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Enhancing At-risk Latina Women's Use of Genetic Counseling for Hereditary Breast and Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT03075540
Recruitment Status : Active, not recruiting
First Posted : March 9, 2017
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Georgetown University

Brief Summary:
Compared to non-Latina Whites, Latinas have a higher prevalence of BRCA1/2 gene mutations but lower use of genetic cancer risk assessments services (GCRA). This study will develop and assess the impact of a novel culturally targeted media intervention to improve psychosocial outcomes and GCRA use in Latinas at-risk of hereditary breast and ovarian cancer. If the intervention is proven to be effective in a future randomized controlled trial, the intervention can be disseminated to clinics and adapted to other ethnic groups.

Condition or disease Intervention/treatment Phase
Hereditary Breast and Ovarian Cancer Behavioral: Genetic Counseling and Testing YouTube Video Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single arm trial
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Enhancing At-risk Latina Women's Use of Genetic Counseling for Hereditary Breast and Ovarian Cancer: Using Mental Models to Develop Culturally Targeted Media
Actual Study Start Date : May 24, 2016
Estimated Primary Completion Date : November 15, 2019
Estimated Study Completion Date : November 30, 2019


Arm Intervention/treatment
YouTube Video
Participants will watch a 15-minute YouTube video. The video will provide information about hereditary breast and ovarian cancer and about the process of genetic counseling and testing.
Behavioral: Genetic Counseling and Testing YouTube Video
Participants (n=40) will watch a 15-minute YouTube video that will describe the genetic counseling and testing process and risk/benefit information in a telenovela style format. Participants will complete pre- and post-assessments. After the session, participants interested in pursuing genetic counseling and testing services will be referred to the patient navigator at their respective sites, who will navigate participants to identified no cost or low cost services




Primary Outcome Measures :
  1. Genetic counseling uptake [ Time Frame: three months post-intervention ]
    Participation in genetic counseling services


Secondary Outcome Measures :
  1. Intentions Scale [ Time Frame: within one hour before the intervention and within one hour post-intervention ]
    Intentions to use genetic counseling services

  2. Knowledge Scale [ Time Frame: within one hour before the intervention and within one hour post-intervention ]
    Knowledge about hereditary breast and ovarian cancer

  3. Attitudes Scale [ Time Frame: within one hour before the intervention and within one hour post-intervention ]
    Attitudes about participating in genetic counseling services

  4. Self-efficacy Scale [ Time Frame: within one hour before the intervention and within one hour post-intervention ]
    Self-efficacy in participating in genetic counseling services

  5. emotional ambivalence Scale [ Time Frame: within one hour before the intervention and within one hour post-intervention ]
    emotional ambivalence about participating in genetic counseling services



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
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • self-identify as Latino/Hispanic, >21 years of age, and are at high risk of carrying a HBOC mutation using personal and family cancer histories based on the National Comprehensive Cancer Network

Exclusion Criteria:

  • not having the cognitive ability to provide informed consent

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): NCT03075540


Locations
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United States, District of Columbia
Capital Breast Care Center
Washington, District of Columbia, United States, 20003
United States, Virginia
Nueva Vida
Alexandria, Virginia, United States, 22314
Sponsors and Collaborators
Georgetown University
Investigators
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Principal Investigator: Alejandra H Hurtado de Mendoza, PhD Georgetown University

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Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT03075540     History of Changes
Other Study ID Numbers: ADeMendoza
First Posted: March 9, 2017    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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