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Testing an Intelligent Tutoring System to Enhance Genetic Risk Assessment

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ClinicalTrials.gov Identifier: NCT03511690
Recruitment Status : Recruiting
First Posted : April 30, 2018
Last Update Posted : October 24, 2019
Sponsor:
Collaborator:
Virginia Commonwealth University
Information provided by (Responsible Party):
Alejandra Hurtado de Mendoza, Georgetown University

Tracking Information
First Submitted Date  ICMJE April 16, 2018
First Posted Date  ICMJE April 30, 2018
Last Update Posted Date October 24, 2019
Actual Study Start Date  ICMJE July 26, 2017
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2018)
Uptake of Genetic Counseling [ Time Frame: Three months post intervention ]
The RA will conduct a follow-up call three months post-intervention to inquire whether participants scheduled and/or completed a GCRA appointment and to gather information about the place where the appointment was held and name of the genetic counselor.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2018)
  • Breast Cancer Genetics Knowledge [ Time Frame: within one hour before the intervention and within one hour post-intervention ]
    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.
  • Intentions to participate in genetic counseling [ Time Frame: within one hour before the intervention and within one hour post-intervention ]
    Intentions to participate in genetic councSussner, Jandorf, Thompson, and Valdimarsdottir, 2010)
  • Perceived pros and cons of genetic counseling and testing Perceived pros and cons of genetic counseling and testing [ Time Frame: within one hour before the intervention and within one hour post-intervention ]
    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.
  • Self-efficacy about participating in genetic counseling [ Time Frame: 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.
  • 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 ]
    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
  • Health Literacy and Numeracy [ Time Frame: 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).
  • Mistrust about the medical system [ Time Frame: 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)
  • Declarative Knowledge of Breast Cancer, Genetic Testing, and Genetic Risk [ Time Frame: 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
  • Gist Comprehension of Genetic Cancer Risk [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2018)
  • Knowledge about hereditary breast and ovarian cancer [ Time Frame: within one hour before the intervention and within one hour post-intervention ]
    Knowledge about hereditary breast and ovarian cancer will be assessed with three scales. The Declarative Knowledge scale is a 52 item multiple choice scale that measures the knowledge about the facts included in the NCI webpage (Wolfe et al 2015). The gist comprehension scale is a 30 item Likert-type scale that measures gist comprehension of genetic cancer risk (Wolfe et al. 2015). We will also include one 13-item true/false scale Elbrich, 2005)
  • Intentions to participate in genetic counseling [ Time Frame: within one hour before the intervention and within one hour post-intervention ]
    Intentions to participate in genetic councSussner, Jandorf, Thompson, and Valdimarsdottir, 2010)
  • Attitudes about participating in genetic counseling [ Time Frame: within one hour before the intervention and within one hour post-intervention ]
    Attitudes about participating in genetic counseling will be measured with Thompson (2000) 13-item Likert-type scale that assesses the pros and cons of participating in genetic counseling/testing
  • Self-efficacy about participating in genetic counseling [ Time Frame: within one hour before the intervention and within one hour post-intervention ]
    Self-efficacy about participating in genetic counseling will be measured with a 5 point Likert-type scale (Sheppard et al., 2013)
  • 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 ]
    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
  • Health Literacy and Numeracy [ Time Frame: 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).
  • Mistrust about the medical system [ Time Frame: 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Testing an Intelligent Tutoring System to Enhance Genetic Risk Assessment
Official Title  ICMJE Testing an Intelligent Tutoring System Intervention to Enhance Genetic Risk Assessment in Underserved Blacks and Latinas at Risk of Hereditary Breast Cancer
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 Intelligent 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.
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 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 100 women from community/clinic sites. After completing a brief baseline survey, we will randomize participants to BRCA-gist (n=50) or NCI Webpage arms (n=50). We elected to use the NCI Webpage as a comparison as it includes current GCRA recommendations for women at increased risk, the content overlaps with BRCA-gist, and the NCI serves as a reputable source. Women will complete an immediate post-intervention assessment and a research assistant (RA) will refer them to local free genetic counseling services. Our primary outcome is GCRA uptake at 3 months. Knowledge, gist comprehension, and intentions will be secondary outcomes. We aim to:

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 two-arm RCT. 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 in the BRCA-gist arm (vs. NCI Web) will have a higher uptake of GCRA services 3 months after the intervention. H.2.4. Participants in the BRCA-gist arm (vs. NCI Webpage) will have a greater increase in knowledge, gist comprehension, and intentions to use GCRA. We will explore differences by ethnicity and health literacy and assess emotional reactions to risk information to inform future affective-tailored interventions.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants are randomized to two arms
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. After the baseline interview, the RA will be informed of the allocation by the staff member
Primary Purpose: Screening
Condition  ICMJE Hereditary Breast and Ovarian Cancer
Intervention  ICMJE
  • 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.
  • Behavioral: NCI Arm
    Participants randomized to the the NCI arm will have up to 90 minutes to read the information about HBOC and BRCA1/2 that overlaps with the content from the BRCA-Gist
Study Arms  ICMJE
  • Experimental: BRCA-Gist Intervention
    Participants randomized to BRCA-gist will complete the adapted intervention. 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.
    Intervention: Behavioral: BRCA-Gist
  • Active Comparator: NCI Arm
    Participants randomized to the NCI arm will have up to 90 minutes to read the NCI webpage content that overlaps with BRCA-gist.
    Intervention: Behavioral: NCI Arm
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 26, 2018)
140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2020
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Self-identify as Black and/or Latina
  • English proficiency
  • Be >21 years old
  • Be able to provide informed consent
  • Be at high risk of carrying HBOC mutation using personal/family cancer histories based on the NCCN guidelines

Exclusion Criteria:

  • Prior participation in genetic counseling
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Based on self-representation of gender identity
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Alejandra Hurtado de Mendoza, PhD 2026878916 ahd28@georgetown.edu
Contact: Sara Gomez Trillos, BA 2026870806 sg1328@georgetown.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03511690
Other Study ID Numbers  ICMJE 1R21NR016905-01A1( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alejandra Hurtado de Mendoza, Georgetown University
Study Sponsor  ICMJE Georgetown University
Collaborators  ICMJE Virginia Commonwealth University
Investigators  ICMJE
Principal Investigator: Alejandra H Hurtado de Mendoza, PhD Georgetown University
Principal Investigator: Vanessa Sheppard, PhD Virginia Commonwealth University
PRS Account Georgetown University
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP