- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03511690
Testing an Intelligent Tutoring System to Enhance Genetic Risk Assessment
Testing an Intelligent Tutoring System Intervention to Enhance Genetic Risk Assessment in Underserved Blacks and Latinas at Risk of Hereditary Breast Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Specific Aims BRCA1/2 mutations are the most commonly identified Hereditary Breast and Ovarian Cancer (HBOC) mutations. Women with these mutations have a 50-80% lifetime risk of developing breast cancer. Breast cancer survivors with a BRCA1/2 mutation are at a higher risk of developing contralateral breast cancer than survivors without mutations. The National Comprehensive Cancer Network (NCCN) recommends referral for HBOC genetic cancer risk assessments (genetic counseling and consideration of genetic testing for a single gene or panel testing; GCRA) for women at high risk for carrying a mutation. Obtaining a positive test can inform treatment in newly diagnosed breast cancer patients and management in survivors and unaffected women. Unfortunately, Latina and Black women have lower GCRA use than non-Latina Whites. Reasons for lower GCRA use include access and psychosocial factors (e.g. low knowledge, medical mistrust, low health literacy, anticipated negative emotions). There have been few GCRA interventions in ethnic minorities; two recent efforts largely focused on improving access, awareness, and knowledge with mixed success of impacting uptake. Theoretically guided interventions that support GCRA uptake in underserved populations are needed. Intervention development is particularly important given the growing complexity of multiplex gene testing and the potential to identify founder mutations or large rearrangements that are more prevalent in specific ethnic groups.
Our preliminary data with at-risk Black and Latina women suggests that improving access does not necessarily translate into higher GCRA uptake and that providers face challenges in communicating HBOC risk information. Patients have difficulty understanding HBOC numerical risk information, especially populations with low health literacy. Additionally, many existing educational tools were not theoretically derived, tend to prioritize quantitative risk communication, and do not often consider emotional aspects, despite evidence that emotions influence risk perceptions. Fuzzy Trace Theory posits that rather than relying on factual knowledge and quantitative risk comprehension, people construct gist representations that are anchored on culture and capture the essential bottom-line meaning of risk information, including the emotional experience. Informed by Fuzzy Trace Theory, BRCA-gist is an innovative Intelligent Tutoring System intervention that uses avatars to emulate tailored one-to-one human tutoring and includes the bottom-line meaning of risk messages. The preliminary efficacy of BRCA-gist was established in an experimental laboratory setting with mostly non-Hispanic White college students. Adapting BRCA-gist for a clinical sample of ethnically/racially diverse women at increased risk of carrying a mutation is important. Thus, BRCA-gist constitutes a scalable, inexpensive intervention with promising translational applications and potential to reduce disparities.
The goal of this mixed methods study is to adapt BRCA-gist and test the feasibility, acceptability, and efficacy of this innovative intervention in a sample of Black and Latina women at risk of HBOC (based on NCCN criteria using personal and family history of cancer). Using the Learner Verification and Revision framework, in Aim 1 we will gather input from site staff and community providers (n=10) about adaptations for implementation in clinical settings and from at-risk Latina and Black women (n=20) about cultural adaptations. In Aim 2 we will test the feasibility, acceptability, and efficacy of the adapted BRCA-gist on uptake of GCRA services. We will recruit 50 women nationally. After completing a brief baseline survey, we will randomize participants to an immediate intervention arm or a delayed arm. Women will complete a baseline survey and a two-week follow up survey. Primary outcomes include change in knowledge, attitudes, and intention about GCRA from baseline to follow-up
Aim 1: Adapt BRCA-gist. Providers and at-risk Black and Latina women will do the BRCA-gist intervention and provide feedback and suggestions to make cultural adaptations to implement BRCA-gist in community/clinic settings.
Aim 2: Test the feasibility, acceptability, and efficacy of BRCA-gist intervention in a delayed intervention trial.
H.2.1. We expect high overall retention (≥75%). H.2.2. We expect high satisfaction among women in the BRCA-gist arm (≥75%). H.2.3. Participants will have a greater increase in knowledge, gist comprehension, and intentions to use GCRA after attending to BRCA-Gist compared to the delayed arm.
H.2.4. Participants will have a higher uptake of GCRA services 2 weeks after they attend to BRCA-Gist compared to the delayed arm.
