Clinical trial NCT03959267: Testing a Culturally Adapted Telephone Genetic Counseling Intervention
Official title: Testing a Culturally Adapted Telephone Genetic Counseling Intervention to Enhance Genetic Risk Assessment in Underserved Latinas at Risk of Hereditary Breast and Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Hereditary Breast Cancer
Keywords: Latinas
Survivors
Lead sponsor: Georgetown University
Sponsor class: OTHER
Collaborators: name: Hackensack Meridian Health
First posted: 2019-05-22
Enrollment: 37
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators will conduct a two-arm Randomized Controlled Trial (RCT) comparing Telephone Genetic Counseling in Spanish vs. Usual care.
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Self-identify as Latina/Hispanic
* Be 21 years old or older
* Be at risk of hereditary breast and ovarian cancer because of personal and/or family medical history according to NCCN guidelines
* Be diagnosed with breast cancer, and have completed active treatment (i.e., chemotherapy, radiation, surgeries)
* Be able to provide the name and contact information of a primary healthcare provider, whom they see at least once a year
* Speak and read Spanish.

Exclusion Criteria:

* Do not identify as Latina/Hispanic.
* Younger than 21 years old.
* Do not meet current national guidelines to be considered at risk for hereditary breast and ovarian cancer.
* Has been diagnosed with ovarian cancer or stage IV breast cancer.
* Has not completed active treatment (e.g., surgery, chemotherapy, radiation).
* Is not able to provide the name and contact information of the primary healthcare provider. This must be someone whom they have seen at least once during the past 12 months.
* Cannot provide consent to participate.
* Has received genetic counseling by a genetics professional (e.g., genetic counselor or genetics nurse).
* Has participated in a previous phase of this study.
* Cannot provide a copy of their genetic test results.

Primary outcomes:
measure: Number of participants that receive genetic cancer risk assessment (GCRA)
timeFrame: Three months after baseline
Secondary outcomes:
measure: Change in knowledge
timeFrame: Change from baseline to three months after baseline
measure: Change in decisional conflict
timeFrame: Change from baseline to three months after baseline
measure: Distress
timeFrame: At baseline
measure: Decision Satisfaction
timeFrame: Three months after baseline
measure: Satisfaction with counseling
timeFrame: Three months after baseline
measure: Number of participants that receive genetic testing
timeFrame: Three months after baseline
Other outcomes:
measure: Communication
timeFrame: Three months after baseline
measure: Communication
timeFrame: Three months after baseline
measure: Acceptability
timeFrame: Thee months after baseline
Locations:
city: Washington
country: United States
facility: Capital Breast Care Center
state: District of Columbia
city: Hackensack
country: United States
facility: Hackensack Meridian Health
state: New Jersey
city: Alexandria
country: United States
facility: Nueva Vida
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Georgetown University
name: Alejandra Hurtado de Mendoza, PhD
role: PRINCIPAL_INVESTIGATOR
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