Breast Cancer RiskNCT04082117
Uptake of Genetic Counseling Among African American Women
A study testing Educational video in people with Breast Cancer Risk, run by University of Illinois Chicago at 2 sites in United States.
Trial summary
A feasibility study incorporating an educational intervention with cancer genetic risk assessment (CGRA) in the UI Health mammography center Read more about this study
- Who is it for?
- Ages 25 to 69 years, women only
- Conditions the study is for
- Breast Cancer Risk
- What is being tested?
- Educational video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 960 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 May 2017to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 to 69 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- African American female age 25-69 years
- Presenting for mammogram at UI Health mammography clinic
- No prior history of breast cancer
- Completed cancer genetic risk assessment (CGRA) in UI Health mammography center
- Recommended for genetic counseling based on CGRA performed at the time of the mammogram.
Who cannot join
- Unable to complete the informed consent and survey in English
- Previously had genetic counseling for hereditary breast cancer risk
- Prisoners
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Illinois Health System
Chicago, Illinois, 60612
University of Illinois
Chicago, Illinois, 60612
About this study
Official title: Creating a Culturally-Tailored Intervention to Improve Uptake of Genetic Counseling Among Underserved African American Women With Increased Breast Cancer Risk
A feasibility study incorporating an educational intervention with cancer genetic risk assessment (CGRA) in the UI Health mammography center
Read the detailed description
African American (AA) women with a family history of breast cancer who are eligible for genetic counseling and express an interest in participating in the study will be consented and complete a brief survey before and after viewing an educational video on genetic counseling. Survey questions will be read to each participant. The questions capture data on the following constructs regarding genetic counseling: knowledge, attitudes, normative beliefs, motivation, perceived social norms, intention, efficacy beliefs, skills, environmental constraints and opinions on the video. The research team will conduct a review of the UI Health Electronic Medical Record (EMR) 3-6 months after study enrollment to determine if the participant attended a genetic counseling session.
- Conditions
- Breast Cancer Risk
- Being tested
- Educational video
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational videoBehavioural
Educational genetic counseling video
| Study group | Role | What they receive |
|---|---|---|
| Open Label | Other | Educational genetic counseling video Receives: Behavioral: Educational video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge and intentions regarding genetic counseling
Change in knowledge of genetic counseling and intention to engage in genetic counseling following viewing of educational video based on response to survey designed by study investigators.
Measured: 1 hour
Secondary outcomes (1)
Attendance at genetic counseling appointment
Rate that study participants attend a genetic counseling appointment within 3 months of viewing educational video
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start12 May 2017
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer RiskStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Educational genetic counseling video
- Masking
- None (open label)
- Enrolment
- 960 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kent F. Hoskins, MD, University of Illinois Chicago
- Investigators
- Kent Hoskins, M.D., Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04082117
- Sponsor's protocol ID
- 2016-1219
- Status last verified
- Jul 2025
- First submitted
- 5 Sep 2019
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Henderson V, Madrigal JM, Kendall LC, Parekh P, Newsome J, Chukwudozie IB, Comer-Hagans L, Coffey V, Grumbach G, Spencer S, Rodgers C, Kaur R, Balay L, Maga T, Ramamonjiarivelo Z, Balthazar C, Winn R, Watson K, Odoms-Young A, Hoskins KF. Pilot study of a culturally sensitive intervention to promote genetic counseling for breast cancer risk. BMC Health Serv Res. 2022 Jun 25;22(1):826. doi: 10.1186/s12913-022-08193-x.
PubMed 35752812
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creating a Culturally-Tailored Intervention to Improve Uptake of Genetic Counseling Among Underserved African American Women With Increased Breast Cancer Risk
- ClinicalTrials.gov ID
- NCT04082117
- Acronym / sponsor ID
- 2016-1219
- Conditions
- Breast Cancer Risk
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 960 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 12 May 2017 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 9 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A feasibility study incorporating an educational intervention with cancer genetic risk assessment (CGRA) in the UI Health mammography center
Detailed description
African American (AA) women with a family history of breast cancer who are eligible for genetic counseling and express an interest in participating in the study will be consented and complete a brief survey before and after viewing an educational video on genetic counseling. Survey questions will be read to each participant. The questions capture data on the following constructs regarding genetic counseling: knowledge, attitudes, normative beliefs, motivation, perceived social norms, intention, efficacy beliefs, skills, environmental constraints and opinions on the video. The research team will conduct a review of the UI Health Electronic Medical Record (EMR) 3-6 months after study enrollment to determine if the participant attended a genetic counseling session.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Educational genetic counseling video
| Arm | Type | Receives |
|---|---|---|
| Open Label | Other | Behavioral: Educational videoEducational genetic counseling video |
Who may qualify
- Ages
- 25 to 69 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- African American female age 25-69 years
- Presenting for mammogram at UI Health mammography clinic
- No prior history of breast cancer
- Completed cancer genetic risk assessment (CGRA) in UI Health mammography center
- Recommended for genetic counseling based on CGRA performed at the time of the mammogram.
Key exclusion criteria (3 listed)
- Unable to complete the informed consent and survey in English
- Previously had genetic counseling for hereditary breast cancer risk
- Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational videoEducational genetic counseling video | Behavioural | Open Label |
Primary outcome
Knowledge and intentions regarding genetic counseling
Time frame: 1 hour
Change in knowledge of genetic counseling and intention to engage in genetic counseling following viewing of educational video based on response to survey designed by study investigators.
1 secondary outcome
Attendance at genetic counseling appointment
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Derived from this study: PubMed 35752812Henderson V, Madrigal JM, Kendall LC, Parekh P, Newsome J, Chukwudozie IB, Comer-Hagans L, Coffey V, Grumbach G, Spencer S, Rodgers C, Kaur R, Balay L, Maga T, Ramamonjiarivelo Z, Balthazar C, Winn R, Watson K, Odoms-Young A, Hoskins KF. Pilot study of a culturally sensitive intervention to promote genetic counseling for breast cancer risk. BMC Health Serv Res. 2022 Jun 25;22(1):826. doi: 10.1186/s12913-022-08193-x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kent Hoskins, M.D. principal investigator
University of Illinois Chicago
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational video in people with Breast Cancer Risk, run by University of Illinois Chicago 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 5 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 14 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Knowledge and intentions regarding genetic counseling (time frame: 1 hour). 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 NCT04082117, which also lists 1 linked publication.
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 14 Jul 2025.