Predictors of contralateral prophylactic mastectomy in genetically high risk newly diagnosed breast cancer patients.

PURPOSE: Recent trends indicate increased use of contralateral prophylactic mastectomy (CPM) among newly diagnosed breast cancer patients, particularly those who test positive for a pathogenic variant in the BRCA1/2 genes. However, the rate of CPM among patients who test negative or choose not to be tested is surprisingly high. We aimed to identify patient predictors of CPM following breast cancer diagnosis among such patients. METHODS: As part of a randomized controlled trial of rapid genetic counseling and testing vs. usual care, breast cancer patients completed a baseline survey within 6 weeks of diagnosis and before definitive surgery. Analyses focused on patients who opted against testing (n = 136) or who received negative BRCA1/2 test results (n = 149). We used multivariable logistic regression to assess the associations between sociodemographic, clinical- and patient-reported factors with use of CPM. RESULTS: Among patients who were untested or who received negative test results, having discussed CPM with one's surgeon at the time of diagnosis predicted subsequent CPM. Patients who were not candidates for breast-conserving surgery and those with higher levels of cancer-specific intrusive thoughts were also more likely to obtain a CPM. CONCLUSION: The strongest predictors of CPM in this population were objective clinical factors and discussion with providers. However, baseline psychosocial factors were also independently related to the receipt of CPM. Thus, although CPM decisions are largely guided by relevant clinical factors, it is important to attend to psychosocial factors when counseling newly diagnosed breast cancer patients about treatment options.

The Collaborative Research Center for American Indian Health's Partnership River of Life: Special Issue Introduction.

In 2012, the National Institutes of Health funded the Collaborative Research Center for American Indian Health (CRCAIH) to work toward two broad goals: 1) to build tribal research infrastructure, and 2) to increase research on social determinants of health in American Indian communities. As the introduction to this special issue of American Indian and Alaska Native Mental Health Research, we highlight results from the Partnership River of Life evaluation tool in order to provide broader context for the other manuscripts presented here. Insights were gained during the Partnership River of Life group discussion and evaluation process of combining the groups' rivers to create one representation of the CRCAIH partnership. Detailed results underscore insights for similar transdisciplinary groups.

A Transdisciplinary Approach is Essential to Community-based Research with American Indian Populations.

Social determinants of health and their effects on health outcomes create a complex system, with interaction between social, economic, physical, and biological factors necessitating research take a holistic approach. Transdisciplinary research, one of the three core values of the Collaborative Research Center for American Indian Health, seeks to go beyond methods of knowledge production occurring solely within disciplinary boundaries, because real-world societal problems do not adhere to such restrictions. Community involvement is an essential component for successful research partnerships with American Indian and Alaska Native (AI/AN) communities. We posit that transdisciplinary approaches, which considers community-level expertise as an equitable component on the research team, show great potential for advancing research in AI/AN communities.

Not a One-Size-Fits-All Approach: Building Tribal Infrastructure for Research Through CRCAIH.

The Collaborative Research Center for American Indian Health (CRCAIH) was created to foster tribal partnerships in the Minnesota, North Dakota, and South Dakota regions to increase capacity for tribal research. Since 2013, through community engagement and technical assistance from CRCAIH's cores and divisions, seven tribal partners have expanded research infrastructure and recognize the benefits of an established tribal research office. This manuscript showcases the unique approaches individual CRCAIH tribal partners have taken to build tribal research infrastructure. The unique experiences of the CRCAIH tribal partnership holds valuable lessons for other tribes interested in increasing research capacity through research review, regulation, and data management.

Randomized trial of proactive rapid genetic counseling versus usual care for newly diagnosed breast cancer patients.

PURPOSE: Breast cancer patients who carry BRCA1/BRCA2 gene mutations may consider bilateral mastectomy. Having bilateral mastectomy at the time of diagnosis not only reduces risk of a contralateral breast cancer, but can eliminate the need for radiation therapy and yield improved reconstruction options. However, most patients do not receive genetic counseling or testing at the time of their diagnosis. In this trial, we tested proactive rapid genetic counseling and testing (RGCT) in newly diagnosed breast cancer patients in order to facilitate pre-surgical genetic counseling and testing. METHODS: We recruited newly diagnosed breast cancer patients at increased risk for carrying a BRCA1/2 mutation. Of 379 eligible patients who completed a baseline survey, 330 agreed to randomization in a 2:1 ratio to RGCT (n = 220) versus UC (n = 108). Primary outcomes were genetic counseling and testing uptake and breast cancer surgical decisions. RESULTS: RGCT led to higher overall (83.8% vs. 54.6%; p < 0.0001) and pre-surgical (57.8% vs. 38.7%; p = 0.001) genetic counseling uptake compared to UC. Despite higher rates of genetic counseling, RGCT did not differ from UC in overall (54.1% vs. 49.1%, p > 0.10) or pre-surgical (30.6% vs. 27.4%, p > 0.10) receipt of genetic test results nor did they differ in uptake of bilateral mastectomy (26.6% vs. 21.8%, p > 0.10). CONCLUSIONS: Although RGCT yielded increased genetic counseling participation, this did not result in increased rates of pre-surgical genetic testing or impact surgical decisions. These data suggest that those patients most likely to opt for genetic testing at the time of diagnosis are being effectively identified by their surgeons.

Development of a Pilot Grants Program in Social Determinants of Health in American Indian Health: A Program for Increasing the Representation of Underrepresented Groups in Funded Research.

The problem statement for this manuscript is to describe the literature on grant funding for underrepresented investigators, particularly American Indians, and detail the CRCAIH Pilot Grant Program and its success in developing underrepresented researchers (e.g. American Indian, early stage investigators). Grant funding is increasingly difficult to receive and the demographics of NIH grant awardees have shifted in recent decades to funding investigators that are more experienced. Additionally, racial disparities in awardees exist, particularly among American Indian (AI) researchers. Pilot grant funding mechanisms can be used by early stage investigators to collect preliminary data, which is beneficial for applying for NIH grants. The Collaborative Research Center for American Indian Health (CRCAIH) Pilot Grant Program (PGP) was aimed to increase research on the topic of social determinants of health in AI population health. Since there are no existing procedures for creating a PGP, CRCAIH created a PGP, and the processes are detailed here. Over four years, the CRCAIH PGP funded 15 projects with 47% of PIs or Co-PIs self-reporting as AI. Future directions for the CRCAIH PGP, including a mentoring program to provide more guidance and capacity building to the investigators, are also detailed.

Randomized Noninferiority Trial of Telephone vs In-Person Genetic Counseling for Hereditary Breast and Ovarian Cancer: A 12-Month Follow-Up.

BACKGROUND: Telephone delivery of genetic counseling is an alternative to in-person genetic counseling because it may extend the reach of genetic counseling. Previous reports have established the noninferiority of telephone counseling on short-term psychosocial and decision-making outcomes. Here we examine the long-term impact of telephone counseling (TC) vs in-person counseling (usual care [UC]). METHODS: We recruited high-risk women for a noninferiority trial comparing TC with UC. Of 1057 potentially eligible women, 669 were randomly assigned to TC (n = 335) or UC (n = 334), and 512 completed the 12-month follow-up. Primary outcomes were patient-reported satisfaction with genetic testing decision, distress, and quality of life. Secondary outcomes were uptake of cancer risk management strategies. RESULTS: TC was noninferior to UC on all primary outcomes. Satisfaction with decision (d = 0.13, lower bound of 97.5% confidence interval [CI] = -0.34) did not cross its one-point noninferiority limit, cancer-specific distress (d = -2.10, upper bound of 97.5% CI = -0.07) did not cross its four-point noninferiority limit, and genetic testing distress (d = -0.27, upper bound of 97.5% CI = 1.46), physical function (d = 0.44, lower bound of 97.5% CI = -0.91) and mental function (d = -0.04, lower bound of 97.5% CI = -1.44) did not cross their 2.5-point noninferiority limit. Bivariate analyses showed no differences in risk-reducing mastectomy or oophorectomy across groups; however, when combined, TC had significantly more risk-reducing surgeries than UC (17.8% vs 10.5%; χ2 = 4.43, P = .04). CONCLUSIONS: Findings support telephone delivery of genetic counseling to extend the accessibility of this service without long-term adverse outcomes.

Patient and genetic counselor perceptions of in-person versus telephone genetic counseling for hereditary breast/ovarian cancer.

Telephone genetic counseling (TC) for high-risk women interested in BRCA1/2 testing has been shown to yield positive outcomes comparable to usual care (UC; in-person) genetic counseling. However, little is known about how genetic counselors perceive the delivery of these alternate forms of genetic counseling. As part of a randomized trial of TC versus UC, genetic counselors completed a 5-item genetic counselor process questionnaire (GCQ) assessing key elements of pre-test sessions (information delivery, emotional support, addressing questions and concerns, tailoring of session, and facilitation of decision-making) with the 479 female participants (TC, N = 236; UC, N = 243). The GCQ scores did not differ for TC vs. UC sessions (t (477) = 0.11, p = 0.910). However, multivariate analysis showed that participant race/ethnicity significantly predicted genetic counselor perceptions (ß = 0.172, p < 0.001) in that the GCQ scores were lower for minorities in TC and UC. Exploratory analyses suggested that GCQ scores may be associated with patient preference for UC versus TC (t (79) = 2.21, p = 0.030). Additionally, we found that genetic counselor ratings of session effectiveness were generally concordant with patient perceptions of the session. These data indicate that genetic counselors perceive that key components of TC can be delivered as effectively as UC, and that these elements may contribute to specific aspects of patient satisfaction. However, undefined process differences may be present which account for lower counselor perceptions about the effectiveness of their sessions with minority women (i.e., those other than non-Hispanic Whites). We discuss other potential clinical and research implications of our findings.