Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Enhance the Use of Genetic Counseling and Testing in Latinas

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: NCT04544501
Recruitment Status : Enrolling by invitation
First Posted : September 10, 2020
Last Update Posted : September 22, 2020
Sponsor:
Collaborators:
Basser Center for BRCA
Nueva Vida, Inc.
Capital Breast Care Center
Virginia Commonwealth University
Arlington Free Clinic
Information provided by (Responsible Party):
Georgetown University

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Hereditary Breast and Ovarian Cancer Syndrome Behavioral: Culturally-Targeted Video Other: FORCE Fact Sheet Not Applicable

Detailed Description:

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

28 Latina women at risk for HBOC will be randomly assigned to one arm after completing the baseline assessment.

We will conduct a Hybrid Type 1 design to (1) test the effectiveness of two intervention approaches (video vs. FORCE fact sheet) in enhancing GCRA uptake and psychosocial outcomes and to (2) collect data on implementation outcomes regarding the interventions (video vs. FORCE fact sheet) and the implementation of a short screening survey to identify at-risk women.

Given the hybrid design, we will also conduct focus groups with clinic staff, in which we estimate 32 staff to participate. Given their participation in the focus groups, clinic staff are also considered participants, but they are not part of the randomized trial.

Masking: None (Open Label)
Primary Purpose: Screening
Official Title: A Randomized Controlled Trial to Enhance the Use of Genetic Counseling and Testing in Latinas
Actual Study Start Date : February 24, 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : April 2021


Arm Intervention/treatment
Experimental: Culturally-Targeted Video Behavioral: Culturally-Targeted Video
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.

Active Comparator: FORCE Fact Sheet Other: FORCE Fact Sheet
A publically available Spanish-language fact sheet about HBOC and GCRA developed by FORCE.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04544501


Locations
Layout table for location information
United States, District of Columbia
Capital Breast Care Center
Washington, District of Columbia, United States, 20003
United States, Virginia
Nueva Vida
Alexandria, Virginia, United States, 22314
Arlington Free Clinic
Arlington, Virginia, United States, 22204
Virginia Commonwealth University
Richmond, Virginia, United States, 23284
Sponsors and Collaborators
Georgetown University
Basser Center for BRCA
Nueva Vida, Inc.
Capital Breast Care Center
Virginia Commonwealth University
Arlington Free Clinic
Investigators
Layout table for investigator information
Principal Investigator: Alejandra Hurtado de Mendoza, Ph.D Georgetown University
Layout table for additonal information
Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT04544501    
Other Study ID Numbers: STUDY00001436
First Posted: September 10, 2020    Key Record Dates
Last Update Posted: September 22, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Georgetown University:
Latinas
Intervention
Additional relevant MeSH terms:
Layout table for MeSH terms
Hereditary Breast and Ovarian Cancer Syndrome
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Breast Neoplasms
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn
Breast Diseases
Skin Diseases