Testing an Intelligent Tutoring System to Enhance Genetic Risk Assessment

NCT03511690 | Completed DMC

• 1 other identifier: 1R21NR016905-01A1
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 4

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.

Conditions

Hereditary Breast and Ovarian Cancer

Keywords

Latinas, African Americans

Outcome Measures

Primary Outcomes (3)

• Breast Cancer Genetics Knowledge

  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.

  Aim 2. From baseline to two week after the baseline.

• Intentions to participate in genetic counseling

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

  Aim 2. From baseline to two week after the baseline.

• Perceived pros and cons of genetic counseling and testing

  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.

  Aim 2. From baseline to two week after the baseline.

Secondary Outcomes (7)

• Uptake of Genetic Counseling

  Two weeks after the intervention

• Self-efficacy about participating in genetic counseling

  within one hour before the intervention and within one hour post-intervention

• Emotions about developing breast cancer and about participating in genetic counseling

  within one hour before the intervention and within one hour post-intervention

• Health Literacy and Numeracy

  within one hour before the intervention

• Mistrust about the medical system

  within one hour before the intervention

Study Arms (2)

Immediate BRCA-Gist Intervention

EXPERIMENTAL

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

Delayed BRCA-Gist Intervention

EXPERIMENTAL

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

Interventions

BRCA-Gist BEHAVIORAL

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.

Delayed BRCA-Gist Intervention; Immediate BRCA-Gist Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Based on self-representation of gender identity
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Prior participation in genetic counseling or genetic testing for hereditary cancer risk.

Sponsors & Collaborators

• Georgetown University: lead
• Virginia Commonwealth University: collaborator
• Cornell University: collaborator

Study Sites (4)

Capital Breast Care Center

Washington D.C., District of Columbia, 20003, United States

Location

Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

Nueva Vida

Alexandria, Virginia, 22314, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23284, United States

Location

Related Publications (24)

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MeSH Terms

Conditions

Hereditary Breast and Ovarian Cancer Syndrome

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplastic Syndromes, Hereditary; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Alejandra H Hurtado de Mendoza, PhD

  Georgetown University

  PRINCIPAL INVESTIGATOR

• Vanessa Sheppard, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants are randomized to an immediate or delayed arm

Study Record Dates

• First Submitted: April 16, 2018
• First Posted: April 30, 2018
• Study Start: July 1, 2017
• Primary Completion: February 20, 2022
• Study Completion: February 20, 2022
• Last Updated: April 25, 2022

Record last verified: 2022-04

Locations

US (4)