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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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.

Detailed Summary:

Breast cancer is the most diagnosed cancer for Latinas and is their leading cause of cancer death. Compared to non-Latina Whites, Latinas are diagnosed younger and with more advanced breast cancer. They also have the second highest prevalence of BRCA1 or BRCA2 gene mutations, that significantly increases their lifetime risk of developing hereditary breast and ovarian cancer (HBOC). The US Preventive Services Task Force recommends referral for genetic cancer risk assessments (genetic counseling and risk assessment as appropriate; GCRA) for women at high risk of carrying a mutation. GCRA informs treatment for survivors and risk management decisions in unaffected women. Latinas have lower GCRA use than Whites.

Explanations for Latinas' suboptimal GCRA participation include environmental (e.g. access) and psychosocial factors (e.g. low knowledge, emotions). There are numerous interventions to promote GCRA use in White populations and the mere handful of interventions that do target Latinas mostly consists of Mexicans or Puerto Ricans. Empirical evidence about successful strategies to improve GCRA uptake is lacking, especially from a growing population of Central/South American immigrants, a group with nuanced different barriers (e.g. social isolation). Our preliminary data suggests that improving access does not necessarily translate into higher GCRA uptake. Our data also highlighted providers' challenges in communicating GCRA risk information given the dearth of genetic materials in Spanish and Spanish-speaking genetic counselors. Media-based tools used to educate Latinas before GCRA are needed. This study will fill these gaps.

To be effective, risk HBOC communication interventions should be anchored within the needs and cultural values of their audience. This is because individuals process risk information in the context of
Sponsor: Georgetown University

Current Primary Outcome: Genetic counseling uptake [ Time Frame: three months post-intervention ]

Participation in genetic counseling services


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Intentions Scale [ Time Frame: within one hour before the intervention and within one hour post-intervention ]
    Intentions to use genetic counseling services
  • Knowledge Scale [ Time Frame: within one hour before the intervention and within one hour post-intervention ]
    Knowledge about hereditary breast and ovarian cancer
  • Attitudes Scale [ Time Frame: within one hour before the intervention and within one hour post-intervention ]
    Attitudes about participating in genetic counseling services
  • 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
  • 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


Original Secondary Outcome: Same as current

Information By: Georgetown University

Dates:
Date Received: February 22, 2017
Date Started: May 24, 2016
Date Completion: March 31, 2018
Last Updated: March 6, 2017
Last Verified: February 2017