AzTrials
AzTrials

High Risk for Breast CancerNCT04378751

Promoting Genetic Counseling Among African American Women With a Family History of Breast Cancer

A study testing Decision aid video and Genetic counseling informational brochure in people with High Risk for Breast Cancer, run by University of Illinois Chicago at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

In the United States, carriers of hereditary genetic mutations have up to an 85% risk of developing breast cancer compared to 12% in the general population. Overall uptake of genetic services is generally low, particularly among high-risk African American (AA) women, who carry a disproportionate burden of breast… Read more about this study

Who is it for?
Ages 25 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
High Risk for Breast Cancer
What is being tested?
Decision aid video and Genetic counseling informational brochure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
2 sitesUnited States
Study dates
6 Jun 2023to 31 May 2025
Phase
Interventional
Are there results?
None posted in the registry

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 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Are female
  • Identify as African American
  • Are age 25 or older
  • Speak and understand English
  • Completed a cancer genetic risk assessment (CGRA) as part of clinic intake
  • Are classified as high risk for developing breast cancer per CGRA
  • Have not previously received genetic counseling

Who cannot join

  • Are not female
  • Do not identify as African American
  • Are age 24 or younger
  • Do not speak and understand English
  • Did not complete a cancer genetic risk assessment (CGRA) as part of clinic intake
  • Are not classified as high risk for developing breast cancer per CGRA
  • Have previously received genetic counseling

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • UIC Cancer Center

    Chicago, Illinois, 60612

  • University of Illinois at Chicago Hospital and Ambulatory Clinics

    Chicago, Illinois, 60612

Other trials in United States

About this study

In the United States, carriers of hereditary genetic mutations have up to an 85% risk of developing breast cancer compared to 12% in the general population. Overall uptake of genetic services is generally low, particularly among high-risk African American (AA) women, who carry a disproportionate burden of breast cancer mortality. Further, although testing close relatives of individuals who test positive for a pathogenic variant might curtail breast cancer disparities attributable to hereditary risk, it is unclear how counseled or tested individuals influence their social and familial networks. Using a randomized control trial design, the objective of this research project is to test the effectiveness of a culturally targeted video, previously developed by our research team, on promoting genetic counseling attendance among AA women determined to be at high risk for breast cancer through cancer genetic risk assessment in a clinical setting. This study will also test how psychosocial factors (knowledge, intrinsic motivation, risk perception, and distress) impact the relationships between intervention exposures (video versus brochure) and compare the impact of intervention exposures on diffusion of knowledge about genetic counseling through social network analysis.

Read the detailed description

Study Design. The investigator will conduct a randomized control trial single-blind control trial to test the effectiveness of a culturally targeted decision aid video to promote genetic counseling among African American determined to be high risk for breast cancer through cancer genetic risk assessment. Eligible patients will be randomly assigned to receive information about genetic counseling using a culturally targeted decision aid video (treatment group) or a brochure (control).

Research Protocol. As part of standard of care, patients will complete a cancer genetic risk assessment (CGRA) as part of intake on a tablet computer provided by the front desk clinic staff. CGRA results will be uploaded to the EMR, printed and given to a patient navigator. The patient navigator will approach patients, give them a recruitment flyer, information about the study, screen patients and obtain informed consent for women who choose to participate in the study. Based on computer-generated randomization (equal numbers in each arm), patients will be randomized to one of two groups to receive: 1) pretest, view decision aid video, and posttest or 2) pretest, genetic counseling brochure, and posttest. Both arms will be facilitated by patient navigators. Upon completion of posttest, patient navigators will ask women if they would like to make an appointment for genetic counseling, contact the provider for the order if not already in the EMR, make genetic counseling appointments for women who choose to attend, and monitor and collect follow-up data. All enrolled participants will receive a phone call at 4 weeks post-intervention to (a) verify counseling attendance through self-report and EMR extraction if applicable; (b) ask whether the patient was referred to genetic testing after her genetic counseling if applicable; and (c) ask whether other family members were referred to genetic services if applicable and (d) determine who in their social networks, if anyone, the participant told about genetic counseling, and if so, how this information was shared.

