Key Points
Question
What amount of personalized genetic counseling impacts distress in remote cancer genetic testing?
Findings
In this 4-armed randomized clinical trial of 3839 women, not mandating pretest genetic counseling for all and posttest counseling for those without pathogenic variants was noninferior to mandating individualized pretest and posttest counseling on participant distress during remote delivery of genetic testing for cancer risk. There were no significant differences in anxiety, depression, or decisional regret at 3 months.
Meaning
The results of this trial suggest that, for women without findings of pathogenic variants, not mandating genetic counseling for cancer risk testing did not increase posttest distress, providing an alternative model for care delivery for a low-risk population.
Abstract
Importance
Requiring personalized genetic counseling may introduce barriers to cancer risk assessment, but it is unknown whether omitting counseling could increase distress.
Objective
To assess whether omitting pretest and/or posttest genetic counseling would increase distress during remote testing.
Design, Setting, and Participants
Making 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.
Intervention
Participants 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 Measures
The 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.
Results
A 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 Relevance
In 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 Registration
ClinicalTrials.gov Identifier: NCT02993068
This randomized clinical trial evaluates whether eliminating pretest and/or posttest counseling for home-delivered cancer risk assessment is noninferior with regard to participant distress.
Introduction
Identifying genetic risk of cancer provides an important opportunity for cancer prevention and surveillance.1 Recommendations from the US Preventive Service Task Force were made in 2005 to screen individuals for personal and family history suggestive of hereditary breast and ovarian cancer and offer at-risk individuals genetic counseling and testing.2 Nevertheless, a later study suggested that less than 10% of patients without cancer with a suggestive family history of hereditary breast and ovarian cancer have received testing, and that rate did not change during a 10-year observation period.3
Low population awareness contributes to poor use of genetic testing for cancer risk.4 Other barriers cluster around the multiple steps required to access genetic testing and services.5,6,7 The traditional clinical paradigm for genetic testing has required an in-person visit with a trained professional for pretest counseling and a second to receive results with posttest counseling. There is uneven use of genetic testing based on geographic location, race and ethnicity, income, and insurance status.8,9,10 The question of whether all patients need pretest and/or posttest individualized genetic counseling is critical, as a shortage of genetic counselors has been identified as a major barrier to testing, with rural areas and certain regions harder hit.6,7
Several investigators have reported the acceptability and equivalency of telephone-delivered genetic counseling compared with in person, providing an alternative counseling delivery option.11,12,13,14,15 In the Making Genetic Testing Accessible (MAGENTA) trial, we wanted to assess whether not mandating individualized genetic counseling causes psychological harm. Therefore, we designed MAGENTA as a 4-armed noninferiority trial that tested whether eliminating pretest and/or posttest counseling for home-delivered cancer risk assessment is noninferior with regard to participant distress at 3 months after receipt of results in comparison with standard mandatory pretest and posttest counseling.
Methods
Design
The protocol was approved by the MD Anderson Cancer Center Institutional Review Board and is provided in Supplement 1.16 Participants provided informed consent; no financial compensation was provided. Briefly, MAGENTA is a 4-armed, randomized, noninferiority trial assessing the effect of eliminating mandatory pretest (for all individuals) and posttest genetic counseling (for those without PVs) on distress caused by cancer-specific worry. Arm A had no mandatory pretest or posttest counseling; arm B mandated posttest counseling only; arm C was the control arm and required pretest and posttest telephone counseling; and arm D mandated pretest counseling only. In all arms, posttest counseling was required for participants with PVs, and participants in any arm could opt for telephone counseling at any point. The primary outcome was distress at 3 months posttest in the family history cohort. A secondary enrollment group included participants with a family history of a PV in a cancer risk gene (familial PV cohort). Recruitment was conducted using social media and other electronic contacts.17 Briefly, participants completed an eligibility survey via REDCap.18 If eligible, they provided informed consent remotely, completed a baseline survey, were randomized equally to each study arm stratified by risk group using the REDCap randomization feature and then completed testing through Color Health. Race and ethnicity were self-identified and used to understand the diversity and representation of the study population. This study followed the Consolidated Standards of Reporting Trials (CONSORT) reporting guideline.
Hypothesis Testing and Power Analysis
The study was designed to test the primary hypothesis in the family history cohort. Each of the 3 experimental study arms was to be compared with the control study arm using a 1-sided t test, with the null hypothesis for each comparison being that the mean distress score in the experimental arm is more than 4 points above that in the control arm. The noninferiority margin of 4 points was suggested by Schwartz et al.19 A 1-sided significance level of P = .025 was targeted across all 3 tests, resulting in a Bonferroni-corrected significance level of P = .0083 for each test. The sample size was chosen to achieve 93% power for each test in the family history cohort, assuming an SD in the scores of 15.3 based on Schwartz et al,19 yielding an overall power of 80%. Additional statistical considerations are provided in the eMethods in Supplement 2. Statistical analysis was conducted with R, version 4.2.2 (R Foundation for Statistical Computing).
Eligibility
Participants were women aged 30 years or older, English speaking, lived in the US, and had access to a health care professional. Previous genetic testing or counseling for cancer risk was exclusionary. Detailed eligibility criteria are provided in eTable 1 in Supplement 2.16 In the familial PV cohort, participants needed 1 biological relative with a PV in BRCA1, BRCA2, BRIP1, PALB2, RAD51C, RAD51D, BARD1, MSH2, MSH6, MLH1, or PMS2.
Intervention
After randomization, all participants watched a pretest educational video about cancer genetic testing20 and proceeded through the steps outlined in Figure 1. Randomization and data storage were managed through REDCap.18
Figure 1. Study Flow and Participant Progression Through Each Trial Stage.
Arm A had no mandatory pretest or posttest counseling, arm B mandated posttest counseling only, arm C was the control group, and arm D mandated pretest counseling only.
Outcomes
The primary outcome was cancer risk distress measured by the Impact of Event Scale (IES) at 3 months posttest in the family history cohort. The score range of IES is 0 to 75, with high distress defined as 20 or greater.21,22 Secondary/exploratory outcomes and their measures included completion of testing; anxiety (Generalized Anxiety Disorder, 7-item [GAD-7])23; depression (Patient Health Questionnaire, 9 [PHQ-9])24; quality of life (Veterans RAND 12-item Health Survey)25; and the Decisional Regret Scale.26 The GAD-7 score ranges from 0 to 21 (0-4: minimal anxiety, 5-9: mild anxiety. 10-14: moderate anxiety, and >15: severe anxiety). The PHQ-9 score ranges from 0 to 27 (0-4: none or minimal depression, 5-9: mild depression, 10-14: moderate depression, 15-19: moderately severe depression, and ≥20: severe depression). The Veterans Rand 12-item Health Survey reports 2 summary scores: a mental component score and a physical component score. The scores may be reported as z scores (difference compared with the population average, measured in SDs). The US population average mental component score and physical component score are both 50 points. The Decisional Regret Scale ranges from 0 to 100 (0: no regret; 100: high regret).
Statistical Analysis
Data analysis was performed between December 13, 2020, and May 31, 2023. The primary analysis was a comparison of distress scores between arms in the family history cohort. Following the prespecified analysis plan for the primary hypothesis, 99.17% 1-sided CIs were constructed for the differences in distress scores between study arms A, B, and D compared with control arm C. If the upper bound of the CI was less than the noninferiority margin of 4, this was considered grounds to reject the null hypothesis. This is equivalent to three 1-sided t tests at the P < .0082 level. A similar noninferiority analysis was performed for the prespecified secondary completion rate. Other comparisons were exploratory and were performed for superiority/difference. Additional statistical considerations and analyses are available in the eMethods in Supplement 1.
Results
Figure 1 shows the diagram for participants screened to completion of posttest questionnaires. Participant demographic characteristics are provided in Table 1, with breakdown by study arm in eTable 2 in Supplement 1. In the family history (n = 3125) and familial PV (n = 714) cohorts, individuals were randomized between April 27, 2017, and September 29, 2020. Participants were relatively evenly distributed geographically with representation from all 50 states, with the exception Minnesota, where advocacy was highly effective, resulting in 1321 of 3839 (34.4%) randomized individuals enrolling from Minnesota (eFigure 1 in Supplement 2). The frequency of requests for additional counseling, which was allowed in all arms, was not formally recorded, but counselors reported that participants rarely (<5%) reached out for additional counseling.
