Randomized noninferiority trial of telephone versus in-person genetic counseling for hereditary breast and ovarian cancer

Abstract

Purpose: Although guidelines recommend in-person counseling before BRCA1/BRCA2 gene testing, genetic counseling is increasingly offered by telephone. As genomic testing becomes more common, evaluating alternative delivery approaches becomes increasingly salient. We tested whether telephone delivery of BRCA1/2 genetic counseling was noninferior to in-person delivery.

Patients and methods: Participants (women age 21 to 85 years who did not have newly diagnosed or metastatic cancer and lived within a study site catchment area) were randomly assigned to usual care (UC; n = 334) or telephone counseling (TC; n = 335). UC participants received in-person pre- and post-test counseling; TC participants completed all counseling by telephone. Primary outcomes were knowledge, satisfaction, decision conflict, distress, and quality of life; secondary outcomes were equivalence of BRCA1/2 test uptake and costs of delivering TC versus UC.

Results: TC was noninferior to UC on all primary outcomes. At 2 weeks after pretest counseling, knowledge (d = 0.03; lower bound of 97.5% CI, -0.61), perceived stress (d = -0.12; upper bound of 97.5% CI, 0.21), and satisfaction (d = -0.16; lower bound of 97.5% CI, -0.70) had group differences and confidence intervals that did not cross their 1-point noninferiority limits. Decision conflict (d = 1.1; upper bound of 97.5% CI, 3.3) and cancer distress (d = -1.6; upper bound of 97.5% CI, 0.27) did not cross their 4-point noninferiority limit. Results were comparable at 3 months. TC was not equivalent to UC on BRCA1/2 test uptake (UC, 90.1%; TC, 84.2%). TC yielded cost savings of $114 per patient.

Conclusion: Genetic counseling can be effectively and efficiently delivered via telephone to increase access and decrease costs.

Trial registration: ClinicalTrials.gov NCT00287898.

Conflict of interest statement

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Figures

Fig 1.

Study flow chart. TC, telephone genetic counseling; UC, usual care (standard in-person genetic counseling).

Fig 2.

Noninferiority analyses comparing telephone to standard delivery of genetic counseling at predisclosure (2 weeks). TC, telephone genetic counseling; UC, usual care (standard in-person genetic counseling).

Fig 3.

Noninferiority analysis comparing telephone to standard delivery of genetic counseling at postdisclosure (3 months). TC, telephone genetic counseling; UC, usual care (standard in-person genetic counseling).