This project builds on our interdisciplinary teams' expertise in using innovative technologies to improve risk communication, disparities, translational genomics, cancer control interventions, and emotions. If successful, BRCA-gist can be tested in larger samples and could easily be disseminated into clinical settings and community clinics that serve underserved populations at increased risk for cancer.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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District of Columbia
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Washington, District of Columbia, United States, 20007
- Georgetown University
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Washington, District of Columbia, United States, 20003
- Capital Breast Care Center
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Virginia
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Alexandria, Virginia, United States, 22314
- Nueva Vida
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Richmond, Virginia, United States, 23284
- Virginia Commonwealth University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Self-identify as Black and/or Latina
- English proficiency
- Be 18 years old or older
- Be able to provide informed consent
- Be at risk of carrying HBOC mutation using personal/family cancer histories based on the NCCN guidelines
Exclusion Criteria:
- Prior participation in genetic counseling or genetic testing for hereditary cancer risk.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SCREENING
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Immediate BRCA-Gist Intervention
Participants randomized to immediate BRCA-gist will complete the adapted intervention and immediately complete a baseline survey.
They will be asked to complete a second survey two weeks after completion of the first one.
BRCA-gist is a web-based tutoring system that emulates one-to-one human tutoring via avatars to communicate risk of BRCA1/2.
We estimate a completion time of 90 minutes.
|
BRCA-gist is an innovative Intelligent Tutoring System intervention that uses avatars to emulate tailored one-to-one human tutoring and includes the bottom-line meaning of risk messages.
BRCA-gist is designed to provide the same information contained in four modules from the NCI webpages: "breast cancer and metastasis," "risk factors," "genetic mutation testing," and "the consequences of testing.
|
EXPERIMENTAL: Delayed BRCA-Gist Intervention
Participants randomized to delayed BRCA-gist will initially complete a baseline survey.
Two weeks after completion of that survey, they will complete the adapted intervention and immediately complete a second survey.
|
BRCA-gist is an innovative Intelligent Tutoring System intervention that uses avatars to emulate tailored one-to-one human tutoring and includes the bottom-line meaning of risk messages.
BRCA-gist is designed to provide the same information contained in four modules from the NCI webpages: "breast cancer and metastasis," "risk factors," "genetic mutation testing," and "the consequences of testing.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Breast Cancer Genetics Knowledge
Time Frame: Aim 2. From baseline to two week after the baseline.
|
Breast cancer genetics knowledge will be assessed with 13-items from Erblich and colleagues' scale where participants evaluate whether statements about breast cancer genetics are true or false.
The numbers of correct responses are added to create a score ranging from 0-13.
Higher scores mean higher breast cancer genetics knowledge.
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Aim 2. From baseline to two week after the baseline.
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Intentions to participate in genetic counseling
Time Frame: Aim 2. From baseline to two week after the baseline.
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Intentions to participate in genetic councSussner, Jandorf, Thompson, and Valdimarsdottir, 2010)
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Aim 2. From baseline to two week after the baseline.
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Perceived pros and cons of genetic counseling and testing
Time Frame: Aim 2. From baseline to two week after the baseline.
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Perceived pros and cons of genetic counseling and testing will be measured with a13-item 5-response Likert-type scale from Thompson and colleagues (2000) where participants rate their degree of agreement with statements about the potential benefits (7 items) and concerns of undergoing GCT (5 items).
The cons items are reverse coded.
Items are summed.
Higher score means higher perceived positive attitudes.
Scores range from 13-65.
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Aim 2. From baseline to two week after the baseline.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Uptake of Genetic Counseling
Time Frame: Two weeks after the intervention
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Scale
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Two weeks after the intervention
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Self-efficacy about participating in genetic counseling
Time Frame: within one hour before the intervention and within one hour post-intervention
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Self-efficacy about participating in genetic counseling will be measured with the Genetic Testing and Counseling Self-efficacy Scale (Hendy, Lyons, Breakwell, 2006).
The scale includes 3 items on a 5-point Likert-type response scale ranging from "completely agree" to "completely disagree."
Items are summed.
Scores range from 3-15.
Higher scores indicate higher self-efficacy in participating in counseling and testing.
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within one hour before the intervention and within one hour post-intervention
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Emotions about developing breast cancer and about participating in genetic counseling
Time Frame: within one hour before the intervention and within one hour post-intervention
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Emotion about participating in genetic counseling will be assessed with Andersen's (2003) 5 item scale that captures scale to assess individuals' worry about developing breast cancer and with Caballero's (2007) scale scale to measure anticipatory emotions (how participants feel right now about participating in GCRA services in the future).
Participants will report whether they feel positive (e.g.
relief) and negative anticipatory emotions (e.g.
worry) (Yes/No) and the level of intensity on a 7-point Likert-scale
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within one hour before the intervention and within one hour post-intervention
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Health Literacy and Numeracy
Time Frame: within one hour before the intervention
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General health literacy and numeracy with the Test of Functional Health Literacy in Adults (S-TOFHLA) short version that includes four numeracy items and two prose passages (Baker et al., 1999).