Table 1. Demographic Characteristics of Participants.
| Characteristic | No. (%) | ||
|---|---|---|---|
| Family history | Familial PV | Overall | |
| Total randomized | 3125 (81.4) | 714 (18.6) | 3839 |
| Age, median (range), ya | 45 (22-91) | 42 (28-83) | 44 (22-91) |
| Personal history of breast cancer | 125 (4.2) | NA | NA |
| Race and ethnicityb | |||
| Asian/Pacific Islander/Native Hawaiian | 46 (1.5) | 7 (1.0) | 53 (1.4) |
| Black | 76 (2.4) | 27 (3.8) | 103 (2.7) |
| Hispanic | 95 (3.0) | 43 (6.0) | 138 (3.6) |
| Native American/Alaskan Native | 31 (1.0) | 12 (1.7) | 43 (1.1) |
| White | 2985 (95.6) | 672 (94.1) | 3657 (95.3) |
| Educational level | |||
| ≤ Grade 12 | 282 (9.0) | 111 (15.5) | 393 (10.2) |
| Any college | 1942 (62.1) | 474 (66.4) | 2416 (62.9) |
| Post college | 877 (28.1) | 120 (16.8) | 997 (26.0) |
Abbreviations: NA, not available; PV, pathogenic variant.
Eligibility required age of 30 years or older, but a few participants passed eligibility screening then supplied a date of birth on baseline questionnaire that placed their age younger.
Total is greater than the number randomized as participants could indicate more than 1 race and ethnicity.
Among participants who completed the genetic testing, 156 individuals (4.1%) had 158 germline PVs in a breast or ovarian cancer gene, which was 5.5% of the 2839 kits that were returned and sequenced (Table 2). For the family history cohort, there were 99 PVs identified in 97 participants (3.1% of randomized and 3.2% of sequenced participants). For the familial PV cohort, there were 59 PVs identified in 59 participants (8.3% of randomized and 9.4% of sequenced participants). Twenty-six participants had missense variants in CHEK2, including 22 with the common p.Ile157Thr variant that confers a very modest increase in breast cancer risk.27 Because missense variants in CHEK2 are not considered clinically actionable, these variants were not counted among the PVs, but these participants did receive mandatory posttest counseling.
Table 2. Germline PVs Identified in the 2 Study Cohorts.
| Germline PV | No. (%) | ||
|---|---|---|---|
| Family history (n = 2341) | Familial PV (n = 498)a | Total (N = 2839) | |
| Variants (No. of participants) | 99 (97) | 59 (59) | 158 (156) |
| ATM | 19 (0.81) | 4 (0.8) | 23 (0.81) |
| BARD1 | 1 (0.04) | 0 | 1 (0.04) |
| BRCA1 | 10 (0.43) | 12 (2.41) | 22 (0.77) |
| BRCA2 | 13 (0.56) | 15 (3.01) | 28 (0.99) |
| BRIP1 | 14 (0.6) | 5 (0.7) | 19 (0.67) |
| CHEK2 b | 16 (0.68) | 8 (1.61) | 24 (0.85) |
| MLH1 | 1 (0.04) | 1 (0.2) | 2 (0.07) |
| MSH2 | 0 | 1 (0.2) | 1 (0.04) |
| NBN | 10 (0.43) | 2 (0.4) | 12 (0.42) |
| PALB2 | 5 (0.21) | 2 (0.4) | 7 (0.25) |
| PMS2 | 3 (0.13) | 4 (0.8) | 7 (0.25) |
| RAD51C | 4 (0.17) | 2 (0.4) | 6 (0.21) |
| RAD51D | 3 (0.13) | 2 (0.4) | 5 (0.18) |
| STK11 | 0 | 1 (0.2) | 1 (0.04) |
Abbreviation: PV, pathogenic variant.
Pathogenic variants were equally distributed among the 4 arms for each cohort.
Twenty-six CHEK2 missense variants in the family history cohort and 3 in the familial PV cohort were not counted in the total CHEK2 PV count.
In the primary analysis in the family history cohort, each of the 3 experimental arms was noninferior to the control arm for distress at 3 months. Distress at 3 months was not significantly different across the arms (Figure 2A). Difference in distress from baseline to 3 months was also not significantly different across arms. In the familial PV cohort, no test and pretest-only counseling were also found to be noninferior for distress at 3 months. Overall, 366 participants (19%) had very high distress at 3 months, and this rate was not significantly different across arms (eFigure 2 in Supplement 2).
Figure 2. Outcome Measures at 3 Months.
A, Distress measured by the impact of events score across the 4 arms. B, anxiety as measured by the Generalized Anxiety Disorder, 7-item (GAD-7) score, which did not differ significantly between arms. C, depression as measured by the Patient Health Questionnaire, 9 (PHQ-9) score, which was also similar between arms. D, Completion rates defined by receiving test results were noninferior in the study arms and were highest in the 2 arms without required pretest counseling. Arm A had no mandatory pretest or posttest counseling, arm B mandated posttest counseling only, arm C was the control group, and arm D mandated pretest counseling only. In panels A, B, and C, the boxes correspond to the first and third quartiles (25th and 75th percentiles of the data), while the bar across represents the median (50th percentile). The lines extending up and down reflect the third quartile plus 1.5 times the IQR and the first quartile minus 1.5 times the IQR. Any points outside this range are plotted individually.
Each of the 3 experimental arms was noninferior to the control arm for distress at 12 months (Figure 3). Similarly, the fraction of individuals with very high distress did not differ significantly between arms at 12 months (Figure 3). When looking at change in the IES score from 3 to 12 months (including only participants who completed both surveys), there was a statistically significant decrease in mean IES score from 3 to 12 months (−1.83 points; 95% CI, −1.83 to −0.54 points; P < .001). There was also a statistically significant decrease in the rate of high distress, from 18.4% at 3 months to 13.8% at 12 months (P < .001; McNemar test).
Figure 3. Distress at 12 Months After Receiving Genetic Testing Results.
A, Distress was not inferior in any of the experimental arms to the control arm at 12 months, consistent with the primary outcome measured at 3 months. The boxes correspond to the first and third quartiles (25th and 75th percentiles of the data), while the bar across represents the median (50th percentile). The lines extending up and down reflect the third quartile plus 1.5 times the IQR and the first quartile minus 1.5 times the IQR. Any points outside this range are plotted individually. B, The proportion of participants with high distress was similar between arms. Arm A had no mandatory pretest or posttest counseling, arm B mandated posttest counseling only, arm C was the control group, and arm D mandated pretest counseling only.
There were no statistically significant differences between the study arms in rates of depression, anxiety, or decisional regret at 3 months (Figure 2 and eTable 3 in Supplement 2). Regarding the decision to undergo genetic testing, most participants had a decision regret score of 0 (no regret) in all arms (eFigure 2 in Supplement 2). Participants with a reported PV had a significantly different change in distress (mean increase of 0.66 points on the IES scale) vs those without a PV (average decrease of 3.5 on the IES scale; P = .003; 2-sample t test of change in IES scores from baseline to 3 months). We ran a 2-way analysis of variance with IES change for PV status (yes vs no), study arm, and their interaction. Status of PV was significant (η2p = 0.006; P = .001) while arm and the interaction of PV status and arm were not, although the small number of participants with PVs limits statistical power to detect an interaction effect.
The completion rates by arm were 76.9% in arm A, 78.6% in arm B, 69.2% in the control arm C, and 66.4% in arm D (Figure 2D and eTable 4 in Supplement 2). We have evidence to reject both secondary hypotheses regarding completion rates, as the upper end of the 98.75% 1-sided CIs for the differences of interest were both less than 6%, indicating that the completion rates in the arms without pretest or posttest telephone counseling were noninferior. When broken down by the 2 cohorts, the patterns were similar, with the highest completion rates occurring in the 2 arms not requiring pretest counseling (Figure 2D and eTable 4 in Supplement 2).
The completion rate was higher for the family history cohort (74.1%) compared with the familial PV cohort (66.8%; P < .001). The increased participant dropout in the familial PV cohort occurred secondary to increased attrition at 2 steps: from randomization to ordering of the test kit (pretest) and from submission of the kit to receiving results (posttest) (eTable 6 in Supplement 2). We evaluated whether age and race and ethnicity were associated with dropout (ie, comparing participants who were randomized but did not complete testing vs those who did). Age was not associated with completion. Non-Hispanic White racial status was associated with increased test completion (odds ratio, 1.37; 95% CI, 1.05-1.78; P = .02), and non-Hispanic Black racial status was associated with decreased test completion (odds ratio, 0.63; 95% CI, 0.41-0.98; P = .03). Lower test completion was also reflected in lower completion of 3-month questionnaires (eTable 6 in Supplement 2).
