Medicine, University of Utah School of Medicine, Salt Lake City, UT (AYK, K.M. Boucher, SLE, AMS, SSB); Department of Oncology, Georgetown University Medical Center and Cancer Prevention and Control Program, Georgetown-Lombardi Comprehensive Cancer Center, Washington, DC (MDS, JSM); Department of Epidemiology, Rutgers Cancer Institute of New Jersey Rutgers University, New Brunswick, NJ (AMS).
Kristina G
KG
Flores
University of New Mexico Cancer Center, Cancer Control, Albuquerque, NM (AYK, K.M. Butler, KGF); Department of Internal Medicine, University of New Mexico, Albuquerque, NM (AYK); Huntsman Cancer Institute, (AYK, K.M. Boucher, LMP, AG, WK, SLE, AMS, SSB, RAC) and Department of Oncological Sciences (K.M. Boucher), University of Utah, Salt Lake City, UT; Department of Internal Medicine, University of Utah School of Medicine, Salt Lake City, UT (AYK, K.M. Boucher, SLE, AMS, SSB); Department of Oncology, Georgetown University Medical Center and Cancer Prevention and Control Program, Georgetown-Lombardi Comprehensive Cancer Center, Washington, DC (MDS, JSM); Department of Epidemiology, Rutgers Cancer Institute of New Jersey Rutgers University, New Brunswick, NJ (AMS).
Rebecca A
RA
Campo
D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000235:genetics / Q000523:psychology; D003657:Decision Making; D005260:Female; D005500:Follow-Up Studies; D019398:Genes, BRCA1; D024522:Genes, BRCA2; D005817:Genetic Counseling / Q000379:methods* / Q000523:psychology*; D005820:Genetic Testing; D006801:Humans; D016014:Linear Models; D008875:Middle Aged; D009154:Mutation; D010051:Ovarian Neoplasms / Q000235:genetics / Q000523:psychology; D011788:Quality of Life; D012042:Registries; D012306:Risk; D012424:Rural Population; D013315:Stress, Psychological / Q000209:etiology / Q000517:prevention & control; D013689:Telephone; D014505:Urban Population; D014589:Utah