Testing a Culturally Adapted Telephone Genetic Counseling Intervention
Condition: Breast Cancer; Hereditary Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      Participating in genetic cancer risk assessments (GCRA) for hereditary breast and ovarian
      cancer (HBOC) can inform treatment and risk management decisions and improve breast cancer
      outcomes. However, Latina women underuse GCRA services, which may increase breast cancer
      disparities. This study will adapt and test the impact of a Culturally Adapted Telephone
      Genetic Counseling Intervention to enhance the use and quality of genetic counseling services
      for underserved Latina women at-risk of hereditary breast and ovarian cancer
    

Detailed description: 
      SPECIFIC AIMS Women with BRCA1/2 mutations have a 50-80% and 15-40% lifetime risk of
      developing breast and ovarian cancer, respectively.1 Breast cancer survivors with BRCA1/2
      mutations are three times more likely to develop contralateral breast cancer than
      non-carriers.2 The National Comprehensive Cancer Network (NCCN) recommends referral for
      hereditary breast and ovarian cancer (HBOC) genetic cancer risk assessments (genetic
      counseling and consideration of genetic testing; GCRA) for women at high risk of carrying a
      mutation.3 A positive genetic test can inform treatment in newly diagnosed breast cancer
      patients and management in survivors and unaffected women.4 Latinas have a significantly
      higher BRCA1/2 gene mutation prevalence than non-Latina Whites,5 yet they are 4-5 times less
      likely to have GCRA.6 Reasons for lower GCRA use include access, language barriers, and
      psychosocial factors.7-12 Fewer than 5% of the already limited number of genetic counselors
      in the US speak a language other than English.13 Developing alternative strategies to enhance
      GCRA access is important to ensure national guidelines are met and to reduce disparities.5,14

      Our preliminary data suggest that GCRA referral guidelines are not consistently met among
      high-risk Latinas, many of whom are often not offered GCRA or are offered testing without
      counseling due to access and language barriers. Alternative strategies for delivery of
      genetic services, such as telephone genetic counseling (TGC), are safe, acceptable, and
      effective in both urban and rural populations.15,16 TGC can be a viable alternative strategy
      to in-person counseling for Latinas given that (1) TGC can enhance access to comprehensive
      genetic counseling by reducing cost and logistic barriers, which are especially important in
      underserved groups17; (2) TGC can also maximize the reach and access to the few
      Spanish-speaking genetic counselors in the US.13 Our initial data indicate that providers
      will increase the number of referrals to GCRA if Spanish genetic counseling is available.
      Thus, by overcoming access and language barriers, Spanish TGC can increase GCRA access among
      this high-risk yet underserved population.

      Beyond addressing access and language barriers, Spanish TGC may enhance the quality of
      information conveyed during counseling. Given the shortage of Spanish-speaking genetics
      professionals, English-speaking counselors use phone or in-person interpretation services
      with Spanish-speaking patients. Unfortunately, the quality of the information conveyed via
      Spanish interpreters is suboptimal.18 Interpreters do not have the requisite genetics
      expertise and may reduce, omit, or revise content.19 An initial study found that during HBOC
      genetic counseling, interpreters translated probabilistic statements as definitive or
      shortened and altered key explanations of risk information.18 In addition to potential
      content inaccuracies, interpretation typically precludes 'small talk' that helps build
      rapport.20 Our preliminary data align, suggesting both Latinas and providers report concerns
      about accuracy and rapport in sessions with interpreters. Spanish TGC could improve
      counseling quality by eliminating the need for interpretation for Latinas who are referred to
      and attend counseling.

      The investigators will compare evidence-based TCG developed by members of my mentoring
      team16,21 to usual care (UC) among high-risk, Spanish-speaking Latinas. The investigators
      anticipate that usual care will consist of either no referral to GCRA, offer of direct
      genetic testing without counseling, or genetic counseling with interpretation. Guided by the
      Ottawa Framework for Informed Decision Making22 the investigators propose a two phased mixed
      methods study. In Phase I, the investigators will conduct interviews with high-risk Latinas
      (n=15) to adapt the intervention materials using the Learner Verification and Revision
      frame.23 In Phase II, the investigators will use a cluster randomized design with four sites
      randomized to Spanish TGC (n=2 sites) or UC (n=2 sites). Our primary outcome is genetic
      counseling uptake among 60 high risk Latinas. Genetic testing uptake will be a secondary
      outcome. Among women who receive genetic counseling either through TGC or with an
      interpreter, the investigators will assess counseling quality by evaluating women's
      knowledge, counseling satisfaction, and communication in 20 audiotaped sessions. The
      investigators will assess communication using the gold standard RIAS quantitative coding
      system 24 and qualitative discourse analysis.25 Participants will complete assessments at
      baseline, post-counseling, and at 3 months. The investigators aim to:

      Aim 1. Culturally adapt the TGC booklet and genetic counseling protocols. Aim 2. Evaluate the
      impact of TGC vs. UC on GCRA access. Participants randomized to TGC (vs. UC) will have H.2.1.
      higher genetic counseling uptake H.2.2. higher testing uptake 3 months post intervention.

      Aim 3. Assess the quality of genetic counseling sessions among participants who attend the
      sessions. H.3.1. Participants randomized to TGC (vs. UC) will have higher HBOC knowledge and
      satisfaction and lower decisional conflict and distress. H.3.2. The investigators will
      explore communication patterns in 20 TGC and genetic counseling sessions with an interpreter
      using quantitative and qualitative methods.

      Given access barriers and the shortage of Spanish speaking genetic counselors, adapting and
      translating TGC intervention is a promising strategy that could reduce disparities by
      broadening the reach and accessibility to genetic counseling while enhancing the quality of
      the service.
    

Intervention name(s): Telephone Genetic Counseling
Intervention type(s): Behavioral
Intervention description(s): A genetic counselor fluent in Spanish (see letter of support) will conduct the TGC. The TGC intervention consists of two sessions. Prior to the sessions the investigators will mail participants the education materials with information to be reviewed prior to the genetic counseling session and a set of visual aids that the counselor will refer to during the session to facilitate the understanding of the information conveyed in the session.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The investigators will conduct a two-arm Randomized Controlled Trial (RCT) comparing Telephone Genetic Counseling in Spanish vs. Usual care.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Latinas; Survivors