Next, we evaluated whether baseline distress, anxiety, or depression was associated with low completion of testing. The median baseline distress (total IES score) for participants who completed testing was 9 (mean, 13.2), and the median for those who did not complete testing was also 9 (mean, 13.4) (P = .91; Mann-Whitney test). Higher baseline anxiety (GAD-7 score) was associated with decreased test completion. The median GAD-7 score at baseline in participants who completed testing was 3, and in those who did not complete testing the median score was 4. Higher baseline depression (PHQ-9 score) was also associated with decreased test completion. The median PHQ-9 score at baseline in participants who completed testing was 2, and in those who did not complete testing the median score was 3.
Discussion
To our knowledge, MAGENTA is the first large randomized clinical trial evaluating the effect of individualized pretest and posttest counseling for cancer risk assessment while providing electronic enrollment, remote testing, and counseling. In an effort to assess psychological morbidity, our primary outcome was distress at 3 months using the IES for cancer-specific worry. The experimental arms were noninferior to the control arm for distress in the primary cohort (family history) as well as in the secondary (familial PV) cohort, supporting the option of a less-intensive counseling approach in the provision of cancer genetic risk assessment. Most previous randomized clinical trials related to cancer risk assessment2,28,29,30,31,32 have involved adding tools or techniques for genetic counseling but have not specifically addressed the need for individualized counseling. Telephone counseling has been equivalent to in-person genetic counseling in several randomized clinical trials,11,13,14,33 and therefore telephone counseling was used for our control arms. While MAGENTA was powered to show noninferiority for the primary outcome in the family history cohort, our findings were similar in the familial PV cohort and were maintained at 12 months of follow-up. In addition to the primary outcome of distress, eliminating pretest and/or posttest individual counseling did not increase anxiety or depression or negatively impact completion rates. Together, these outcomes support an alternative model for genetic testing delivery with pretest information provided electronically and posttest counseling for those with PVs and on demand for those without PVs. We plan to follow up the impact on important health behaviors, such as cancer screening and family communication, which are frequent topics emphasized during genetic counseling. The traditional clinical paradigm of mandatory individualized pretest and posttest counseling may introduce barriers to genetic services for some patients, including increased appointments and time, increased cost, and inadequate access to trained genetics professionals. Eliminating mandatory counseling will provide more flexibility for patients and reduce costs.
An important secondary outcome was completion rate, defined as the percentage of randomized participants who received their results. Eliminating pretest and/or posttest counseling was noninferior. Randomization required completing an extensive list of surveys, so presumably this was a highly selected and motivated cohort, and testing was provided without cost. Nevertheless, the highest completion rates occurred in the 2 arms that did not mandate pretest counseling, suggesting that even in the setting of remote care delivery and telephone counseling, the requirement for pretest genetic counseling may serve as a barrier. Participants with higher baseline anxiety or depression, but not distress, had significantly lower completion rates, but that finding did not vary by arm.
The PV rate for participants who completed sequencing was 3.2% in the family history cohort and 5.5% in the familial PV cohort, overall indicating that this was not a very high-risk population for genetic risk. In the family history cohort, the most common genes in which PVs were reported were ATM and CHEK2, followed by BRIP1, BRCA1, and BRCA2. ATM and CHEK2 are the genes in which one finds the most PVs in an unselected population,34 supporting our conclusion that this was not a particularly high-risk population. In contrast, in the familial PV cohort, the most common genes in which variants were reported were BRCA1 and BRCA2. The lower-than-expected variant rate in the familial PV cohort has several explanations. First, we did not require the relative with a variant to be a first-degree relative. Second, in a desire to promote familial PV testing widely, we did not request or verify information on the supposed variant in the family, so some participants may not have truly had a biological relative with a germline PV.
We sought to increase the diversity of our study population with targeted social media advertising and traditional locoregional news stories.35 Despite these efforts, the overall study population remained mostly homogeneous, well educated and White, highlighting the need for alternative community engagement strategies to promote broader use of genetic testing for cancer risk. In a systematic review on racial and ethnic differences in knowledge and attitudes about genetic testing, Canedo et al36 found that Black, Hispanic/Latino, and other racial and ethnic minority group individuals generally had more concerns about genetic testing than White individuals, which may have limited our ability to enroll participants from racial and ethnic minority groups in this recruitment model. Additionally, recruiting through media may have introduced a bias toward higher health literacy. Our findings, therefore, may not be generalizable to other populations. Studies specifically targeting rural, racial and ethnic minority groups, and low health literacy populations are needed to address how best to equitably provide cancer genetic risk assessment, and qualitative studies are needed to define preferences for delivery of genetic care. Additionally, this trial enrolled only women and therefore our findings may not be applicable to men. Genetic testing in this trial was provided free of charge, which is likely to have motivated some individuals to enroll, but may also limit applicability in the community setting.
Our participant population was also mostly cancer-free and low risk (judged by the modest PV rate). Our results may therefore be most relevant to efforts to increase access through population testing. Hardy et al37 recently evaluated preferences for population testing in Ashkenazi Jewish individuals unaffected by cancer; most preferred no genetic counseling (51%) or remote counseling (34.5%), and few preferred in-person counseling (14.5%). Our data suggest that honoring a preference by low-risk patients to skip counseling will not increase distress.
Limitations
This study has limitations. The relatively younger age of the population may limit the generalizability of the conclusions to older individuals. Beri et al38 reported that a minority of patients have a strong preference for in-person communication, but that some older patients and those with greater distress prefer in-person counseling. We agree with these authors that “requests for in-person disclosure should be honored when possible.”39 Peshkin et al39 found that telephone counseling is associated with similar satisfaction, but with a perception of increased convenience. Telehealth delivery of genetic counseling became standard for many centers during the COVID-19 pandemic. Not mandating individualized pretest counseling for all individuals and posttest counseling for those without PVs can increase delivery options for genetic testing while reducing cost.
Conclusions
In this randomized clinical trial, providing results electronically to patients with negative genetic testing results, including those with variants of uncertain significance, did not appear to increase distress in low-risk patients, with posttest genetic counseling provided on demand unless there is an identified PV. Critically, more work needs to be done with patients with low health literacy to verify that skipping counseling does not cause harm. In developing models for population testing, we propose a patient-centric genetic testing model in which patients are provided the option whether to receive pretest and/or posttest genetic counseling as well as the option for remote testing.
Trial Protocol
eMethods. Detailed Methods
eReferences
eTable 1. Eligibility Criteria
eTable 2. Demographic Breakdown by Study Arm
eTable 3. The Means and Standard Deviations (SD) by Arm for Continuous Outcomes With Sample Size Available per Arm at Given Timepoint
eTable 4. Analyses for Binary Outcomes, Along With Sample Sizes for Each Arm at Given Timepoints
eTable 5. Comparison of Participants Who Completed or Did Not Complete the 3-Month Questionnaires for the Primary Outcome
eTable 6. Subject Screening, Enrollment and Completion of Each Step With Breakdown by Cohort Enrollment
eFigure 1. Geographic Distribution of Subjects in MAGENTA
eFigure 2. Psychological Outcomes at 3 Months Post-Receipt of Genetic Testing Results
Data Sharing Statement
References
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Trial Protocol
eMethods. Detailed Methods
eReferences
eTable 1. Eligibility Criteria
eTable 2. Demographic Breakdown by Study Arm
eTable 3. The Means and Standard Deviations (SD) by Arm for Continuous Outcomes With Sample Size Available per Arm at Given Timepoint
eTable 4. Analyses for Binary Outcomes, Along With Sample Sizes for Each Arm at Given Timepoints
eTable 5. Comparison of Participants Who Completed or Did Not Complete the 3-Month Questionnaires for the Primary Outcome
eTable 6. Subject Screening, Enrollment and Completion of Each Step With Breakdown by Cohort Enrollment
eFigure 1. Geographic Distribution of Subjects in MAGENTA
eFigure 2. Psychological Outcomes at 3 Months Post-Receipt of Genetic Testing Results
Data Sharing Statement