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Improving Uptake of Genetic Cancer Risk Assessment in African American Women- Video

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ClinicalTrials.gov Identifier: NCT04476654
Recruitment Status : Recruiting
First Posted : July 20, 2020
Last Update Posted : August 3, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief Summary:
Genetic counseling and testing (GCT) provides invaluable information for women who are at-risk of hereditary breast and/or ovarian cancer (HBOC). Black women underutilize GCT compared to White women. This study will conduct a RCT to test the efficacy of a culturally-tailored theory-based video intervention aimed to address key psychosocial factors (emotions, ambivalence) to improve uptake of genetic counseling in Black women at increased risk of HBOC. Findings from this study may offer an opportunity to engage at-risk Black women regarding genetic counseling through a multi-center trial and ultimately address the disparity in genetic counseling uptake that exists between Black and White women.

Condition or disease Intervention/treatment Phase
Breast Cancer Behavioral: YouTube Video Arm Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Improving Uptake of Genetic Cancer Risk Assessment in African American Women- Video
Actual Study Start Date : June 8, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Fact Sheet Arm
Komen print materials about genetic counseling and testing will be given to women.
Active Comparator: YouTube Video Arm
Participants in this arm will receive the culturally tailored video either via a Youtube link or a DVD.
Behavioral: YouTube Video Arm
Participants (n=25) will watch a 20 minute YouTube video that will describe the genetic counseling and testing process and risk/benefit information in a culturally relevant format. Participants will complete pre and post assessments. After the session, participants interested in pursuing genetic counseling and testing services will be referred to a patient navigator who will navigate participants to identified no cost or low cost services.




Primary Outcome Measures :
  1. Rate of genetic counseling and testing uptake. [ Time Frame: 3 months ]
    Our primary outcome will be for participants to receive genetic testing and counseling. Investigators will be able to see if participant has scheduled a genetic testing appointment within the VCU Health appointment system.


Secondary Outcome Measures :
  1. Knowledge Scale - Genetic counseling and testing knowledge . [ Time Frame: Within one hour before the intervention and within one hour post-intervention. ]
    The investigators will test general knowledge about hereditary breast and ovarian cancer

  2. Self-efficacy Scale [ Time Frame: Within one hour before the intervention and within one hour post-intervention. ]
    The investigators will test self-efficacy in genetic counseling services.

  3. Emotional Ambivalence Scale [ Time Frame: Within one hour before the intervention and within one hour post-intervention. ]
    The investigators will test the emotional ambivalence about participating in genetic counseling services.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be at least 18 years of age
  • Must be at high risk for hereditary breast or ovarian cancer
  • Must identify as Black/African American
  • Must be a woman
  • Referred to a genetic counselor for the purpose of being high risk of carrying a hereditary breast and/or ovarian cancer mutation

Genetic Counselors:

  • Must be at least 18 years of age
  • Must be qualified
  • Must be approved by the PI

Exclusion Criteria:

  • Under the age of 18
  • Race other than Black/African American
  • Do not gave a high risk for hereditary breast or ovarian cancer

Genetic Counselors:

  • Under 18
  • Not qualified
  • Not approved by the PI

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): NCT04476654


Contacts
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Contact: Vanessa B Sheppard, PhD 804-628-2700 vanessa.sheppard@vcuhealth.org
Contact: Arnethea Sutton, PhD 804-628-3083 arnethea.sutton@vcuhealth.org

Locations
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United States, Virginia
Massey Cancer Center Recruiting
Richmond, Virginia, United States, 23298
Contact: Vanessa B Sheppard, PhD    804-628-2700    vanessa.sheppard@vcuhealth.org   
Sponsors and Collaborators
Virginia Commonwealth University
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Vanessa Sheppard, PhD Virginia Commonwealth University
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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT04476654    
Other Study ID Numbers: MCC-19-15167
HM20016234 ( Other Identifier: VCU IRB )
NCI-2019-04689 ( Other Identifier: CTRP )
R21CA236496 ( U.S. NIH Grant/Contract )
First Posted: July 20, 2020    Key Record Dates
Last Update Posted: August 3, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Virginia Commonwealth University:
genetic counseling and testing