Telephone Disclosure Research Articles

Ethical, legal, and social implications (ELSI) and challenges in the design of a randomized controlled trial to test the online return of cancer genetic research results to U.S. Black women

BackgroundA central challenge to precision medicine research efforts is the return of genetic research results in a manner that is effective, ethical, and efficient. Formal tests of alternate modalities are needed, particularly for racially marginalized populations that have historically been underserved in this context. MethodsWe are conducting a randomized controlled trial (RCT) to test scalable modalities for results return and to examine the clinical utility of returning genetic research results to a research cohort of Black women. The primary aim is to compare the efficacy of two communication modalities for results return: 1) a conventional modality that entails telephone disclosure by a Board-certified genetic counselor, and 2) an online self-guided modality that entails results return directly to participants, with optional genetic counselor follow-up via telephone. The trial is being conducted among participants in the Black Women's Health Study (BWHS), where targeted sequencing of 4000 participants was previously completed. ResultsSeveral ethical, legal, and social implications (ELSI) and challenges presented, which necessitated substantial revision of the original study protocol. Challenges included chain of custody, re-testing of research results in a CLIA lab, exclusion of VUS results, and digital literacy. Bioethical principles of autonomy, justice, non-maleficence, and beneficence were considered in the design of the study protocol. ConclusionThis study is uniquely situated to provide critical evidence on the effectiveness of alternative models for genetic results return and provide further insight into the factors influencing access and uptake of genetic information among U.S. Black women.Clinicaltrials.gov: NCT04407611

Is it okay to choose to receive bad news by telephone? An observational study on psychosocial consequences of diagnostic workup for lung cancer suspicion

Background In-person meeting is considered the gold standard in current communication protocols regarding sensitive information, yet one size may not fit all, and patients increasingly demand or are offered disclosure of bad news by, e.g., telephone. It is unknown how patients’ active preference for communication modality affect psychosocial consequences of receiving potentially bad news. Aim To explore psychosocial consequences in patients, who themselves chose to have results of lung cancer workup delivered either in-person or by telephone compared with patients randomly assigned to either delivery in a recently published randomised controlled trial (RCT). Methods An observational study prospectively including patients referred for invasive workup for suspected lung cancer stratified in those declining (Patient’s Own Choice, POC group) and those participating in the RCT. On the day of invasive workup and five weeks later, patients completed a validated, nine-dimension, condition-specific questionnaire, Consequences of Screening in Lung Cancer (COS-LC). Primary outcome: difference in change in COS-LC dimensions between POC and RCT groups. Results In total, 151 patients were included in the POC group versus 255 in the RCT. Most (70%) in the POC group chose to have results by telephone. Baseline characteristics and diagnostic outcomes were comparable between POC and RCT groups, and in telephone and in-person subgroups too. We observed no statistically significant between-groups differences in any COS-LC score between POC and RCT groups, or between telephone and in-person subgroups in the POC group. Conclusion Continually informed patients’ choice between in-person or telephone disclosure of results of lung cancer workup is not associated with differences in psychosocial outcomes. The present article supports further use of a simple model for how to prepare the patient for potential bad news.

Longitudinal follow-up after telephone disclosure in the randomized COGENT study

PurposeTo better understand the longitudinal risks and benefits of telephone disclosure of genetic test results in the era of multigene panel testing. MethodsAdults who were proceeding with germline cancer genetic testing were randomized to telephone disclosure (TD) with a genetic counselor or in-person disclosure (IPD) (i.e., usual care) of test results. All participants who received TD were recommended to return to meet with a physician to discuss medical management recommendations. ResultsFour hundred seventy-three participants were randomized to TD and 497 to IPD. There were no differences between arms for any cognitive, affective, or behavioral outcomes at 6 and 12 months. Only 50% of participants in the TD arm returned for the medical follow-up appointment. Returning was associated with site (p<0.0001), being female (p=0.047), and not having a true negative result (p<0.002). Mammography was lower at 12 months among those who had TD and did not return for medical follow-up (70%) compared with those who had TD and returned (86%) and those who had IPD (87%, adjusted p<0.01). ConclusionTelephone disclosure of genetic test results is a reasonable alternative to in-person disclosure, but attention to medical follow-up may remain important for optimizing appropriate use of genetic results.

CONNECT 4 APOE: A RANDOMIZED STUDY OF PHONE VERSUS VIDEOCONFERENCE DELIVERY OF APOE GENOTYPE DISCLOSURE IN THE GENERATION STUDY

APOE testing is increasingly important to identify candidates eligible for Alzheimer's trials. How best to provide genetic services for the disclosure of APOE results remains unclear. Both telephone and real-time videoconferencing (RTVC) have been shown to be feasible for remote delivery of genetic services, but outcomes have not been compared in a randomized trial. The Alzheimer's Prevention Initiative Generation Study 1 (NCT02565511) is enrolling cognitively normal APOE e4 homozygotes aged 60–75 years and includes a standardized approach to APOE disclosure. Some study sites do not have genetic providers to provide counseling and test disclosure to participants. CONNECT 4 APOE (NCT02978729) is a multi-site randomized study to evaluate the relative advantages of RTVC disclosure over telephone for disclosure of APOE genotype results in a large clinical trial. Participants are randomized to disclosure of results by phone or RTVC; counselors use standardized counseling checklists, risk estimates and visual aids. Knowledge and psychosocial outcomes are measured at various time points. In a planned interim analysis, 410 participants have been randomized (201 to RTVC, 209 to phone disclosure). Mean participant age is 67 years, 64% are female, 93% white, and >99% have a family history of dementia. 124 (31%) are APOE e4 homozygotes and 157 (39%) are heterozygotes. Participant characteristics and APOE results did not differ significantly between arms. In this early planned analysis, there were no statistically significant differences in change in any measured outcome from baseline to 2–7 days or 6 weeks post-disclosure (Table 1). Those in the telephone arm reported less increase in disease specific-distress, although this was not statistically significant. Satisfaction with services was slightly higher in the telephone disclosure arm post-disclosure (0.8 higher in telephone arm, p=0.07). Further analysis by APOE result (heterozygote v. homozygote v. noncarrier) will be completed to better understand if outcomes are similar by test result.

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

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.

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

Germline genetic testing is standard practice in oncology. Outcomes of telephone disclosure of a wide range of cancer genetic test results, including multigene panel testing (MGPT) are unknown. Patients undergoing cancer genetic testing were recruited to a multicenter, randomized, noninferiority trial (NCT01736345) comparing telephone disclosure (TD) of genetic test results with usual care, in-person disclosure (IPD) after tiered-binned in-person pretest counseling. Primary noninferiority outcomes included change in knowledge, state anxiety, and general anxiety. Secondary outcomes included cancer-specific distress, depression, uncertainty, satisfaction, and screening and risk-reducing surgery intentions. To declare noninferiority, we calculated the 98.3% one-sided confidence interval of the standardized effect; t tests were used for secondary subgroup analyses. Only noninferiority tests were one-sided, others were two-sided. A total of 1178 patients enrolled in the study. Two hundred eight (17.7%) participants declined random assignment due to a preference for in-person disclosure; 473 participants were randomly assigned to TD and 497 to IPD; 291 (30.0%) had MGPT. TD was noninferior to IPD for general and state anxiety and all secondary outcomes immediately postdisclosure. TD did not meet the noninferiority threshold for knowledge in the primary analysis, but it did meet the threshold in the multiple imputation analysis. In secondary analyses, there were no statistically significant differences between arms in screening and risk-reducing surgery intentions, and no statistically significant differences in outcomes by arm among those who had MGPT. In subgroup analyses, patients with a positive result had statistically significantly greater decreases in general anxiety with telephone disclosure (TD -0.37 vs IPD +0.87, P = .02). 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.

A randomized controlled trial of disclosing genetic risk information for Alzheimer disease via telephone.

PurposeTelephone disclosure of genetic test results can improve access to services. To date, studies of its impact have focused on return of Mendelian risk information, principally hereditary cancer syndromes.MethodsIn a multisite trial of Alzheimer’s disease genetic risk disclosure, asymptomatic adults were randomized to receive test results in-person or via telephone. Primary analyses examined patient outcomes 12 months after disclosure.ResultsData from 257 participants showed that telephone disclosure occurred 7.4 days sooner and were 30% shorter, on average, than in-person disclosure (both p<0.001). Anxiety and depression scores were well below cutoffs for clinical concern across protocols. Comparing telephone and in-person disclosure protocols, 99% CIs of mean differences were within non-inferiority margins on scales assessing anxiety, depression, and test-related distress, but inconclusive about positive impact. No differences were observed on measures of recall and subjective impact. Sub-analyses supported non-inferiority on all outcomes among APOE ε4-negative participants. Sub-analyses were inconclusive for APOE ε4-positive participants, although mean anxiety and depression scores were still well below cutoffs for clinical concern.ConclusionTelephone disclosure of APOE results and risk for Alzheimer’s disease is generally safe and helps providers meet demands for services, even when results identify an increased risk for disease.

Knowledge outcomes in a randomized trial of telephone vs. in-person disclosure of genetic testing: The COGENT study.

1534 Background: Telephone disclosure (TD) of genetic testing is non-inferior to in-person disclosure (IPD) for most outcomes but did not meet non-inferiority for knowledge change. We sought to understand which concepts patients don’t understand and factors associated with lower knowledge. Methods: Patients were recruited to a multi-center, randomized trial (NCT01736345) comparing TD to IPD of genetic test results. 819 patients were randomized (IPD = 418; TD = 401); 165 declined randomization and requested IPD. Knowledge was assessed after pre-test counseling (V1) and test disclosure (V2). Results: There were no significant differences in genetic or multi-gene (MG) knowledge between disclosure groups after V1 and V2. On average, patients answered 73% (SD 1.19) of genetic knowledge and 57% (SD 1.78) of mg knowledge items correctly.After V1, most understood implications of a positive result (87%), that results are not deterministic (84%) and risks for their children (91%). Understanding of uninformative negative, true negative and variant of uncertain significance (VUS) results was lower (post-V1: 33%, 65%, 29%; post-V2 : 37%, 65%, 25%). In multivariable analyses, lower genetic knowledge after V1 was associated with study site, being older (p &lt; 0.01), single (p &lt; 0.01), non-white (p &lt; 0.01), not Ashkenazi Jewish (p = 0.01), and not having a mutation in the family (p = 0.03), having more relatives with cancer (p &lt; 0.01) and not graduating college (p &lt; 0.01). Lower mg knowledge after V1 was associated with site and being non-white (p = 0.01). Lower genetic knowledge after V2 was not associated with disclosure method but associated with study site, being older (p &lt; 0.01), not graduating college (p &lt; 0.01) and being non-white (p &lt; 0.01). Lower mg knowledge after V2 was only associated with not graduating college (p = 0.02). Conclusions: While there were no significant differences in genetic knowledge by disclosure method, understanding of several concepts (e.g. VUS and negative results) were lower regardless of arm. Several factors, including age, education and race/ethnicity were associated with lower knowledge. Interventions to improve genetic knowledge in real-world and diverse populations are needed. Clinical trial information: NCT07136345.

Extended follow-up in the COGENT study: A randomized study of in-person versus telephone disclosure of cancer genetic test results.

1504 Background: Alternative delivery models are needed in the era of Precision Medicine given a shortage of genetic providers and increasing utilization of genetic testing. Telephone disclosure (TD) of genetic test results, including multi-gene panel testing, is non-inferior to usual care in-person disclosure (IPD) for short-term distress but failed non-inferiority for knowledge. Longitudinal data including health behaviors are needed. Methods: 970 patients undergoing clinical genetic testing at 5 centers were randomly assigned to usual care IPD (n = 497) or TD (n = 473) of results in the COGENT Study (NCT01736345). Participants completed surveys after pre-test counseling, post-disclosure and at 6 and 12 months. We used non-inferiority tests for primary analyses and T-tests and logistic regressions for secondary analyses. Results: TD was not worse than IPD for anxiety both post-disclosure and at 6 months, but did not reach the non-inferiority threshold for knowledge at either time point. In secondary analyses there were no significant differences in anxiety, depression, or cancer worry between arms, but there was less knowledge gain at 6 (-0.41 v. +0.11 in IPD, p = 0.05) and 12 months (-0.34 v. +0.31 in IPD, p = 0.05) in the TD arm. In the TD arm, 195 (50%) returned for clinical follow-up with a physician to discuss medical management. Not returning for follow-up varied by site and was associated with a negative result, being male and non-white. Knowledge gain at 6 months was lower for those who did not return for follow-up (-0.77) compared to those who returned (-0.17, p = 0.08). There were no significant differences by arm at 6 and 12 months in performance of mammogram, breast MRI, colonoscopy or prophylactic surgeries. Conclusions: Distress is not unacceptably worse with TD, but knowledge failed the test for non-inferiority. Longitudinal knowledge declined more for those who did not return for medical follow-up, but uptake of screening and risk reducing behaviors did not differ by arm. Telephone disclosure of genetic test results, even MGPT, may be a reasonable alternative to in-person disclosure for patients who agree to return to meet with a provider for medical management recommendations. Clinical trial information: NCT01736345.

Patient-reported outcomes in a multicenter randomized study of in-person versus telephone disclosure of genetic test results for cancer susceptibility.

1502Background: Genetic testing for cancer predisposition traditionally includes in-person pre- and post-test genetic counseling. Outcomes of telephone delivery of a range of cancer genetic test re...

Development of a communication protocol for telephone disclosure of genetic test results for cancer predisposition.

BackgroundDissemination of genetic testing for disease susceptibility, one application of “personalized medicine”, holds the potential to empower patients and providers through informed risk reduction and prevention recommendations. Genetic testing has become a standard practice in cancer prevention for high-risk populations. Heightened consumer awareness of “cancer genes” and genes for other diseases (eg, cardiovascular and Alzheimer’s disease), as well as the burgeoning availability of increasingly complex genomic tests (ie, multi-gene, whole-exome and -genome sequencing), has escalated interest in and demand for genetic risk assessment and the specialists who provide it. Increasing demand is expected to surpass access to genetic specialists. Thus, there is urgent need to develop effective and efficient models of delivery of genetic information that comparably balance the risks and benefits to the current standard of in-person communication.ObjectiveThe aim of this pilot study was to develop and evaluate a theoretically grounded and rigorously developed protocol for telephone communication of BRCA1/2 (breast cancer) test results that might be generalizable to genetic testing for other hereditary cancer and noncancer syndromes.MethodsStakeholder data, health communication literature, and our theoretical model grounded in Self-Regulation Theory of Health Behavior were used to develop a telephone communication protocol for the communication of BRCA1/2 genetic test results. Framework analysis of selected audiotapes of disclosure sessions and stakeholders’ feedback were utilized to evaluate the efficacy and inform refinements to this protocol.ResultsStakeholder feedback (n=86) and audiotapes (38%, 33/86) of telephone disclosures revealed perceived disadvantages and challenges including environmental factors (eg, non-private environment), patient-related factors (eg, low health literacy), testing-related factors (eg, additional testing needed), and communication factors (eg, no visual cues). Resulting modifications to the communication protocol for BRCA1/2 test results included clarified patient instructions, scheduled appointments, refined visual aids, expanded disclosure checklist items, and enhanced provider training.ConclusionsAnalyses of stakeholders’ experiences and audiotapes of telephone disclosure of BRCA1/2 test results informed revisions to communication strategies and a protocol to enhance patient outcomes when utilizing telephone to disclose genetic test results.

Communication of genetic test results to family and health-care providers following disclosure of research results.

Few studies have examined methods to promote communication following the return of DNA mismatch repair genetic test results obtained during research. The purpose of the present study was to evaluate a telephone protocol for returning research results of DNA mismatch repair gene testing to identify Lynch syndrome. We invited individuals with known DNA mismatch repair mutations in their family, who were enrolled in the Colon Cancer Family Registry at the Mayo Clinic, to participate in this study. Participants completed surveys before and 6 months after DNA mismatch repair test result disclosure. Among 107 participants, 79% opted to learn their DNA mismatch repair test results; of these, 44 (41%) carried DNA mismatch repair mutations. After disclosure, 54% reported screening for any type of cancer. Among carriers, >74% reported communicating results to family; communication was predicted by baseline confidence in coping with the genetic test result (Z = 1.97; P = 0.04). Result disclosure to a physician was predicted by greater perceived cancer risk (Z = 2.08; P = 0.03) and greater intention to share results with family (Z = 3.07; P = 0.002). Research versus clinically based gene disclosure presents challenges. A telephone disclosure process for the return of research-based results among Lynch syndrome families led to high rates of result uptake and participant communication of results to providers and family members.

