Improving Uptake of Genetic Cancer Risk Assessment in African American Women- Video
Phase: NA
Conditions: Breast Cancer
Sponsor: Virginia Commonwealth University

Improving Uptake of Genetic Cancer Risk Assessment in African American Women - Video 
Title: Improving Uptake of Genetic Cancer Risk Assessment in African American Women – 
Video 
Protocol # NCI-2019-0489 
NCT# NCT 04476654 
Current IRB Approval Date 8.9.23 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Improving Uptake of Genetic Cancer Risk Assessment in African American Women - Video 
Study Overview 
Genetic counseling and testing (GCT) provides invaluable information for women who are at 
risk of hereditary breast and/or ovarian cancer (HBOC). Black women underutilize GCT 
compared to White women. This study conducted an RCT to test the efficacy of a culturally-
tailored theory-based video intervention aimed to address key psychosocial factors (emotions, 
ambivalence) to improve the uptake of genetic counseling in Black women at increased risk of 
HBOC. Findings from this study may offer an opportunity to engage at-risk Black women 
regarding genetic counseling through a multi-center trial and ultimately address the disparity in 
genetic counseling uptake that exists between Black and White women. 
 
Detailed Description 
Breast cancer (BC) is the most frequently diagnosed cancer in African American women 
(hereafter referred to as "Black"), and their cancer mortality is higher than other racial/ethnic 
groups in the United States (US). Compared to non-Hispanic Whites, Black women are 
diagnosed younger and with more advanced breast cancer. When diagnosed with BC, Black 
women present more often with triple-negative breast cancer (TNBC), an aggressive disease 
defined by the absence of estrogen and progesterone receptors and human epidermal growth 
factor (HER)-2 expression. TNBC has been associated with pathogenic BRCA1 variants. Racial 
disparities also exist for women with ovarian cancer, the most lethal of the gynecologic cancers. 
Among women with advanced ovarian cancers, up to 21% are associated with inherited 
pathogenic mutations, the most common of which is BRCA1. Women who carry a pathogenic 
BRCA variant (PV) have a lifetime breast cancer risk of 55-70% and a lifetime ovarian cancer 
risk of up to 44%. The National Comprehensive Cancer Network (NCCN) recommends referral 
for Hereditary Breast and Ovarian Cancer (HBOC) genetic counseling and testing (GCT) for 
women at risk of carrying a BRCA PV. GCT provides women with the information needed to 
make informed decisions to reduce their cancer risk, yet Black women are less likely to use GCT 
than Whites. There is a dearth of interventions to address this issue and produced results are 
mixed and modest. Awareness of a positive result can inform treatment decisions for cancer 
patients and risk management in survivors or women unaffected by cancer. 
Reasons for the lower uptake of GCT in Black women are multi-factorial and include access, 
knowledge, psycho-social factors, and may vary by cancer status (affected versus unaffected). 
There are substantial scientific gaps regarding effective interventions to address the sub-optimal 
uptake of GCT in Black women. To be effective, GCT interventions should be anchored within 
the needs and cultural values of their audience. While improving knowledge about GCT and 
one's individual risks is important, interventions that only address knowledge may not enhance 
uptake, as risk information evokes emotional reactions that are often stronger predictors of 
behaviors than cognitive factors. 
Notably, this team has identified factors that contribute to Black women's uptake of GCT. In 
preliminary studies, researchers found that self-efficacy in making decisions about GCT and 
medical mistrust were associated with GCT uptake. Low knowledge among Black BC survivors 
at risk of HBOC has also been found. Anticipated negative emotions to GCT have been 
associated with lower uptake. Similar studies suggest that Black women report emotions related 
to fear of being singled out and the fear of being hopeless. Because most interventions have 

Improving Uptake of Genetic Cancer Risk Assessment in African American Women - Video 
focused solely on knowledge or access, the proposed study makes a considerable shift in the field 
by additionally targeting emotions and ambivalence and developing a media-based risk 
communication tool. 
Guided by two evidenced-based theories and preliminary data, this was a two-phased mixed 
methods study. In Phase I (months 1-7), formative research and preliminary data were used to 
develop the script for the GCT video. The script was reviewed by GCT experts (n=4) and piloted 
in two focus groups (n=16), followed by a staged reading to make final refinements. In Phase II 
(months 8-24), a two-arm randomized trial (RCT) to compare GCT uptake and psycho-social 
outcomes between 50 at-risk Black women receiving printed Susan G. Komen developed GCT 
literature (control group) (n=25) or a tailored YouTube video intervention (n=25) was be 
conducted. All women were referred to an appointment scheduler who assisted them with 
making an appointment with a genetic counselor. Participants completed a baseline survey and 
follow-up assessment. The primary outcome was genetic counseling uptake, and receipt testing 
at 3 months was explored. Specific aims are to: 
Aim 1. Develop a YouTube video using formative data for Black women at risk for HBOC. 
Aim 2. Evaluate the efficacy of the intervention by comparing outcomes between women in the 
YouTube intervention arm vs. the control group arm. H.2.1. Women in the intervention group 
(vs. control group) had higher genetic counseling uptake. H.2.2. Women in the intervention 
group (vs. control group) was report higher knowledge, higher self-efficacy, higher endorsement 
of positive attitudes, and positive anticipated emotions about GCT. H.2.3. Most women (≥75%) 
were satisfied with the experimental intervention. 
Enhancing GCT in at-risk populations is a national priority. Given trends toward panel testing 
and other genomic advances, there is potential for existing disparities to widen. Findings inform 
new strategies for behavioral interventions for Black women and a larger trial. If successful, the 
intervention could be easily disseminated, broadening its reach to affected and unaffected 
women. 
This study meets the Healthy People 2020 goals to enhance GRCA in at-risk populations, and the 
national priorities to increase diversity in genetics research participation and incorporate 
emotions into cancer research. Findings informed new strategies for behavioral interventions 
targeting African Americans in a larger trial. 
Participation Criteria  
Inclusion Criteria: 
• 
Must be at least 18 years of age 
• 
Must be at high risk for hereditary breast or ovarian cancer 
• 
Must identify as Black/African American 
• 
Must be a woman 
• 
Referred to a genetic counselor for the purpose of being at high risk of carrying a 
hereditary breast and/or ovarian cancer mutation 

Improving Uptake of Genetic Cancer Risk Assessment in African American Women - Video 
Genetic Counselors: 
• 
Must be at least 18 years of age 
• 
Must be qualified 
• 
Must be approved by the PI 
Exclusion Criteria: 
• 
Under the age of 18 
• 
Race other than Black/African American 
• 
Do not have a high risk for hereditary breast or ovarian cancer 
Genetic Counselors: 
• 
Under 18 
• 
Not qualified 
• 
Not approved by the PI 
Participant Group/Arm  
Intervention/Treatment  
No Intervention: Fact Sheet 
Arm 
Komen print materials 
about genetic counseling 
and testing will be given to 
women. 
 
Active 
Comparator: YouTube 
Video Arm 
Participants in this arm was 
receive the culturally 
tailored video either via a 
YouTube link or a DVD. 
Behavioral: YouTube Video Arm 
• 
Participants (n=25) watched a 20-minute YouTube 
video that described the genetic counseling and 
testing process and risk/benefit information in a 
culturally relevant format. Participants completed 
pre and post-assessments. After the session, 
participants interested in pursuing genetic 
counseling and testing services were referred to a 
patient navigator who navigated participants to 
identify no-cost or low-cost services. 

Improving Uptake of Genetic Cancer Risk Assessment in African American Women - Video 
 
What is the study measuring? 
 
Outcome Measure 
Measure Description 
Rate of genetic counseling and testing uptake. 
Our primary outcome was for participants to 
receive genetic testing and counseling. 
Investigators were able to see if a participant 
had scheduled a genetic testing appointment 
within the VCU Health appointment system. 
 
 
Secondary Outcome Measures 
Outcome Measure 
Measure Description 
Time Frame 
Knowledge Scale - 
Genetic counseling and 
testing knowledge. 
The investigators tested 
general knowledge about 
hereditary breast and ovarian 
cancer 
Within one hour before 
the intervention and 
within one hour post-
intervention. 
Self-efficacy Scale 
The investigators tested self-
efficacy in genetic counseling 
services. 
Within one hour before 
the intervention and 
within one hour post-
intervention. 
Emotional Ambivalence 
Scale 
The investigators tested the 
emotional ambivalence about 
participating in genetic 
counseling services. 
Within one hour before 
the intervention and 
within one hour post-
intervention.