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
|Condition or disease||Intervention/treatment||Phase|
|Hereditary Breast and Ovarian Cancer||Behavioral: BRCA-Gist Behavioral: NCI Arm||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|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|
|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|
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.
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
- 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.
- 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.
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
|Contact: Alejandra Hurtado de Mendoza, PhDfirstname.lastname@example.org|
|Contact: Sara Gomez Trillos, BAemail@example.com|
|United States, District of Columbia|
|Capital Breast Care Center||Recruiting|
|Washington, District of Columbia, United States, 20003|
|Contact: Nathaly Gonzales 202-784-2705 firstname.lastname@example.org|
|Contact: Lucille Adams-Campbell, PhD (202) 687-5367 email@example.com|
|Washington, District of Columbia, United States, 20007|
|Contact: Claudine Isaacs, MD 202-687-2219 firstname.lastname@example.org|
|United States, Virginia|
|Alexandria, Virginia, United States, 22314|
|Contact: Claudia Campos 202-223-9100 email@example.com|
|Contact: Astrid Jimenez 202-223-9100 firstname.lastname@example.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 email@example.com|
|Contact: Vanessa Sheppard, PhD 1-804-628-2700 Vanessa.Sheppard@vcuhealth.org|
|Principal Investigator:||Alejandra H Hurtado de Mendoza, PhD||Georgetown University|
|Principal Investigator:||Vanessa Sheppard, PhD||Virginia Commonwealth University|