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within one hour before the intervention
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Mistrust about the medical system
Time Frame: within one hour before the intervention
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Mistrust about the medical system will be measured with the 7-item Medical Mistrust Index (Laveist et al., 2009)
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within one hour before the intervention
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Declarative Knowledge of Breast Cancer, Genetic Testing, and Genetic Risk
Time Frame: within one hour before the intervention and within one hour post-intervention
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Declarative Knowledge of Breast Cancer, Genetic Testing, and Genetic Risk - This scale developed by Wolfe and colleagues (2014) includes 52 four-alternative multiple-choice items about knowledge about breast cancer, genetic risk, and genetic testing.
The percentage of correct answers are calculated.
Higher percentages mean higher knowledge
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within one hour before the intervention and within one hour post-intervention
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Gist Comprehension of Genetic Cancer Risk
Time Frame: within one hour before the intervention and within one hour post-intervention
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Gist Comprehension of Genetic Cancer Risk (30 items).
We will measure Gist Comprehension of Genetic Cancer Risk with a scale developed by Wolfe et al (2014).
This 30-item Likert-type scale assesses gist comprehension of key information on breast cancer and genetic testing.
The scale ranges from 1-7 (ranging from strongly disagree to strongly agree with correct responses).
Responses are averaged.
Higher scores indicate higher gist comprehension.
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within one hour before the intervention and within one hour post-intervention
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Armstrong K, Micco E, Carney A, Stopfer J, Putt M. Racial differences in the use of BRCA1/2 testing among women with a family history of breast or ovarian cancer. JAMA. 2005 Apr 13;293(14):1729-36. doi: 10.1001/jama.293.14.1729.
- Easton DF. How many more breast cancer predisposition genes are there? Breast Cancer Res. 1999;1(1):14-7. doi: 10.1186/bcr6. Epub 1999 Aug 23. No abstract available.
- Chen S, Parmigiani G. Meta-analysis of BRCA1 and BRCA2 penetrance. J Clin Oncol. 2007 Apr 10;25(11):1329-33. doi: 10.1200/JCO.2006.09.1066.
- Malone KE, Begg CB, Haile RW, Borg A, Concannon P, Tellhed L, Xue S, Teraoka S, Bernstein L, Capanu M, Reiner AS, Riedel ER, Thomas DC, Mellemkjaer L, Lynch CF, Boice JD Jr, Anton-Culver H, Bernstein JL. Population-based study of the risk of second primary contralateral breast cancer associated with carrying a mutation in BRCA1 or BRCA2. J Clin Oncol. 2010 May 10;28(14):2404-10. doi: 10.1200/JCO.2009.24.2495. Epub 2010 Apr 5.
- Kauff ND, Satagopan JM, Robson ME, Scheuer L, Hensley M, Hudis CA, Ellis NA, Boyd J, Borgen PI, Barakat RR, Norton L, Castiel M, Nafa K, Offit K. Risk-reducing salpingo-oophorectomy in women with a BRCA1 or BRCA2 mutation. N Engl J Med. 2002 May 23;346(21):1609-15. doi: 10.1056/NEJMoa020119. Epub 2002 May 20.
- Levy DE, Byfield SD, Comstock CB, Garber JE, Syngal S, Crown WH, Shields AE. Underutilization of BRCA1/2 testing to guide breast cancer treatment: black and Hispanic women particularly at risk. Genet Med. 2011 Apr;13(4):349-55. doi: 10.1097/GIM.0b013e3182091ba4.
- Glenn BA, Chawla N, Bastani R. Barriers to genetic testing for breast cancer risk among ethnic minority women: an exploratory study. Ethn Dis. 2012 Summer;22(3):267-73.
- Sussner KM, Jandorf L, Thompson HS, Valdimarsdottir HB. Barriers and facilitators to BRCA genetic counseling among at-risk Latinas in New York City. Psychooncology. 2013 Jul;22(7):1594-604. doi: 10.1002/pon.3187. Epub 2012 Sep 16.
- Sussner KM, Edwards T, Villagra C, Rodriguez MC, Thompson HS, Jandorf L, Valdimarsdottir HB. BRCA genetic counseling among at-risk Latinas in New York City: new beliefs shape new generation. J Genet Couns. 2015 Feb;24(1):134-48. doi: 10.1007/s10897-014-9746-z. Epub 2014 Aug 15.
- Thompson HS, Valdimarsdottir HB, Jandorf L, Redd W. Perceived disadvantages and concerns about abuses of genetic testing for cancer risk: differences across African American, Latina and Caucasian women. Patient Educ Couns. 2003 Nov;51(3):217-27. doi: 10.1016/s0738-3991(02)00219-7.
