A Randomized Trial of Two Remote Health Care Delivery Models on the Uptake of Genetic Testing and Impact on Patient-Reported Psychological Outcomes in Families With Pancreatic Cancer: The Genetic Education, Risk Assessment, and Testing (GENERATE) Study.

BACKGROUND & AIMS: Genetic testing uptake for cancer susceptibility in family members of patients with cancer is suboptimal. Among relatives of patients with pancreatic ductal adenocarcinoma (PDAC), The GENetic Education, Risk Assessment, and TEsting (GENERATE) study evaluated 2 online genetic education/testing delivery models and their impact on patient-reported psychological outcomes. METHODS: Eligible participants had ≥1 first-degree relative with PDAC, or ≥1 first-/second-degree relative with PDAC with a known pathogenic germline variant in 1 of 13 PDAC predisposition genes. Participants were randomized by family, between May 8, 2019, and June 1, 2021. Arm 1 participants underwent a remote interactive telemedicine session and online genetic education. Arm 2 participants were offered online genetic education only. All participants were offered germline testing. The primary outcome was genetic testing uptake, compared by permutation tests and mixed-effects logistic regression models. We hypothesized that Arm 1 participants would have a higher genetic testing uptake than Arm 2. Validated surveys were administered to assess patient-reported anxiety, depression, and cancer worry at baseline and 3 months postintervention. RESULTS: A total of 424 families were randomized, including 601 participants (n = 296 Arm 1; n = 305 Arm 2), 90% of whom completed genetic testing (Arm 1 [87%]; Arm 2 [93%], P = .014). Arm 1 participants were significantly less likely to complete genetic testing compared with Arm 2 participants (adjusted ratio [Arm1/Arm2] 0.90, 95% confidence interval 0.78-0.98). Among participants who completed patient-reported psychological outcomes questionnaires (Arm 1 [n = 194]; Arm 2 [n = 206]), the intervention did not affect mean anxiety, depression, or cancer worry scores. CONCLUSIONS: Remote genetic education and testing can be a successful and complementary option for delivering genetics care. (Clinicaltrials.gov, number NCT03762590).

Implementing a Population-Based Breast Cancer Risk Assessment Program.

BACKGROUND: Personalized breast cancer risk assessment is important in identifying and managing women at increased risk for breast cancer. However, there has been little evaluation of the practical aspects of implementing a population-based program that identifies and refers high-risk patients for further evaluation. PATIENTS AND METHODS: We implemented a semiautomated approach to collect personal and family history to identify women at high risk of breast cancer. On the basis of the survey, women identified as elevated risk received letters inviting them to telephone consultations with licensed breast health genetic counselors (BHGCs). High-risk women's history was verified and counseling and referrals provided, as appropriate. RESULTS: Among 20,558 women screened, 2000 (9.7%) women were identified as high risk on the basis of patient initial report. However, most (1,580) were excluded from receiving risk communication after BHGC review of risk information with the woman or because of previous attention to breast cancer risk or an abnormal mammogram. Among 420 subjects who received risk letters, 225 received a BHGC consultation. Of these 225 women, 63 were reclassified as average risk, 158 were referred to high-risk clinics, and 5 consultations were incomplete after determining that further information was needed. Of the 158 women referred to high-risk breast clinics, 51 attended an appointment. CONCLUSION: This study highlights the complex nature of a population-based breast cancer screening program in a clinical setting and shows the substantial effort needed to identify newly discovered women at high risk for breast cancer and refer them to appropriate services.

NCCN Guidelines Insights: Genetic/Familial High-Risk Assessment: Breast and Ovarian, Version 2.2017.

The NCCN Clinical Practice Guidelines in Oncology for Genetic/Familial High-Risk Assessment: Breast and Ovarian provide recommendations for genetic testing and counseling for hereditary cancer syndromes and risk management recommendations for patients who are diagnosed with a syndrome. Guidelines focus on syndromes associated with an increased risk of breast and/or ovarian cancer. The NCCN Genetic/Familial High-Risk Assessment: Breast and Ovarian panel meets at least annually to review comments from reviewers within their institutions, examine relevant new data from publications and abstracts, and reevaluate and update their recommendations. The NCCN Guidelines Insights summarize the panel's discussion and most recent recommendations regarding risk management for carriers of moderately penetrant genetic mutations associated with breast and/or ovarian cancer.

Genetic/Familial High-Risk Assessment: Breast and Ovarian, Version 2.2015.

The NCCN Guidelines for Genetic/Familial High-Risk Assessment: Breast and Ovarian provide recommendations for genetic testing and counseling and risk assessment and management for hereditary cancer syndromes. Guidelines focus on syndromes associated with an increased risk of breast and/or ovarian cancer and are intended to assist with clinical and shared decision-making. These NCCN Guidelines Insights summarize major discussion points of the 2015 NCCN Genetic/Familial High-Risk Assessment: Breast and Ovarian panel meeting. Major discussion topics this year included multigene testing, risk management recommendations for less common genetic mutations, and salpingectomy for ovarian cancer risk reduction. The panel also discussed revisions to genetic testing criteria that take into account ovarian cancer histology and personal history of pancreatic cancer.

Participation of low-income women in genetic cancer risk assessment and BRCA 1/2 testing: the experience of a safety-net institution.

Some communities and populations lack access to genetic cancer risk assessment (GCRA) and testing. This is particularly evident in safety-net institutions, which serve a large segment of low-income, uninsured individuals. We describe the experience of a safety-net clinic with limited resources in providing GCRA and BRCA1/2 testing. We compared the proportion and characteristics of high-risk women who were offered and underwent GCRA and genetic testing. We also provide a description of the mutation profile for affected women. All 125 patients who were offered GCRA accepted to undergo GCRA. Of these, 72 % had a breast cancer diagnosis, 70 % were Hispanic, 52.8 % were non-English speakers, and 66 % did not have health insurance. Eighty four (67 %) were offered genetic testing and 81 (96 %) agreed. Hispanic women, those with no medical insurance, and those with a family history of breast cancer were significantly more likely to undergo testing (p > 0.01). Twelve of 81 (15 %) patients were found to have deleterious mutations, seven BRCA1, and five BRCA2. Our experience shows that it is possible to offer GCRA and genetic testing even in the setting of limited resources for these services. This is important given that a large majority of the low-income women in our study agreed to undergo counseling and testing. Our experience could serve as a model for similar low-resource safety-net health settings.

Genetic/familial high-risk assessment: breast and ovarian, version 1.2014.

During the past few years, several genetic aberrations that may contribute to increased risks for development of breast and/or ovarian cancers have been identified. The NCCN Guidelines for Genetic/Familial High-Risk Assessment: Breast and Ovarian focus specifically on the assessment of genetic mutations in BRCA1/BRCA2, TP53, and PTEN, and recommend approaches to genetic testing/counseling and management strategies in individuals with these mutations. This portion of the NCCN Guidelines includes recommendations regarding diagnostic criteria and management of patients with Cowden Syndrome/PTEN hamartoma tumor syndrome.

Characteristics of genomic test consumers who spontaneously share results with their health care provider.

The purpose of this study was to evaluate the characteristics of direct-to-consumer (DTC) genomic test consumers who spontaneously shared their test results with their health care provider. Utilizing data from the Scripps Genomic Health Initiative, we compared demographic, behavioral, and attitudinal characteristics of DTC genomic test consumers who shared their results with their physician or health care provider versus those who did not share. We also compared genomic risk estimates between the two groups. Of 2,024 individuals assessed at approximately 6 months post testing, 540 individuals (26.5%) reported sharing their results with their physician or health care provider. Those who shared were older (p < .001), had a higher income (p = .01), were more likely to be married (p = .005), and were more likely to identify with a religion (p = .004). As assessed prior to undergoing testing, sharers also reported higher levels of exercise (p = .003), lower fat intake (p = .02), fewer overall concerns about testing (p = .001), and fewer concerns related to the privacy of their genomic information (p = .03). The genomic disease risk estimates disclosed were not associated with sharing. Thus, in a DTC genomic testing context, physicians and other health care providers may be more likely to encounter patients who are more health conscious and have fewer concerns about the privacy of their genomic information. Genomic risk itself does not appear to be a primary determinant of sharing behavior among consumers.

