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Completed

NCT Number: NCT04544501

Enhance the Use of Genetic Counseling and Testing in Latinas

The investigators will conduct a two-arm RCT to evaluate the preliminary effectiveness of a culturally-adapted video developed by the team vs. a FORCE fact sheet on enhancing genetic cancer risk assessment (GCRA; including genetic counseling and option for genetic testing) uptake and psychosocial outcomes among Latinas at increased risk for hereditary breast and ovarian cancer (HBOC).

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Key information

Conditions

Hereditary Breast and Ovarian Cancer Syndrome Adnexal Diseases Breast Diseases Breast Neoplasms Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Neoplastic Syndromes, Hereditary Ovarian Diseases Ovarian Neoplasms Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Capital Breast Care Center, Washington D.C., District of Columbia, United States

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About this study

The investigators will conduct a two-arm RCT to evaluate the preliminary effectiveness of a culturally-adapted video developed by the team vs. FORCE fact sheet on enhancing genetic cancer risk assessment (GCRA; including genetic counseling and option for genetic testing) uptake and psychosocial outcomes among Latinas at increased risk for hereditary breast and ovarian cancer (HBOC).

All participants will receive referrals to free telephone genetic counseling in Spanish to address cost, pragmatic, and language barriers. The investigators will recruit 28 Latina women at-risk of HBOC (14 randomized at each arm) at three sites with sizable Latinx populations. The sites include community clinics/health organizations and hospitals with whom we have established collaborations [Georgetown University (DC); Virginia Commonwealth University (VA)].

Results will improve efforts to translate genomic guidelines into practice and will reduce disparities by evaluating a low cost highly disseminable culturally-targeted video while gathering data on effectiveness and implementation.

Aim 1. Evaluate the impact of video vs. FORCE fact sheet on GCRA and testing uptake and psychosocial outcomes.

Aim 2. Assess implementation potential and needs by evaluating feasibility, acceptability, reach, and adoption of the intervention arms (video and FORCE fact sheet) and of the HBOC screening process at the community clinics.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Older than 18 years-old
  • Self-identify as Latina
  • Fluent in Spanish
  • Meet NCCN criteria for breast and/or ovarian genetic cancer risk assessment based on -personal or family history of cancer
  • Have not received genetic counseling or genetic testing
  • Able to provide informed consent
  • No other members of the same family have participated
  • Must have access to the internet via smartphone, computer, or another device.

Exclusion criteria

  • Not fluent in Spanish
  • Previously received genetic counseling or genetic testing for HBOC
  • Previously participated in another interventional study about HBOC and GCRA

Treatment and study plan

Culturally-Targeted Video

Behavioral

Culturally targeted narrative video: "Is My Cancer Hereditary? Rosa Visits a Genetic Counselor." With R03 funding (R03CA191543) we developed a culturally targeted narrative video for at-risk Latinas. A multidisciplinary team of researchers collaborated with filmmakers to develop the script and video. The script was informed by health behavior conceptual models, evidence-based risk communication strategies, and formative research (40 interviews with providers and at-risk Latinas). The script addressed identified knowledge gaps (e.g., incorrect belief that pap smears screen for ovarian cancer), facilitators (e.g., inform family cancer risk), barriers (e.g., emotional concerns), and cultural factors (e.g., respect). The 18-minute video illustrates the GCRA process with the story of Rosa, a Latina cancer survivor at increased risk of HBOC. Rosa learns about HBOC risk factors, overcomes barriers, and attends genetic counseling.

FORCE Fact Sheet

Other

A publically available Spanish-language fact sheet about HBOC and GCRA developed by FORCE.

Primary outcomes

  1. Genetic counseling uptake

    Time frame: Baseline survey to three months after baseline

    Proportion of participants that receive genetic counseling. The outcome will be assessed by self-report (e.g., Have you received genetic counseling in the past three months?) and confirmed with the genetic counseling company records.

Secondary outcomes

  1. Genetic testing uptake

    Time frame: Baseline survey to three months after baseline

    Proportion of participants that receive genetic testing. The outcome will be assessed by self-report (e.g., Have you received genetic testing in the past three months?) and confirmed with the genetic counseling company records.

Other outcomes

  1. Breast cancer genetics knowledge

    Time frame: Change from baseline to two weeks after baseline and change from baseline to three months after baseline

    Change in knowledge about HBOC and GCRA. Knowledge will be measured using a 13-item Erblich et al., 2005 scale about genetic knowledge about breast cancer. The scale has statements to which participants respond True, False, or I don't Know. The scale is scored based on the accuracy of responses. A higher score indicates higher knowledge. Scores range from 0-13.

  2. Intentions to participate in genetic counseling and genetic testing

    Time frame: Baseline to two weeks after baseline

    Change in intentions to participate in genetic counseling and genetic testing. A 2-item scale developed by Sussner, Jandorf, Thompson, and Valdimarsdottir, 2010 will be used to assess intentions to participate in genetic counseling and testing. Participants respond to a Likert-trype scale from 1 (Not at all) to 5 (Very) how likely it is that they will participate in genetic counseling and testing in the next three months.

  3. Beliefs and attitudes about genetic counseling and genetic testing

    Time frame: Baseline to two weeks after baseline

    Changes in beliefs and attitudes about genetic counseling and genetic testing. The outcome will be assessed by a 30-item scale developed by Sussner, Jandorf, Thompson et al., 2012 in which participants respond to a Likert-type scale from 1 (completely disagree) to 7 (complete agree).

  4. Anticipatory Emotions

    Time frame: Baseline to two weeks after baseline

    Changes in anticipatory emotions about receive genetic counseling. Assessed by participants' responses to how they feel 'right now' about the specific behavior of receiving genetic counseling and testing in the next three months. Responses are in a 7-point Likert-type form (from 1-strongly disagree to 7-strongly agree).

Sponsors and collaborators

Lead sponsor

Georgetown University

Other

Collaborators

  • Arlington Free Clinic
  • Basser Center for BRCA
  • Capital Breast Care Center
  • Nueva Vida, Inc.
  • Virginia Commonwealth University

Registry information

Official study title

A Randomized Controlled Trial to Enhance the Use of Genetic Counseling and Testing in Latinas

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 10, 2020
Registry last updated
May 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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