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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE February 22, 2017
First Posted Date  ICMJE March 9, 2017
Last Update Posted Date September 17, 2019
Actual Study Start Date  ICMJE May 24, 2016
Estimated Primary Completion Date November 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2017)
Genetic counseling uptake [ Time Frame: three months post-intervention ]
Participation in genetic counseling services
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03075540 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2017)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Enhancing At-risk Latina Women's Use of Genetic Counseling for Hereditary Breast and Ovarian Cancer
Official Title  ICMJE 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 Description

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 "mental models" - one's intuitive beliefs based on personal experiences and shared cultural knowledge. Mental models influence the interpretation of new information. Often there is incongruence between lay and expert mental risk models that leads to miscommunication and uninformed decision-making. For example, among Latinas, the word "testing" led to the misconception that genetic testing would be repeated akin to other screening tests like mammography. Understanding Latinas' mental models will facilitate targeted risk communication to identify knowledge gaps and reduce misconceptions. Interventions that only address knowledge and/or beliefs may not enhance uptake, as risk information evokes emotional reactions that are often stronger predictors of behaviors than cognitive factors. Anticipated negative emotions to GCRA have been associated with lower uptake. Latinas report ambivalence towards GCRA that may impact their decisions. As most interventions have focused on knowledge and/or access, our study makes a considerable shift in the field by addressing mental models and targeting emotions.

This experienced multidisciplinary team will conduct a risk communication intervention designed to target mental models, emotions, and cultural values. Guided by the Theory of Planned Behavior and Social Cognitive Theory, the investigators will conduct a two-phased mixed methods study. In Phase I the investigators will interview key informants (n=10) and at-risk Latinas (n=20) to describe their mental models and other psychosocial factors. These data will inform the risk-benefit messages that will be evaluated in focus groups (n=20) and used to develop a YouTube-based intervention, which will be delivered via Latina actors and a trusted medical personality. In Phase II the investigators will pilot the intervention on at-risk Latinas (n=40). Participants will complete a baseline survey, watch the 15-minute video, complete a follow-up assessment, and be referred to a patient navigator for resources. The primary outcome is intentions to use GCRA. GCRA uptake will be assessed at 3-months. Specific aims are:

Aim 1. Describe and portray Latinas' GCRA mental models (e.g. risks and benefits perceptions).

Aim 2. Using data from Aim 1, develop the content of the risk-benefit communication messages for at-risk Latinas and incorporate these into a Spanish-language YouTube video.

Aim 3. Evaluate the acceptability and pre- and post-intervention differences on the primary outcome (intentions to use GCRA) and intermediate outcomes (e.g. attitudes). We will also explore post-intervention GCRA uptake as a secondary outcome. H.2.1. The intervention will result in a significant increase in intentions to use GCRA, and in H.2.2. improvements of intermediate outcomes: knowledge, attitudes, self-efficacy, and emotional ambivalence. H.2.3. After the intervention, 30% of Latinas will participate in GCRA by 3-months post-intervention. H.2.4. The majority (≥75%) will be satisfied with the intervention.

This study meets the Healthy People 2020 goals to enhance GCRA in at-risk populations, and the national priorities to increase diversity in genetics research participation and incorporate emotions into cancer research. Findings will inform new strategies for behavioral interventions targeting Latinas and a larger trial.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Single arm trial
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Hereditary Breast and Ovarian Cancer
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Behavioral: Genetic Counseling and Testing YouTube Video
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: March 6, 2017)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2019
Estimated Primary Completion Date November 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03075540
Other Study ID Numbers  ICMJE ADeMendoza
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Georgetown University
Study Sponsor  ICMJE Georgetown University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alejandra H Hurtado de Mendoza, PhD Georgetown University
PRS Account Georgetown University
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP