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Randomized Controlled Trial
. 2016 Aug 20;34(24):2914-24.
doi: 10.1200/JCO.2015.65.9557. Epub 2016 Jun 20.

Randomized Noninferiority Trial of Telephone Delivery of BRCA1/2 Genetic Counseling Compared With In-Person Counseling: 1-Year Follow-Up

Anita Y Kinney  1 , Laurie E Steffen  2 , Barbara H Brumbach  2 , Wendy Kohlmann  2 , Ruofei Du  2 , Ji-Hyun Lee  2 , Amanda Gammon  2 , Karin Butler  2 , Saundra S Buys  2 , Antoinette M Stroup  2 , Rebecca A Campo  2 , Kristina G Flores  2 , Jeanne S Mandelblatt  2 , Marc D Schwartz  2
Affiliations
Randomized Controlled Trial

Randomized Noninferiority Trial of Telephone Delivery of BRCA1/2 Genetic Counseling Compared With In-Person Counseling: 1-Year Follow-Up

Anita Y Kinney et al. J Clin Oncol. .

Abstract

Purpose: 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.

Patients and methods: 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.

Results: 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.

Conclusion: 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.

Trial registration: ClinicalTrials.gov NCT01346761.

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Conflict of interest statement

Authors’ disclosures of potential conflicts of interest are found in the article online at www.jco.org. Author contributions are found at the end of this article.

Figures

Fig 1.
Fig 1.
CONSORT diagram. *Seven families had at least one member randomly assigned and one member not randomly assgned. †Total number of participants depends on completion of intervention and completion of measure. ‡Intent-to-treat refers to data analysis after imputation of unknown testing uptake. GC, genetic counseling; HBOC, hereditary breast and ovarian cancer.
Fig 2.
Fig 2.
Effects and noninferiority ranges 1 year after the last intervention. GC, genetic counseling; IP, in person; TEL, telephone.
See this image and copyright information in PMC

Comment in

References

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