Being tested
Decision aid video, Genetic counseling informational brochure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Decision aid videoBehavioural

    Decision aid video

  • Genetic counseling informational brochureBehavioural

    Genetic counseling informational brochure

Study groups in NCT04378751
Study groupRoleWhat they receive
Decision aid videoExperimentalParticipants receiving the intervention will complete a pretest, watch the decision aid video, and complete posttest via tablet computer facilitated by Patient Navigators.
Receives: Behavioral: Decision aid video
Genetic counseling informational brochureActive comparatorParticipants receiving the control will complete pretest, review a genetic counseling brochure with the Patient Navigators, and complete posttest via tablet computer facilitated by a Patient Navigator.
Receives: Behavioral: Genetic counseling informational brochure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Genetic Counseling Attendance

    Compare the effects of intervention vs. control arm on genetic counseling attendance among African American women recommended for genetic counseling through cancer genetic risk assessment.

    Assessed via EMR and survey at follow-up.

    2-item (Did patient complete genetic counseling appointment? A) Self-report and B) EMR)

    1 items assessing familial referral to genetic counseling or testing

    Measured: 52 weeks

Secondary outcomes (6)

  1. Decision Aid Usability

    5-item agreement likert scale to assess usability, satisfaction, decisional conflict (e.g., I felt I could relate to what the actors were saying?)

    Assessed via survey at immediate posttest

    Measured: 52 weeks

  2. Knowledge about Genetic Counseling

    Items to assess changes in knowledge about genetic counseling for breast cancer risk between pre and post intervention; (e.g., A purpose of genetic counseling is to help people understand their options for genetic testing.)

    Relevant items from published instrument (Maio) and Facing Our Risk of Cancer Empowerment (FORCE) brochure (control arm brochure) adapted for genetic counseling for breast cancer.

    Assessed via survey at pretest and posttest.

    Measured: 52 weeks

  3. Distress Associated with Genetic Counseling and Breast Cancer Risk

    Items to assess patient worry/anxiety related to genetic counseling and breast cancer risk; (e.g., How often have you thought about your chances of getting cancer?)

    7-item Cancer Worry Scale

    Assessed via survey at pretest and posttest.

    Measured: 52 weeks

  4. Intrinsic Motivation for Genetic Counseling Attendance

    Items to assess motivation for genetic counseling attendance (e.g., The reason I would attend genetic counseling is because I feel that I want to take responsibility for my own health.)

    15-item Treatment Self-Regulation Questionnaire and 4-item Self-Efficacy Scale

    Assessed via survey at pretest and posttest.

    Measured: 52 weeks

  5. Risk Perception Associated with Breast Cancer

    Items to assess perception of risk related to getting breast cancer (In your opinion, compared to other women your age, what are your chances of getting breast cancer?)

    1-item question obtained from published instrument.

    Assessed via survey at pretest and posttest.

    Measured: 52 weeks

  6. Diffusion of Knowledge

    Items to assess sharing of knowledge among social and familial networks about genetic counseling. Diffusion of knowledge will be assessed by collecting data on social network size, composition, density, and information sharing related to genetic counseling and risks.

    Relevant social network assessment items-General Social Survey.

    Examples:

    • Name generator: (From time to time, most people discuss important matters with other people. Looking back over the past month, who are the people with whom you discussed genetic counseling or genetic risks?
    • Name interpreter: (e.g., What is relationship between you and X?)

    Assessed at 4 week follow-up

    Measured: 56 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2020
  2. Study start6 Jun 2023
  3. Primary completion31 May 2025
  4. Study completion31 May 2025

Resources

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
Screening
Allocation
Randomised
Intervention model
Parallel groups
Model description
Computer-generated randomization (equal numbers in each arm), patients will be randomized to one of two arms: 1. Decision aid video 2. Genetic counseling informational brochure
Masking
Single blind
Who is masked
Participant
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04378751
Sponsor's protocol ID
2020-0342
Other IDs
K01CA248852-01
Status last verified
Aug 2025
First submitted
1 May 2020
Last updated
24 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Decision aid video and Genetic counseling informational brochure in people with High Risk for Breast Cancer, 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 7 inclusion and 7 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: finished, as of the sponsor's last update on 24 Aug 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Genetic Counseling Attendance (time frame: 52 weeks). 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 NCT04378751.

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 24 Aug 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in