NCT07436078

Brief 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. 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
37mo left

Started Apr 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Apr 2026Jul 2029

First Submitted

Initial submission to the registry

February 11, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2029

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

3.3 years

First QC Date

February 11, 2026

Last Update Submit

February 21, 2026

Conditions

Outcome Measures

Primary Outcomes (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)

    3 month follow Up

Secondary Outcomes (15)

  • Intention to undergo genetic counseling and testing

    1 day Pre Intervention to 1 day Post Intervention

  • Sharing Your Results

    3 month follow up

  • Major Experiences of Discrimination

    1 day prior to intervention

  • Everyday Experiences of Discrimination

    1 day prior to intervention

  • Interpersonal Processes of Care Survey

    1 day prior to intervention

  • +10 more secondary outcomes

Other Outcomes (11)

  • Age at enrollment (measured in years)

    1 day prior to intervention

  • PROMIS (Patient-Reported Outcomes Measurement Information System) Anxiety Scale

    1 day prior to intervention

  • PROMIS (Patient-Reported Outcomes Measurement Information System) Depression Scale

    1 day prior to intervention

  • +8 more other outcomes

Study Arms (1)

Online Culturally adapted Genetic Counseling Information

EXPERIMENTAL

Culturally 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

Behavioral: Culturally adapted Online Genetic Counseling and Testing Information

Interventions

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

Online Culturally adapted Genetic Counseling Information

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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
  • + close relatives diagnosed with breast or prostate cancer
  • age \<50 AND another primary breast cancer at any age
  • + 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
  • +6 more criteria

You may not qualify if:

  • Previous genetic counseling and/or testing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

RECRUITING

MeSH Terms

Conditions

Prostatic NeoplasmsColorectal Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Felicity WK Harper, Ph.D

    Barbara Ann Karmanos Cancer Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jasminder Phalore, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 11, 2026

First Posted

February 27, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

July 1, 2029

Study Completion (Estimated)

July 1, 2029

Last Updated

February 27, 2026

Record last verified: 2026-02

Locations