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

NCT04476654 | Completed Results

• 4 other identifiers: MCC-19-15167HM20016234NCI-2019-04689R21CA236496
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

genetic counseling and testing

Outcome Measures

Primary Outcomes (1)

• Rate of Genetic Counseling and Testing Uptake.

  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.

  3 months

Secondary Outcomes (2)

• Knowledge Scale - Genetic Counseling and Testing Knowledge .

  Baseline was collected up to 48 hours from the start of the intervention and the follow-up was assessed within 48 hours post-intervention.

• Self-efficacy Scale

  Baseline was collected up to 48 hours from the start of the intervention and the follow-up was assessed within 48 hours post-intervention.

Study Arms (2)

Fact Sheet Arm

NO INTERVENTION

Komen print materials about genetic counseling and testing will be given to women.

YouTube Video Arm

ACTIVE COMPARATOR

Participants in this arm will receive the culturally tailored video either via a Youtube link or a DVD.

Behavioral: YouTube Video Arm

Interventions

YouTube Video Arm BEHAVIORAL

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.

YouTube Video Arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Massey Cancer Center

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Vanessa Sheppard
• Organization: Virginia Commonwealth University

vlbsheppard@vcu.edu

804-828-8892

Study Officials

• Vanessa Sheppard, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: July 20, 2020
• Study Start: November 1, 2021
• Primary Completion: June 12, 2023
• Study Completion: June 12, 2023
• Last Updated: October 22, 2024
• Results First Posted: October 22, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)