Condition or disease | Intervention/treatment | Phase |
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Breast Cancer Hereditary Breast Cancer | Behavioral: Telephone Genetic Counseling | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 74 participants |
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 |
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 |
Actual Study Start Date : | July 7, 2017 |
Estimated Primary Completion Date : | October 2020 |
Estimated Study Completion Date : | December 2020 |
Arm | Intervention/treatment |
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No Intervention: Usual Care
Participants will continue with their usual medical care. Usual care may vary at different sites. Based on the investigator's preliminary data usual care can result in not GCRA referral, referral directly to testing, or referral to genetic counseling with an interpreter. The investigators will document usual care for participants from the sites randomized to usual care.
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Telephone Genetic Counseling
Participants will receive telephone genetic counseling with the culturally adapted protocol and booklet
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Behavioral: Telephone Genetic Counseling
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.
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Ages Eligible for Study: | 21 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | Based on the self-representation of gender identity |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Alejandra Hurtado de Mendoza, PhD | 2026878916 | ahd28@georgetown.edu | |
Contact: Sara Gómez Trillos, BA | 2026870806 | sg1328@georgetown.edu |
United States, District of Columbia | |
Capital Breast Care Center | Recruiting |
Washington, District of Columbia, United States, 20003 | |
Contact: Nathaly Gonzalez 202-784-2705 ng472@georgetown.edu | |
Contact: Lucille Adams-Campbell, PhD 202-687-5367 lla9@georgetown.edu | |
United States, New Jersey | |
Hackensack Meridian Health | Terminated |
Hackensack, New Jersey, United States, 07601 | |
United States, Virginia | |
Nueva Vida | Recruiting |
Alexandria, Virginia, United States, 22314 | |
Contact: Claudia Campos 202-223-9100 ccampos@nueva-vida.org | |
Contact: Astrid Jimenez 202-223-9100 executivedirector@nueva-vida.org | |
Virginia Commonwealth University | Recruiting |
Richmond, Virginia, United States, 23284 | |
Contact: Yvonne Cummings 804-828-0643 Yvonne.Cummings@vcuhealth.org | |
Contact: Vanessa Sheppard, PhD Vanessa.Sheppard@vcuhealth.org |
Principal Investigator: | Alejandra Hurtado de Mendoza, PhD | Georgetown University |
Tracking Information | |||||||||
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First Submitted Date ICMJE | May 8, 2019 | ||||||||
First Posted Date ICMJE | May 22, 2019 | ||||||||
Last Update Posted Date | June 11, 2020 | ||||||||
Actual Study Start Date ICMJE | July 7, 2017 | ||||||||
Estimated Primary Completion Date | October 2020 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Number of participants that receive genetic cancer risk assessment (GCRA) [ Time Frame: Three months after baseline ] The RA will conduct a follow-up call to inquire whether participants randomized to Usual Care completed a GCRA appointment and to gather information about the place where the appointment was held and name of the genetic counselor
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Same as current | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Testing a Culturally Adapted Telephone Genetic Counseling Intervention | ||||||||
Official Title ICMJE | Testing a Culturally Adapted Telephone Genetic Counseling Intervention to Enhance Genetic Risk Assessment in Underserved Latinas at Risk of Hereditary Breast and Ovarian Cancer | ||||||||
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. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | 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 |
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Condition ICMJE |
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Intervention ICMJE | Behavioral: Telephone Genetic Counseling
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.
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
74 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | December 2020 | ||||||||
Estimated Primary Completion Date | October 2020 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 21 Years to 90 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03959267 | ||||||||
Other Study ID Numbers ICMJE | KL2TR001432( U.S. NIH Grant/Contract ) | ||||||||
Has Data Monitoring Committee | Not Provided | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||||
Responsible Party | Alejandra Hurtado de Mendoza, Georgetown University | ||||||||
Study Sponsor ICMJE | Georgetown University | ||||||||
Collaborators ICMJE | Hackensack Meridian Health | ||||||||
Investigators ICMJE |
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PRS Account | Georgetown University | ||||||||
Verification Date | June 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |