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

NCT03075540 | Completed

• 1 other identifier: ADeMendoza
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 2

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.

Conditions

Hereditary Breast and Ovarian Cancer

Keywords

Latinas

Outcome Measures

Primary Outcomes (1)

• Genetic counseling uptake

  Participation in genetic counseling services

  three months post-intervention

Secondary Outcomes (5)

• Intentions Scale

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

• Knowledge Scale

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

• Attitudes Scale

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

• Self-efficacy Scale

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

• emotional ambivalence Scale

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

Study Arms (1)

YouTube Video

OTHER

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

Interventions

Genetic Counseling and Testing YouTube Video BEHAVIORAL

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

YouTube Video

Eligibility Criteria

• Age: 21 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• not having the cognitive ability to provide informed consent

Sponsors & Collaborators

• Georgetown University: lead

Study Sites (2)

Capital Breast Care Center

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

Location

Nueva Vida

Alexandria, Virginia, 22314, United States

Location

Related Publications (2)

• Gomez-Trillos S, Carrera P, Caballero A, Sheppard VB, Graves KD, Peshkin BN, Schwartz MD, Campos C, Garces N, Mendoza AH. 'How Did That Make You Feel?' Latinas' Use of Genetic Counseling and Testing for Hereditary Cancer Risk After Watching a Culturally Targeted Video and Receiving Patient Navigation. Psychooncology. 2025 Sep;34(9):e70261. doi: 10.1002/pon.70261.

  PMID: 40883500 DERIVED

• Gomez-Trillos S, Sheppard VB, Graves KD, Song M, Anderson L, Ostrove N, Lopez K, Campos C, Gonzalez N, Hurtado-de-Mendoza A. Latinas' knowledge of and experiences with genetic cancer risk assessment: Barriers and facilitators. J Genet Couns. 2020 Aug;29(4):505-517. doi: 10.1002/jgc4.1201. Epub 2019 Dec 27.

  PMID: 31883202 DERIVED

MeSH Terms

Conditions

Hereditary Breast and Ovarian Cancer Syndrome

Interventions

Genetic Counseling

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

Intervention Hierarchy (Ancestors)

Genetic Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Alejandra H Hurtado de Mendoza, PhD

  Georgetown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single arm trial

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: March 9, 2017
• Study Start: May 24, 2016
• Primary Completion: November 15, 2019
• Study Completion: November 15, 2019
• Last Updated: December 12, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)