Improving Uptake of Genetic Cancer Risk Assessment in African American Women- Video
Condition: Breast Cancer
Study type: Interventional

Summary: 
      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 will conduct a RCT to test the efficacy of a
      culturally-tailored theory-based video intervention aimed to address key psychosocial factors
      (emotions, ambivalence) to improve 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 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 with 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 focused
      solely on knowledge or access, the proposed study makes a considerable shift in the field by
      additionally targeting emotions, ambivalence, and developing a media-based risk communication
      tool.

      Guided by two evidenced-based theories and preliminary data, this will be a two-phased mixed
      methods study. In Phase I (months 1-7), formative research and preliminary data will be used
      to develop the script for the GCT video. The script will be 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) will be conducted . All women will be referred to an appointment scheduler who will
      assist them with making an appointment with a genetic counselor. Participants will complete a
      baseline survey and follow-up assessment. The primary outcome will be genetic counseling
      uptake and receipt testing at 3-months will be explored. Specific aims are to:

      Aim 1. Develop a YouTube video using a 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. control group arm. H.2.1. Women in the intervention group (vs
      control group) will have higher genetic counseling uptake. H.2.2. Women in the intervention
      group (vs control group) will report higher knowledge, higher self-efficacy, higher
      endorsement of positive attitudes, and positive anticipated emotions about GCT. H.2.3. Most
      women (≥75%) will be satisfied with the experimental intervention.

      Enhancing GCT in at-risk populations is a national priority. Given trends towards panel
      testing and other genomic advances, there is potential for existing disparities to widen.
      Findings will 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 will inform new strategies for behavioral
      interventions targeting African-Americans in a larger trial.
    

Intervention name(s): YouTube Video Arm
Intervention type(s): Behavioral
Intervention description(s): Participants (n=25) will watch a 20 minute YouTube video that will describe the genetic counseling and testing process and risk/benefit information in a culturally relevant format. Participants will complete pre and post assessments. After the session, participants interested in pursuing genetic counseling and testing services will be referred to a patient navigator who will navigate participants to identified no cost or low cost services.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: genetic counseling and testing