Classification of CAM use and its correlates in patients with early-stage breast cancer.

HYPOTHESIS: Self-reported use of complementary and alternative medicine (CAM) has been shown to increase following a cancer diagnosis, and breast cancer survivors are the heaviest users among cancer survivors. The aim of this study was to determine whether the prevalence estimate of CAM use varied according to classification of CAM. The authors used a comprehensive system to classify CAM users and test differences in demographic, lifestyle, quality of life, and cancer characteristics among them. STUDY DESIGN AND METHODS: Participants were 2562 breast cancer survivors participating in the Women's Healthy Eating and Living (WHEL) Study, aged 28 to 74 years. A structured telephone interview assessed CAM use, questioning about specific CAM practices, and whether use was related to cancer. This study examined CAM use in relation to demographics, health behaviors, and quality of life. RESULTS: Approximately 80% of the women used CAM for general purposes but only 50% reported CAM use for cancer purposes. Visual imagery, spiritual healing, and meditation were the most frequently used practices for cancer purposes. CAM use, defined as consulting a CAM practitioner and regular use, was significantly related to younger age, higher education, increased fruit and vegetable intake, and lower body mass index (P < .05). CAM users who had seen a practitioner were also more likely to report poor physical and mental health than non-CAM users (P < .05). CAM use was not associated with changes in physical and mental health between study baseline and 1-year follow-up. CONCLUSION: This study addressed important differences in the classification of CAM use among breast cancer survivors. Future studies need to further test the potential benefits and risks associated with CAM use.

Adopting a plant-based diet minimally increased food costs in WHEL Study.

OBJECTIVE: To assess the cost of adopting a plant-based diet. METHODS: Breast cancer survivors randomized to dietary intervention (n=1109) or comparison (n=1145) group; baseline and 12-month data on diet and grocery costs. RESULTS: At baseline, both groups reported similar food costs and dietary intake. At 12 months, only the intervention group changed their diet (vegetable-fruit: 6.3 to 8.9 serv/d.; fiber: 21.6 to 29.8 g/d; fat: 28.2 to 22.3% of E). The intervention change was associated with a significant increase of $1.22/ person/week (multivariate model, P=0.027). CONCLUSIONS: A major change to a plant-based diet was associated with a minimal increase in grocery costs.

Health parties for African American study recruitment.

Innovative strategies are needed to increase minorities' research participation. Using existing social networks within the African American community, "home health parties" were tested as a way to recruit African American women to a breast cancer control study. Parties included social, educational, and recruitment components. All women attending health parties consented, completed a survey, and received the study's preliminary breast cancer risk assessment. There were no differences in rates of participation for subsequent study components between women recruited via parties versus other methods. Health parties are viable recruitment strategies, reduce barriers to participation, provide a supportive environment, and are relatively inexpensive.

Antidepressant prescribing in community cancer care.

GOALS: To describe patterns of antidepressant (ADs) prescribing in community oncology practice. PATIENTS AND METHODS: Data were collected using an electronic medical record on all staged breast, colon, and lung cancer patients in three community-based oncology practices. The data were analyzed retrospectively, using descriptive and bivariate analyses and multivariate logistic regression modeling. There were 850 breast, 299 colon, and 473 lung cancer patients identified in this analysis. MAIN RESULTS: Overall, 19.2% of breast, 11% of colon, and 13.7% of lung cancer patients had been prescribed ADs during the 2-year period. The clinic in which cancer treatment was received predicted AD prescribing. The relationship between AD administration and age proved to be nonlinear; the pattern exhibited an "inverted U" shape. Patients with comorbidities and on pain medications were more likely to be administered ADs. Colon cancer patients on pain medications were five times more likely to be administered ADs than those not on pain medications. CONCLUSIONS: While some predictors of AD prescribing appear to be consistent with other studies, such as being on pain medication, there is still a great amount of variability in prescribing patterns across community practices, age groups, and cancer diagnoses. This study demonstrates that prescriptions of ADs seem to be influenced by parameters other than psychopathology. Given the importance of major depression in oncology care, diagnosis of psychiatric disorders and prescription patterns of psychotropics should be part of the routine monitoring and quality management in oncology patient care.