Implementation and outcomes of telephone disclosure of clinical BRCA1/2 test results

ObjectivesWith an increasing demand for genetic services, effective and efficient delivery models for genetic testing are needed. MethodsIn this prospective single-arm communication study, participants received clinical BRCA1/2 results by telephone with a genetic counselor and completed surveys at baseline, after telephone disclosure (TD) and after in-person clinical follow-up. ResultsSixty percent of women agreed to participate; 73% of decliners preferred in-person communication. Anxiety decreased from baseline to post-TD (p=0.03) and satisfaction increased (p<0.01). Knowledge did not change significantly from baseline to post-TD, but was higher post-clinical follow-up (p=0.04). Cancer patients had greater declines in state anxiety and African-American participants reported less increase in satisfaction. 28% of participants did not return for in-person clinical follow-up, particularly those with less formal education, and higher post-disclosure anxiety and depression (p<0.01). ConclusionsTelephone disclosure of BRCA1/2 test results may not be associated with negative cognitive and affective responses among willing patients, although some subgroups may experience less favorable responses. Some patients do not return for in-person clinical follow-up and longitudinal outcomes are unknown. Practice implicationsFurther evaluation of longitudinal outcomes of telephone disclosure and differences among subgroups can inform how to best incorporate telephone communication into delivery of genetic services.

A randomized trial of telephone versus in-person disclosure of BRCA 1/2 results.

1538 Background: While some providers use telephone to share genetic test results, there is limited data on the efficacy and impact on patient cognitive and emotional responses. Methods: Patients who completed in-person genetic counseling for BRCA 1/2 testing were randomized to telephone (TD) or in-person (IPD) disclosure. Baseline (BL) and post-disclosure (PD) surveys assessed knowledge, satisfaction and psychological factors. We used T-tests and multiple linear regressions. Results: 179 patients (68% of approached),126 (72%) agreed to be randomized; 36 (28%) declined randomization (Self-select IPD). Patient characteristics did not differ between arms. Change in knowledge, satisfaction and psychological factors did not differ between TD and IPD (Table). Self-select IPD participants had greater declines in depression and state anxiety (Table). In multivariable models, history of cancer was associated with greater declines in general anxiety (coef -1.4, p=0.01). BRCA+ results were associated with greater increases in knowledge (coef 3.2, p 0.02) and state anxiety (coef 12.0, p&lt;0.01), and declines in satisfaction (coef -6.6, p&lt;0.01). Having a mutation in the family was associated with greater declines in intrusive thoughts (coef -4.8, p&lt;0.01). Conclusions: In general,telephone disclosure of BRCA1/2 results does not appear to negativelyimpact psychological outcomes but outcomes among carriers (BRCA+) differ. Larger studies are needed to understand the impact among subgroups and more diverse populations. Some patients preferred in-person communication and had different outcomes, suggesting more data is needed before telephone disclose is universally adopted. [Table: see text]

Genetic counselor opinions of, and experiences with telephone communication of BRCA1/2 test results

BRCA1/2 test disclosure has, historically, been conducted in-person by genetics professionals. Given increasing demand for, and access to, genetic testing, interest in telephone and Internet genetic services, including disclosure of test results, has increased. Semi-structured interviews with genetic counselors were conducted to determine interest in, and experiences with telephone disclosure of BRCA1/2 test results. Descriptive data are summarized with response proportions. One hundred and ninety-four genetic counselors completed self-administered surveys via the web. Although 98% had provided BRCA1/2 results by telephone, 77% had never provided pre-test counseling by telephone. Genetic counselors reported perceived advantages and disadvantages to telephone disclosure. Thirty-two percent of participants described experiences that made them question this practice. Genetic counselors more frequently reported discomfort with telephone disclosure of a positive result or variant of uncertain significance (p < 0.01) than other results. Overall, 73% of participants reported interest in telephone disclosure. Many genetic counselors have provided telephone disclosure, however, most, infrequently. Genetic counselors identify potential advantages and disadvantages to telephone disclosure, and recognize the potential for testing and patient factors to impact patient outcomes. Further research evaluating the impact of testing and patient factors on cognitive, affective, social and behavioral outcomes of alternative models of communicating genetic information is warranted.

