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Testing an Intelligent Tutoring System to Enhance Genetic Risk Assessment

Sponsor
Georgetown University (Other)
Overall Status
Completed
CT.gov ID
NCT03511690
Collaborator
Virginia Commonwealth University (Other), Cornell University (Other)
95
Enrollment
4
Locations
2
Arms
55.7
Actual Duration (Months)
23.8
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Participating in genetic cancer risk assessments (GCRA) for hereditary breast and ovarian cancer can inform treatment and risk management decisions and improve breast cancer outcomes. However, Latina and Black women underuse GCRA services, which may increase breast cancer disparities. This study will adapt and test the impact of an easily scalable novel Tutoring System intervention to enhance GCRA use and improve psychosocial outcomes in a clinical sample of underserved Latina and Black women at risk of hereditary breast and ovarian cancer.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: BRCA-Gist
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
95 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants are randomized to an immediate or delayed armParticipants are randomized to an immediate or delayed arm
Masking:
Single (Outcomes Assessor)
Masking Description:
Randomization schedules will be developed by the biostatistician and administered by an individual (staff) not involved in the study analyses so that the statistician will be blinded to the allocation. This method will ensure unbiased results.
Primary Purpose:
Screening
Official Title:
Testing an Intelligent Tutoring System Intervention to Enhance Genetic Risk Assessment in Underserved Blacks and Latinas at Risk of Hereditary Breast Cancer
Actual Study Start Date :
Jul 1, 2017
Actual Primary Completion Date :
Feb 20, 2022
Actual Study Completion Date :
Feb 20, 2022

Arms and Interventions

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.

Behavioral: BRCA-Gist
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.

Behavioral: BRCA-Gist
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.

Outcome Measures

Primary Outcome Measures

  1. Breast Cancer Genetics Knowledge [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.

  2. Intentions to participate in genetic counseling [Aim 2. From baseline to two week after the baseline.]

    Intentions to participate in genetic councSussner, Jandorf, Thompson, and Valdimarsdottir, 2010)

  3. Perceived pros and cons of genetic counseling and testing [Aim 2. From baseline to two week after the baseline.]

    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.

Secondary Outcome Measures

  1. Uptake of Genetic Counseling [Two weeks after the intervention]

    Scale

  2. Self-efficacy about participating in genetic counseling [within one hour before the intervention and within one hour post-intervention]

    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.

  3. Emotions about developing breast cancer and about participating in genetic counseling [within one hour before the intervention and within one hour post-intervention]

    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

  4. Health Literacy and Numeracy [within one hour before the intervention]

    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).

  5. Mistrust about the medical system [within one hour before the intervention]

    Mistrust about the medical system will be measured with the 7-item Medical Mistrust Index (Laveist et al., 2009)

  6. Declarative Knowledge of Breast Cancer, Genetic Testing, and Genetic Risk [within one hour before the intervention and within one hour post-intervention]

    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

  7. Gist Comprehension of Genetic Cancer Risk [within one hour before the intervention and within one hour post-intervention]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Capital Breast Care Center Washington District of Columbia United States 20003
2 Georgetown University Washington District of Columbia United States 20007
3 Nueva Vida Alexandria Virginia United States 22314
4 Virginia Commonwealth University Richmond Virginia United States 23284

Sponsors and Collaborators

  • Georgetown University
  • Virginia Commonwealth University
  • Cornell University

Investigators

  • Principal Investigator: Alejandra H Hurtado de Mendoza, PhD, Georgetown University
  • Principal Investigator: Vanessa Sheppard, PhD, Virginia Commonwealth University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Alejandra Hurtado de Mendoza, Assistant Professor, Georgetown University
ClinicalTrials.gov Identifier:
NCT03511690
Other Study ID Numbers:
  • 1R21NR016905-01A1
First Posted:
Apr 30, 2018
Last Update Posted:
Apr 25, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Alejandra Hurtado de Mendoza, Assistant Professor, Georgetown University
Latinas, African Americans
Additional relevant MeSH terms:
Hereditary Breast and Ovarian Cancer Syndrome

Study Results

No Results Posted as of Apr 25, 2022