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.

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).