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Testing an Intelligent Tutoring System to Enhance Genetic Risk Assessment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Hereditary Breast and Ovarian Cancer Behavioral: BRCA-Gist Behavioral: NCI Arm Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
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
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 : July 26, 2017
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020


Arm Intervention/treatment
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.
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.

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.
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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)

  3. 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.

  4. 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.

  5. 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

  6. 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).

  7. 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)

  8. 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

  9. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Based on self-representation of gender identity
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03511690


Contacts
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Contact: Alejandra Hurtado de Mendoza, PhD 2026878916 ahd28@georgetown.edu
Contact: Sara Gomez Trillos, BA 2026870806 sg1328@georgetown.edu

Locations
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United States, District of Columbia
Capital Breast Care Center Recruiting
Washington, District of Columbia, United States, 20003
Contact: Nathaly Gonzales    202-784-2705    ng472@georgetown.edu   
Contact: Lucille Adams-Campbell, PhD    (202) 687-5367    lla9@georgetown.edu   
Georgetown University Recruiting
Washington, District of Columbia, United States, 20007
Contact: Claudine Isaacs, MD    202-687-2219    isaacsc@georgetown.edu   
United States, Virginia
Nueva Vida Recruiting
Alexandria, Virginia, United States, 22314
Contact: Claudia Campos    202-223-9100    ccampos@nueva-vide.org   
Contact: Astrid Jimenez    202-223-9100    executivedirector@nueva-vida.org   
Principal Investigator: Vanessa B Sheppard, PhD         
Sub-Investigator: Valerie Reyna, PhD         
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23284
Contact: Arnethea Sutton, PhD       abrahamal@vcu.edu   
Contact: Vanessa Sheppard, PhD    1-804-628-2700    Vanessa.Sheppard@vcuhealth.org   
Sponsors and Collaborators
Georgetown University
Virginia Commonwealth University
Investigators
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Principal Investigator: Alejandra H Hurtado de Mendoza, PhD Georgetown University
Principal Investigator: Vanessa Sheppard, PhD Virginia Commonwealth University

Publications:

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Responsible Party: Alejandra Hurtado de Mendoza, Assistant Professor, Georgetown University
ClinicalTrials.gov Identifier: NCT03511690    
Other Study ID Numbers: 1R21NR016905-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 30, 2018    Key Record Dates
Last Update Posted: October 24, 2019
Last Verified: October 2019

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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, Georgetown University:
Latinas, African Americans
Additional relevant MeSH terms:
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Hereditary Breast and Ovarian Cancer Syndrome
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Breast Neoplasms
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn
Breast Diseases
Skin Diseases