Randomized study of remote telehealth genetic services versus usual care in oncology practices without genetic counselors

Abstract

Purpose: To examine the benefit of telehealth over current delivery options in oncology practices without genetic counselors.

Methods: Participants meeting cancer genetic testing guidelines were recruited to this multi-center, randomized trial comparing uptake of genetic services with remote services (telephone or videoconference) to usual care in six predominantly community practices without genetic counselors. The primary outcome was the composite uptake of genetic counseling or testing. Secondary outcomes compare telephone versus videoconference services.

Results: 147 participants enrolled and 119 were randomized. Eighty percent of participants in the telehealth arm had genetic services as compared to 16% in the usual care arm (OR 30.52, p < 0.001). Five genetic mutation carriers (6.7%) were identified in the telehealth arm, compared to none in the usual care arm. In secondary analyses, factors associated with uptake were lower anxiety (6.77 vs. 8.07, p = 0.04) and lower depression (3.38 vs. 5.06, p = 0.04) among those who had genetic services. There were no significant differences in change in cognitive or affective outcomes immediately post-counseling and at 6 and 12 months between telephone and videoconference arms.

Conclusion: Telehealth increases uptake of genetic counseling and testing at oncology practices without genetic counselors and could significantly improve identification of genetic carriers and cancer prevention outcomes.

Keywords: alternative service delivery; cancer genetics; cancer predisposition syndromes; genetic counseling; genetic testing; genetics; telegenetics; telehealth; telemedicine.

FIGURE 1

Study consort. *One enrolled participant was found to be ineligible and not randomized. ⁺One participant completed T0 survey but we were unable to reach the participant to complete randomization. ⁺⁺Randomization was initially 1:1:1 (remote phone: remote videoconference: usual care), but was changed to 1:1:2 to achieve adequate enrollment to meet our primary outcomes. ^One participant deceased. **Includes five participants who had external testing but not through our remote services (e.g. not per protocol). ***Does not include five participants who had external testing, because we can't confirm outside pre‐test counseling. ^a Includes five participants who had external testing and 45 remote participants who had V1 and blood draw within 6 months of randomization. ^bTesting deferred includes: (1) two participants who waited for relatives to test first and did not get genetic testing; one participant waited for mother's genetic testing but did finally have genetic testing through remote services. ^cOne participant died before results could be disclosed; two participants had disclosures at 7 and 8.8 months post randomization, respectively. ^dOne UC participant received results at 7.3 months