||7R01CA211625-03 Interpret this number
||Rbhs -Cancer Institute Of New Jersey
||Comparative Effectiveness of Interventions to Increase Guideline-Based Genetic Counseling in Ethnically and Geographically Diverse Cancer Survivors
Genetic counseling or Cancer Genetic Risk Assessment (CGRA) for hereditary breast and ovarian cancer
(HBOC) is an evidence-based precision medicine strategy that facilitates informed decision making about
effective health management options. Identification of individuals at increased risk of HBOC is crucial for
cancer survivors and their families to benefit from biomedical advances in cancer prevention, early detection,
treatment and survivorship. Although national guidelines for CGRA and genetic testing have been available for
two decades, only one-third or less of high-risk women have accessed these services. The optimal risk
assessment strategy starts with an individual with an HBOC-related cancer. Widespread dissemination and
adoption of national guidelines for informed decision-making and promoting CGRA is needed to achieve a
population-level reduction in cancer morbidity, mortality and disparities. Thus, it is important to promote access
to CGRA, particularly in medically underserved populations. The proposed Genetic Risk Assessment for
Cancer Education and Empowerment (GRACE) Project seeks to address this important translational gap by
developing and implementing strategies to promote guideline-based care in the Rocky Mountain region where
there are distinguishable disparities in CGRA utilization by ethnicity and geography. Remarkably, few
intervention studies have been conducted to address the regional and national translational gap in CGRA
utilization for these diverse populations, underscoring our study's high impact and innovative public health
intervention delivery approach. The GRACE Project is guided by evidenced-based behavior change counseling
strategies to promote risk-based care delivery and reduce disparities that consider individual, cultural, social
and system-level factors. The study's primary aim is to test the comparative effectiveness of mailed targeted
print (TP) vs. TP plus a telephone-based tailored counseling and navigation intervention (TCN) vs. usual care
(UC) to increase guideline-based CGRA for HBOC. We will oversample Hispanics and rural dwellers and enroll
1206 high-risk female cancer survivors. Women will be recruited through the Colorado and New Mexico cancer
registries and meet the criteria for a CGRA referral. Enrollees will be randomized to one of 3 study arms and
complete baseline, 1-month, 6-month and 12-month surveys. Specific aims are to: 1) compare the
effectiveness of a targeted intervention (TP) vs. a tailored (TPC) intervention vs. usual care (UC) on CGRA
utilization 6 months (primary outcome) after the intervention and at 12 months, after removal of key access
barriers; 2) compare the effectiveness of the interventions on genetic testing utilization; 3) examine potential
underlying theoretical mediating and moderating mechanisms that will further specify and elucidate significant
intervention effects; and 4) compare the cost effectiveness of the interventions vs. usual care, for utilization of
CGRA services. If effective, either or both interventions have the potential to reach a large number of high-risk
families and reduce disparities through broad dissemination.
Promoting guideline-based cancer genetic risk assessment for hereditary breast and ovarian cancer in ethnically and geographically diverse cancer survivors: Rationale and design of a 3-arm randomized controlled trial.
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, Valverde P.A.
, et al.
Contemporary Clinical Trials, 2018 Oct; 73, p. 123-135.