Controversies in Communication of Genetic Screening Results for Cancer: A Report from the American Society of Preventive Oncology's Screening Special Interest Group (ASPO's 33rd Annual Meeting, March 8 to 10, 2009, Tampa, Florida)

Genetic screening for cancer susceptibility for many cancer sites has become routine for high-risk populations, particularly breast, ovarian, and colon cancer. Such genetic tests hold great promise for informing tailored cancer prevention and risk reduction recommendations. Heightened consumer

Retrospective comparison of patient outcomes after in-person and telephone results disclosure counseling for BRCA1/2 genetic testing

Telephone disclosure of BRCA1/2 molecular genetic test results has been proposed as a feasible alternative to traditional in-person results disclosure. The purpose of this study was to investigate the relationship between method of result disclosure with the patient outcome variables of knowledge, cancer worry, cancer risk perception, satisfaction, and cancer screening and prophylactic surgery behaviors. Study participants included 228 women who completed retrospective, self-administered, mailed surveys regarding their pre-test genetic counseling and results disclosure. No significant relationships were found between result disclosure method and the outcome variables investigated. A majority (90%) of individuals who received positive results by telephone returned for follow up visits. Factors which genetic counselors believed influenced their clinical decision to offer telephone disclosure, such as history of breast cancer, a priori risk of genetic mutation and family history of known mutation were not shown to significantly impact the actual disclosure method. This study suggests that telephone results disclosure is clinically appropriate when counselors utilize their clinical judgment to determine which patients are appropriate candidates.

Telephone disclosure of BRCA1/2 test results? Experience and opinions of genetic counselors and consumers

1510 Background: BRCA1/2 test results have historically been disclosed in person (IPD) by a certified genetic counselor (GC). Greater consumer demand and access to BRCA1/2 testing, and greater prevalence and acceptance of telemedicine, have interested providers in conducting BRCA1/2 testing and disclosing results by telephone (TD) and internet. GC and consumer experiences and opinions about TD have not been well described. Methods: To determine experience, opinions and interest in TD of BRCA1/2 test results we conducted semi-structured interviews with 194 GC recruited via NSGC Cancer Special Interest Group and with 30 consumers (to date) less than 9 months post IPD of BRCA1/2 test results at two cancer centers. Descriptive statistics characterize GC and consumer experiences and opinions. Results: 98% GC had provided TD; 46% rarely. Most frequent reasons for TD: perceived consumer hardship of IPD (n = 190); consumer preference (n = 49) and medical benefit (n = 30). GC comfort with TD varied by test result (true negative [TN] 77%, indeterminate [IND] 49%; mutation carriers [MC] 37%; variant of unknown significance [VUS] 33%). GC cited consumer convenience (n = 132), medical (n = 71) and psychological benefit (n = 42), and greater GC counseling capacity (n = 33) as TD advantages. No nonverbal communication (n = 161), poorer communication/understanding (n = 67), and difficulty explaining complex results (n = 41) were disadvantages GC most frequently reported. 46% post-IPD consumers reported interest in TD; interest varied by test result (VUS 67%; IND, 63%; TN 57%; MC 25%). Consumers’ perceived advantages: convenience (n = 22) and medical benefit (n = 9); and disadvantage to TD; lack of visual and personal connection with GC (n = 18). Conclusions: Results of the ongoing study suggest many consumers of BRCA1/2 testing are interested in, and nearly all GC have conducted, TD. GC and consumers share perceptions of TD convenience, and of challenges of lack of visual cues, however, GC comfort with, and consumer preference for, TD vary differently by test result. Given consumer and provider interest, longitudinal study of TD impact on knowledge, risk perception, communication, and health behaviors, and their mediators will be critical to develop policy and procedures optimizing adaptive responses to TD. No significant financial relationships to disclose.

Telephone disclosure of BRCA1/2 test results? Opinions of recipients of BRCA1/2 testing.

