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Hereditary Breast and Ovarian CancerNCT03075540

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

A study testing Genetic Counseling and Testing YouTube Video in people with Hereditary Breast and Ovarian Cancer, run by Georgetown University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 21 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Hereditary Breast and Ovarian Cancer
What is being tested?
Genetic Counseling and Testing YouTube Video
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
2 sitesUnited States
Study dates
24 May 2016to 15 Nov 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • not having the cognitive ability to provide informed consent

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Nueva Vida

    Alexandria, Virginia, 22314

  • Capital Breast Care Center

    Washington D.C., District of Columbia, 20003

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Genetic Counseling and Testing YouTube Video
Keywords
Latinas
Medical subject headings
Hereditary Breast and Ovarian Cancer Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Genetic Counseling and Testing YouTube VideoBehavioural

    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 groups in NCT03075540
Study groupRoleWhat they receive
YouTube VideoOtherParticipants 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.
Receives: Behavioral: Genetic Counseling and Testing YouTube Video

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Genetic counseling uptake

    Participation in genetic counseling services

    Measured: three months post-intervention

Secondary outcomes (5)
  1. Intentions Scale

    Intentions to use genetic counseling services

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

  2. Knowledge Scale

    Knowledge about hereditary breast and ovarian cancer

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

  3. Attitudes Scale

    Attitudes about participating in genetic counseling services

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

  4. Self-efficacy Scale

    Self-efficacy in participating in genetic counseling services

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

  5. emotional ambivalence Scale

    emotional ambivalence about participating in genetic counseling services

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2017
  2. Study start24 May 2016
  3. Primary completion15 Nov 2019
  4. Study completion15 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Model description
Single arm trial
Masking
None (open label)
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03075540
Sponsor's protocol ID
ADeMendoza
Status last verified
Sep 2019
First submitted
22 Feb 2017
Last updated
12 Dec 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40883500
  • 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.

    PubMed 31883202

Questions about this trial

What is this clinical trial studying?

A study testing Genetic Counseling and Testing YouTube Video in people with Hereditary Breast and Ovarian Cancer, run by Georgetown University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Genetic counseling uptake (time frame: three months post-intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03075540, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2019.

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