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Female Breast CancerNCT07436078

Culturally Adapting an Intervention to Increase Genetic Testing in African American Cancer Survivors

A study testing Culturally adapted Online Genetic Counseling and Testing Information in people with Female Breast Cancer and Prostate Cancer, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

The goal of this clinical trial is to culturally adapt an educational genetic counseling intervention to increase the uptake in genetic counseling and testing among African Americans at risk for heredity cancers. Read more about this study

Who is it for?
Ages 20 to 79 years
What is being tested?
Culturally adapted Online Genetic Counseling and Testing Information
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
1 siteUnited States
Study dates
18 Apr 2026to Jul 2029
Phase
Interventional

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 20 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants enrolled in Detroit Research on Cancer Survivors (Detroit ROCS)
  • Diagnosis of Primary Breast, prostate, or colorectal cancer on or after 1/1/2013
  • have received or currently receiving care at Karmanos Cancer Institute
  • meet one or more of the National Comprehensive Cancer Network (NCCN) guidelines for cancer genetic testing as described below
  • Female breast
  • personal diagnosis at age ≤50
Show all 21Show fewer
  • personal history of the triple-negative subtype
  • at least 1 close (first- or second-degree) relative diagnosed with breast cancer at age <50
  • at least 1 close relative diagnosed with ovarian cancer
  • 2+ close relatives diagnosed with breast or prostate cancer
  • age <50 AND another primary breast cancer at any age
  • 2+ primary breast cancers at any age
  • OR Prostate
  • personal history of high-risk or very high-risk prostate cancer
  • personal history of regional or metastatic prostate cancer
  • personal history of less than high-risk prostate cancer with a suggestive family history (i.e., father or brother or multiple relatives with prostate cancer diagnosed at age <60; at least 1 relative with breast, ovarian, or pancreatic cancer; or at least 1 relative with colorectal, ovarian, pancreatic, or kidney cancer)
  • OR Colorectal
  • personal diagnosis at age ≤50
  • at least 1 close relative diagnosed with HNPCC at age <50
  • at least 2 close relatives diagnosed with an HNPCC cancer at any age
  • colorectal and >=1 primary endometrial, ovarian, gastric, pancreatic, or prostate

Who cannot join

  • Previous genetic counseling and/or testing

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jasminder Phalore, MPH contact

313-576-9735

phalorej@karmanos.org

United States1 site, 1 recruiting
  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

    Jasminder Phalore, MPH, 313-576-9735, phalorej@karmanos.org

    Hayley Thompson, Ph.D

    Recruiting

Other trials in United States

About this study

Official title: A Community-Engaged Approach to Culturally Adapting an Intervention to Increase Uptake of Genetic Testing Among African American Cancer Survivors

The goal of this clinical trial is to culturally adapt an educational genetic counseling intervention to increase the uptake in genetic counseling and testing among African Americans at risk for heredity cancers. With the help of community stakeholders and clinical genetic professionals the investigators will:

  • adapt and refine a culturally relevant online educational genetic counseling program for at-risk African Americans
  • Test the effects of the educational program
  • collaborate with community leaders and clinical genetic professionals to translate study findings, develop a road map for dissemination to the community, and identify barriers to prepare for future trials.

Participants from Detroit Research on Cancer Survivor group will be offered enrollment. Once consent is obtained, questionnaires will be completed before an online genetic counselling intervention immediately after, and at 3 months

Being tested
Culturally adapted Online Genetic Counseling and Testing Information
Medical subject headings
Prostatic Neoplasms, Colorectal Neoplasms

What participants receive

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

  • Culturally adapted Online Genetic Counseling and Testing InformationBehavioural

    Testing the effects of the educational intervention designed to increase the uptake of genetic counseling testing among at-risk African American survivors

Study groups in NCT07436078
Study groupRoleWhat they receive
Online Culturally adapted Genetic Counseling InformationExperimentalCulturally developed online Genetic counseling information will be provided. Questionnaires will be administered pre and post genetic counseling intervention as well as 3 months post intervention
Receives: Behavioral: Culturally adapted Online Genetic Counseling and Testing Information

What is being measured

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

  1. Uptake of genetic counseling and genetic testing

    One item question will ask whether participants have participated in genetic counseling and genetic testing (Yes or No)

    Measured: 3 month follow Up

Secondary outcomes (15)
  1. Intention to undergo genetic counseling and testing

    This 2-item measure assesses participant's intentions to undergo genetic counseling and testing (Yes or No)

    Measured: 1 day Pre Intervention to 1 day Post Intervention

  2. Sharing Your Results

    This author-developed 3-item measure assesses the extent to which participants shared information from (1) the video, (2) their counseling appointment, or (3) their testing results with their family. Each item is scored individually as binary (Yes or No) with yes=sharing and no=did not share.

    Measured: 3 month follow up

  3. Major Experiences of Discrimination

    This 18-item measure assesses whether participants have had 9 major experiences of discrimination (e.g., getting employment, housing, medical care) happen to them (responses: 1=once, 2=2-3 times, 3=4+ times, or 0=never happened). Responses (range 0-27) are summed into an Experiences score with higher score = greater experiences of racism. If participants who respond (1, 2, 3), for any item, they are asked to report the last time this happened (1=past week, 2=past month, 3=past year, 4=more than a year ago). These responses are averaged to create a Frequency score (range 1-4), which is multiplied by the Experiences scores to obtain a Severity score (range 9-108) with higher scores = higher severity of major experiences of discrimination experiences. The Experiences and Severity scores will be assessed as moderators of change in the primary outcomes.

    Measured: 1 day prior to intervention

  4. Everyday Experiences of Discrimination

    This 5-item scale measure assesses experience of discrimination that participants might experience on daily basis (e.g., poor service in a restaurant, getting harassed). Responses are (1=almost everyday, 2=at least once a week, 3=a few times a month, 4=a few times a year, 5=less than once a year, 6=never). Responses (range 5-30) are summed, and all items are when reverse scored, higher scores = greater experiences of everyday discrimination. This measure will be assessed as a moderator of change in the primary outcomes.

    For item with a score of 1-4, participants are asked to name the main reason for the discrimination (examples: ancestry or national origin, gender, race, age, religion, weight). This item is described qualitatively.

    Measured: 1 day prior to intervention

  5. Interpersonal Processes of Care Survey

    This 13-item scale is designed to measure race-specific perceptions of communication between patient and healthcare providers (e.g., compassion, discrimination, and disrespectful office space). Responses are (1=never, 2=rarely, 3=sometimes, 4=usually, 5=always). The first 9 items (mean range 1-5) with higher scores=higher levels of compassion and (reverse scored) lower discrimination. The next 4 items (mean range 1-5) with higher scores=higher disrespectful attitudes from office staff. The two subscales will be assessed as moderators of change in the primary outcomes

    Measured: 1 day prior to intervention

  6. Group-Based Medical Mistrust Scale

    This 12-item scale was developed to measure race-based medical mistrust: the suspicion of mainstream health care systems and professionals and the treatment provided to individuals because they are African American. The items are scored with responses (1=strongly disagree, 2=disagree, 3=neither agree or disagree, 4=agree, 5=strongly agree). Higher scores (mean range 1-5)=higher levels of mistrust of providers. This measure will be assessed as a primary outcome of the intervention

    Measured: 1 day prior to intervention

  7. Perceived Access to Health Care Services

    This 13-item, 4-point Likert-style scale was designed to measure perceptions of ability to get care, considering barriers such as cost, availability, and cultural fit. The scale includes items on cost and access to services. The responses are (1=strongly disagree., 2=disagree, 3=agree, 4=strongly agree) with a mean range of 1-4. Higher score=greater participation in cancer screening and a higher family income level.

    Measured: 1 day prior to intervention

  8. Perceived risk of carrying genetic mutation

    This 1-item measure ("How likely do you think it is that you carry a genetic mutation that increases your risk for cancer?") assesses perceived risk of carrying a genetic mutation that increases risk for cancer. The item is scored (1=not at all to 5=extremely likely; range 1-5). Higher scores=higher perceived likelihood of carrying a genetic mutation.

    Measured: 1 day Pre Intervention to 1 day Post Intervention

  9. Attitudes about genetic counseling and testing

    This 8-item scale is designed to measure positive and negative attitudes about the genetic counseling and testing process using the following 8 adjectives: worthwhile, worrying, reassuring, uncomfortable, wise, healthy, unpleasant, and important. Responses are (1=strongly disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, 5=strongly agree). Higher summed scores (range is 8-40)=more positive attitudes.

    Measured: 1 day Pre Intervention to 1 day Post Intervention

  10. Behavioral beliefs about genetic counseling

    This 30-item scale measures genetic counseling-related beliefs and concerns across the following 6 subscales: "pros" of genetic counseling, "cons" of genetic counseling, competing concerns, cultural concerns, logistic concerns, and desire for more information. The responses are (1=strongly disagree, 2=moderately disagree, 3=neither agree nor disagree, 4=moderately agree, 5=strongly agree). Higher scores (range 15-75)=more positive beliefs.

    Measured: 1 day Pre Intervention to 1 day Post Intervention

  11. Perceived norms

    This 10-item measure assesses injunctive and descriptive norms (5 items each) about genetic counseling. Responses are scored on a 5-point Likert scale (1=strongly disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, 5=strongly agree). Higher scores (range 1=25)=stronger perceived norms for each of the subscales ((injunctive norms and descriptive norms, respectively).

    Measured: 1 day Pre Intervention to 1 day Post Intervention

  12. Knowledge of Genetic Counseling

    This 5-item scale is designed to evaluate an individual's basic knowledge of the genetic counseling process (e.g., How much have you read or heard about genetic counseling for: inherited disease? Cancer, in general?). Items are scored (1=very much to 7=not at all). (Reversed) Higher scores (mean range 1-7)=higher knowledge of genetic counseling.

    Measured: 1 day Pre Intervention to 1 day Post Intervention

  13. Perceived self-Efficacy

    This 10-item measure assesses participant's perceived self-efficacy for pursuing genetic counseling if they were interested. Responses are (1=strongly disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, 5=strongly agree). Higher scores (mean range=1-5)=higher self efficacy for pursuing genetic counseling.

    Measured: 1 day Pre Intervention to 1 day Post Intervention

  14. Multidimensional Impact of Cancer Risk Assessment

    This 25-item scale is designed to evaluate participant emotional responses after genetic testing, regardless of result, across 3 subscales (Distress, Uncertainty, and Positive Experiences-reverse scored). The responses are 0=never, 1=rarely, 3=sometimes, 5=often. Total summed score range=0-95. Higher scores=stronger emotional impact of testing results on the individual. The measure will be assessed as part of the intervention outcomes.

    Measured: 3 month Follow Up

  15. Cancer Family Impact

    This 18-item scale is designed to measure the flow of information and communication about cancer in families, thoughts about family norms about cancer prevention, and the effects of cancer on families across 5 subscales (Flow: flow of information about cancer in families; Negative: negative effects of cancer on the family; Positive: positive effects of cancer on the family; Communicate: how families communicate with each other about cancer; and Norm: reaction to family norms about cancer prevention). The responses are (0=strongly disagree, 1=disagree, 2= neither agree or disagree, 3=agree 4= strongly agree). Higher total (range 0-90) summed scores=greater communication about cancer within the family. The measure will be assessed as part of the intervention

    Measured: 3 Month Follow Up

Timeline

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

  1. First posted27 Feb 2026
  2. Study start18 Apr 2026
  3. Primary completionJul 2029 (estimated)
  4. Study completionJul 2029 (estimated)

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
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
85 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07436078
Sponsor's protocol ID
2025-022
Other IDs
1P01CA272239-01A1
Status last verified
Jun 2026
First submitted
11 Feb 2026
Last updated
23 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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