Abstract Abstract #2098 Background: Disclosure of BRCA1/2 test results has historically been conducted in person by a health care professional. Due to increasing consumer demand for, and access to BRCA1/2 testing, as well as the increasing prevalence and acceptance of telemedicine, there has been interest among those who provide BRCA1/2 testing in delivering risk assessment and genetic counseling services, including disclosure of genetic test results, by telephone and internet. Consumers' opinions regarding, and interest in receiving their genetic test results via telephone have not been well described. Method: Conducted semi-structured telephone interviews with individuals who had received BRCA1/2 test results in the last 9 months or were awaiting BRCA1/2 test results to assess opinions about the use of telephone disclosure (TD) among consumers of BRCA1/2 genetic testing. To date: 30 participants interviewed. Results: Although 90% (23/26) of participants who had received their genetic test results reported being satisfied or very satisfied with their in-person disclosure session, 50% reported that they would have been interested in receiving results by telephone. 47% stated they would have preferred in-person disclosure. Interest in TD did vary by test result (interested: mutation carriers 2/7, 29%; VUS 1/3, 33%; true negative 4/8, 50%; indeterminate 5/8, 53%). A greater proportion of men reported interest in TD (3/4, 75%). Interest in TD did not appear to vary by age. In response to open query, the most frequently reported perceived advantage to TD was convenience (n = 10); the most frequently cited perceived disadvantage was lack of visual and personal connection between recipient and provider (n =15). Among those awaiting test results, 3/4 (75%) reported that they would have been interested in TD. 67% would prefer that TD be conducted by a genetic counselor or physician; 57% would prefer a genetic counselor and 10% would prefer a physician. Many (60%) reported that they would be willing to return for an in-person visit, although 24% stated that this would depend upon their results. Discussion: The results of this ongoing study suggest that many consumers of BRCA1/2 testing may be interested in receiving test results by telephone. Continued enrollment at 2 additional sites will allow for multivariate analysis of the biopsychosocial factors associated with consumer interest in TD. Given consumer and provider interest, and the expansion of testing for BRCA1/2 and other hereditary cancer syndromes, longitudinal study of the cognitive, affective and behavioral responses to TD is warranted. Understanding the impact of TD on factors such as, comprehension, risk perception, communication and performance of risk reducing behaviors, and their mediators will be critical for the development of TD policy and procedures that will optimize adaptive responses to receiving genetic test results via telephone or internet. Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 2098.

Telephone disclosure of BRCA1/2 test results: a survey of genetic counselors.

Abstract Abstract #1098 Disclosure of BRCA1/2 test results has historically been conducted in person by a certified genetic counselor (GC) and/or other health care professional. Due to increasing demand for and access to BRCA1/2 testing, there has been interest in providing genetic counseling services, including disclosure of test results, by telephone and internet. The practice of telephone disclosure among certified genetic counselors has not been described. We conducted semi-structured interviews with GCs to determine current prevalence of, and future interest in, telephone disclosure (TD) of BRCA1/2 test results. Surveys were self-administered and completed via a secure web site. Participants were recruited through the NSGC Cancer Special Interest Group. 195 GCs completed the survey (25% response rate). 23% of respondents have provided pre-test counseling by telephone. 98% reported having provided genetic test results by telephone, although many (48%) conduct TD rarely (&amp;lt;25% of the time). 33% reported TD experiences that had made them question TD as a practice. Comfort with TD varied by test result (37% comfortable with TD for positive test results, 77% for true negative results, 49% for indeterminate results and 33% for VUS results). The majority of GCs do not include a physician (85%) in the TD. Many report encouraging in-person follow-up with a GC (44%) and/or physician (30%). Overall, 42% reported being very interested in TD and 73% felt TD could be an acceptable standard practice. These results suggest many genetic counselors have provided genetic test results by phone and are interested in including telephone disclosure of BRCA1/2 test results in their practice. Given provider interest and the expansion of testing for BRCA1/2 and other hereditary cancer syndromes, further research evaluating the cognitive, affective and behavioral responses to telephone disclosure is warranted. Understanding the impact of telephone disclosure on factors such as, comprehension, risk perception, communication and performance of risk reducing behaviors and their mediators will be critical for the development of telephone disclosure policy and procedures that will optimize adaptive responses to receiving genetic test results via telephone or internet. Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 1098.