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.

Public Health Relevance

Genetic counseling for hereditary breast and ovarian cancer (HBOC) is underutilized, especially in Hispanic and rural women. The proposed Genetic Risk Assessment for Cancer Education and Empowerment (GRACE) Project is a 3-arm randomized trial that will 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 genetic counseling for HBOC in high-risk cancer survivors. If either or both of our interventions prove successful, they can be broadly disseminated to improve cancer outcomes and reduce health disparities.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
5R01CA211625-05
Application #
10053322
Study Section
Societal and Ethical Issues in Research Study Section (SEIR)
Program Officer
Breslau, Erica S
Project Start
2016-12-22
Project End
2021-11-30
Budget Start
2020-12-01
Budget End
2021-11-30
Support Year
5
Fiscal Year
2021
Total Cost
Indirect Cost
Name
Rbhs -Cancer Institute of New Jersey
Department
Type
Overall Medical
DUNS #
078728091
City
New Brunswick
State
NJ
Country
United States
Zip Code
08901