- Mays D, Sharff ME, DeMarco TA, Williams B, Beck B, Sheppard VB, Peshkin BN, Eng-Wong J, Tercyak KP. Outcomes of a systems-level intervention offering breast cancer risk assessments to low-income underserved women. Fam Cancer. 2012 Sep;11(3):493-502. doi: 10.1007/s10689-012-9541-7.
- Ricker C, Lagos V, Feldman N, Hiyama S, Fuentes S, Kumar V, Gonzalez K, Palomares M, Blazer K, Lowstuter K, MacDonald D, Weitzel J. If we build it ... will they come?--establishing a cancer genetics services clinic for an underserved predominantly Latina cohort. J Genet Couns. 2006 Dec;15(6):505-14. doi: 10.1007/s10897-006-9052-5.
- Hall MJ, Olopade OI. Disparities in genetic testing: thinking outside the BRCA box. J Clin Oncol. 2006 May 10;24(14):2197-203. doi: 10.1200/JCO.2006.05.5889.
- Weitzel JN, Clague J, Martir-Negron A, Ogaz R, Herzog J, Ricker C, Jungbluth C, Cina C, Duncan P, Unzeitig G, Saldivar JS, Beattie M, Feldman N, Sand S, Port D, Barragan DI, John EM, Neuhausen SL, Larson GP. Prevalence and type of BRCA mutations in Hispanics undergoing genetic cancer risk assessment in the southwestern United States: a report from the Clinical Cancer Genetics Community Research Network. J Clin Oncol. 2013 Jan 10;31(2):210-6. doi: 10.1200/JCO.2011.41.0027. Epub 2012 Dec 10. Erratum In: J Clin Oncol. 2013 May 1;31(13):1702.
- Graves KD, Christopher J, Harrison TM, Peshkin BN, Isaacs C, Sheppard VB. Providers' perceptions and practices regarding BRCA1/2 genetic counseling and testing in African American women. J Genet Couns. 2011 Dec;20(6):674-89. doi: 10.1007/s10897-011-9396-3. Epub 2011 Aug 6.
- Wolfe CR, Reyna VF, Widmer CL, Cedillos EM, Fisher CR, Brust-Renck PG, Weil AM. Efficacy of a web-based intelligent tutoring system for communicating genetic risk of breast cancer: a fuzzy-trace theory approach. Med Decis Making. 2015 Jan;35(1):46-59. doi: 10.1177/0272989X14535983. Epub 2014 May 14.
- Zikmund-Fisher BJ, Fagerlin A, Ubel PA. Risky feelings: why a 6% risk of cancer does not always feel like 6%. Patient Educ Couns. 2010 Dec;81 Suppl:S87-93. doi: 10.1016/j.pec.2010.07.041. Epub 2010 Aug 23.
- Reyna VF, Nelson WL, Han PK, Pignone MP. Decision making and cancer. Am Psychol. 2015 Feb-Mar;70(2):105-18. doi: 10.1037/a0036834.
- Caballero A, Carrera P, Munoz D, Flor S. Emotional ambivalence in risk behaviors: the case of occasional excessive use of alcohol. Span J Psychol. 2007 May;10(1):151-8. doi: 10.1017/s1138741600006417.
- Baker DW, Williams MV, Parker RM, Gazmararian JA, Nurss J. Development of a brief test to measure functional health literacy. Patient Educ Couns. 1999 Sep;38(1):33-42. doi: 10.1016/s0738-3991(98)00116-5.
- Sheppard VB, Mays D, LaVeist T, Tercyak KP. Medical mistrust influences black women's level of engagement in BRCA 1/2 genetic counseling and testing. J Natl Med Assoc. 2013 Spring;105(1):17-22. doi: 10.1016/s0027-9684(15)30081-x.
- LaVeist TA, Isaac LA, Williams KP. Mistrust of health care organizations is associated with underutilization of health services. Health Serv Res. 2009 Dec;44(6):2093-105. doi: 10.1111/j.1475-6773.2009.01017.x. Epub 2009 Sep 2.
- Erblich J, Brown K, Kim Y, Valdimarsdottir HB, Livingston BE, Bovbjerg DH. Development and validation of a Breast Cancer Genetic Counseling Knowledge Questionnaire. Patient Educ Couns. 2005 Feb;56(2):182-91. doi: 10.1016/j.pec.2004.02.007.
- Hendy J, Lyons E, Breakwell GM. Genetic testing and the relationship between specific and general self-efficacy. Br J Health Psychol. 2006 May;11(Pt 2):221-33. doi: 10.1348/135910705X52543.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Breast Diseases
- Genetic Diseases, Inborn
- Neoplastic Syndromes, Hereditary
- Ovarian Neoplasms
- Breast Neoplasms
- Hereditary Breast and Ovarian Cancer Syndrome
Other Study ID Numbers
- 1R21NR016905-01A1 (NIH)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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