Randomized Noninferiority Trial of Telephone vs In-Person Disclosure of Germline Cancer Genetic Test Results

Bradbury, Angela R.; Patrick‐Miller, Linda; Egleston, Brian L.; Hall, Michael J.; Domchek, Susan M.; Daly, Mary B.; Ganschow, Pamela; Grana, Generosa; Olopade, Olufunmilayo I.; Fetzer, Dominique; Brandt, Amanda; Chambers, Rachelle; Clark, Donald W.; Forman, Andrea; Gaber, Rikki; Gulden, Cassandra; Horte, Janice; Long, Jessica M.; Lucas, Terra; Madaan, Shreshtha; Mattie, Kristin; McKenna, Danielle; Montgomery, Susan; Nielsen, Sarah M.; Powers, Jacquelyn; Rainey, Kim; Rybak, Christina; Savage, Michelle; Seelaus, Christina; Stoll, Jessica; Xiao, Yao

doi:10.1093/jnci/djy015

Cited by 37 publications

(110 citation statements)

References 52 publications

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“…These results are consistent with the COGENT study, a multicenter randomized trial of phone compared to in‐person disclosure of germline genetic test results, which included patients undergoing MGPT, the RESPECT study, a study evaluating the uptake and outcomes of returning MGPT research results to research participants, and a recently published study in breast cancer patients focused on cancer worry exclusively . While we found greater increase in uncertainty among patients undergoing MGPT as compared to targeted testing in the COGENT study, longitudinal data from the COGENT study and these data reveal declines in uncertainty over time .…”

Section: Discussionsupporting

confidence: 86%

“…Equally important, and consistent with the COGENT study, we did not identify increased distress in the short‐term or long‐term among the subset with a positive result. Another subgroup of interest are patients who receive a VUS result, given that approximately 30% of patients who undergo MGPT receive a VUS result, which can be difficult for providers and patients to understand .…”

Section: Discussionmentioning

confidence: 78%

“…Knowledge of genetic disease was evaluated (T0‐T4) using an adapted version of the Cancer Genetics Knowledge scale and ClinSeq knowledge scale, evaluating knowledge of inheritance and test interpretation (8 items); and benefits (4 items) and limitations (7 items) of MGPT (Cronbach's α = .78‐.82 across T0‐T4) …”

Section: Methodsmentioning

confidence: 99%

“…There are relatively few studies reporting patient reported cognitive, affective and behavioral outcomes of clinical incorporation of MGPT . In addition, it is not well described how many individuals with prior negative testing for BRCA1/2 are interested in further testing.…”

Section: Introductionmentioning

confidence: 99%

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Longitudinal outcomes with cancer multigene panel testing in previously testedBRCA1/2negative patients

et al. 2020

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Although multigene panel testing (MGPT) is increasingly utilized in clinical practice, there remain limited data on patient‐reported outcomes. BRCA 1/2 negative patients were contacted and offered MGPT. Patients completed pre‐ and posttest counseling, and surveys assessing cognitive, affective and behavioral outcomes at baseline, postdisclosure and 6 and 12 months. Of 317 eligible BRCA1/2 negative patients who discussed the study with research staff, 249 (79%) enrolled. Decliners were more likely to be older, non‐White, and recruited by mail or email. Ninety‐five percent of enrolled patients proceeded with MGPT. There were no significant changes in anxiety, depression, cancer specific distress or uncertainty postdisclosure. There were significant but small increases in knowledge, cancer‐specific distress and depression at 6‐12 months. Uncertainty declined over time. Those with a VUS had significant decreases in uncertainty but also small increases in cancer specific distress at 6 and 12 months. Among those with a positive result, medical management recommendations changed in 26% of cases and 2.6% of all tested. Most BRCA1/2 negative patients have favorable psychosocial outcomes after receipt of MGPT results, although small increases in depression and cancer‐specific worry may exist and may vary by result. Medical management changed in few patients.

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Section: Discussionsupporting

confidence: 86%

Section: Discussionmentioning

confidence: 78%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Longitudinal outcomes with cancer multigene panel testing in previously testedBRCA1/2negative patients

et al. 2020

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“…Uptake of testing was lower in both studies among those who received pretest counseling by telephone. In the more recent Communication Of GENetic Test Results by Telephone (COGENT) study, including a wider range of cancer genetic testing, including multigene panel testing, we also found that telephone disclosure was noninferior to in‐person disclosure of genetic test results for immediate postdisclosure outcomes …”

Section: Introductionmentioning

confidence: 78%

Preferences for in‐person disclosure: Patients declining telephone disclosure characteristics and outcomes in the multicenter Communication Of GENetic Test Results by Telephone study

et al. 2018

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Telephone disclosure of cancer genetic test results is noninferior to in‐person disclosure. However, how patients who prefer in‐person communication of results differ from those who agree to telephone disclosure is unclear but important when considering delivery models for genetic medicine. Patients undergoing cancer genetic testing were recruited to a multicenter, randomized, noninferiority trial (NCT01736345) comparing telephone to in‐person disclosure of genetic test results. We evaluated preferences for in‐person disclosure, factors associated with this preference and outcomes compared to those who agreed to randomization. Among 1178 enrolled patients, 208 (18%) declined randomization, largely given a preference for in‐person disclosure. These patients were more likely to be older (P = 0.007) and to have had multigene panel testing (P < 0.001). General anxiety (P = 0.007), state anxiety (P = 0.008), depression (P = 0.011), cancer‐specific distress (P = 0.021) and uncertainty (P = 0.03) were higher after pretest counseling. After disclosure of results, they also had higher general anxiety (P = 0.003), depression (P = 0.002) and cancer‐specific distress (P = 0.043). While telephone disclosure is a reasonable alternative to in‐person disclosure in most patients, some patients have a strong preference for in‐person communication. Patient age, distress and complexity of testing are important factors to consider and requests for in‐person disclosure should be honored when possible.

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Remotely Delivered Cancer Genetic Testing in the Making Genetic Testing Accessible (MAGENTA) Trial

Swisher,

Rayes,

Bowen

et al. 2023

JAMA Oncol

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ImportanceRequiring personalized genetic counseling may introduce barriers to cancer risk assessment, but it is unknown whether omitting counseling could increase distress.ObjectiveTo assess whether omitting pretest and/or posttest genetic counseling would increase distress during remote testing.Design, Setting, and ParticipantsMaking Genetic Testing Accessible (MAGENTA) was a 4-arm, randomized noninferiority trial testing the effects of individualized pretest and/or posttest genetic counseling on participant distress 3 and 12 months posttest. Participants were recruited via social and traditional media, and enrollment occurred between April 27, 2017, and September 29, 2020. Participants were women aged 30 years or older, English-speaking, US residents, and had access to the internet and a health care professional. Previous cancer genetic testing or counseling was exclusionary. In the family history cohort, participants had a personal or family history of breast or ovarian cancer. In the familial pathogenic variant (PV) cohort, participants reported 1 biological relative with a PV in an actionable cancer susceptibility gene. Data analysis was performed between December 13, 2020, and May 31, 2023.InterventionParticipants completed baseline questionnaires, watched an educational video, and were randomized to 1 of 4 arms: the control arm with pretest and/or posttest genetic counseling, or 1 of 3 study arms without pretest and posttest counseling. Genetic counseling was provided by phone appointments and testing was done using home-delivered saliva kits.Main Outcomes and MeasuresThe primary outcome was participant distress measured by the Impact of Event Scale 3 months after receiving the results. Secondary outcomes included completion of testing, anxiety, depression, and decisional regret.ResultsA total of 3839 women (median age, 44 years [range 22-91 years]), most of whom were non-Hispanic White and college educated, were randomized, 3125 in the family history and 714 in the familial PV cohorts. In the primary analysis in the family history cohort, all experimental arms were noninferior for distress at 3 months. There were no statistically significant differences in anxiety, depression, or decisional regret at 3 months. The highest completion rates were seen in the 2 arms without pretest counseling.Conclusions and RelevanceIn the MAGENTA clinical trial, omitting individualized pretest counseling for all participants and posttest counseling for those without PV during remote genetic testing was not inferior with regard to posttest distress, providing an alternative care model for genetic risk assessment.Trial RegistrationClinicalTrials.gov Identifier: NCT02993068

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Randomized Noninferiority Trial of Telephone vs In-Person Disclosure of Germline Cancer Genetic Test Results

Abstract: Even in the era of multigene panel testing, these data suggest that telephone disclosure of cancer genetic test results is as an alternative to in-person disclosure for interested patients after in-person pretest counseling with a genetic counselor.

Cited by 37 publications

References 52 publications

Longitudinal outcomes with cancer multigene panel testing in previously testedBRCA1/2negative patients

Longitudinal outcomes with cancer multigene panel testing in previously testedBRCA1/2negative patients

Preferences for in‐person disclosure: Patients declining telephone disclosure characteristics and outcomes in the multicenter Communication Of GENetic Test Results by Telephone study

Remotely Delivered Cancer Genetic Testing in the Making Genetic Testing Accessible (MAGENTA) Trial

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