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Not yet recruiting NCT07542405

A Web-Based Program (Kindred) to Improve the Understanding of Genetic Cancer Risk and Cancer Genetic Testing in African American Families

No phase Interventional BRCA1-Related Hereditary Breast and Ovarian Cancer Syndrome BRCA2-Related Hereditary Breast and Ovarian Cancer Syndrome Hereditary Neoplastic Syndrome Lynch Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Discussion, Internet-Based Intervention, Internet-Based Intervention, Survey Administration.
Who it may be relevant to
Registry conditions: BRCA1-Related Hereditary Breast and Ovarian Cancer Syndrome, BRCA2-Related Hereditary Breast and Ovarian Cancer Syndrome, Hereditary Neoplastic Syndrome, Lynch Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Kindred: Family Centered Approaches to Promoting Cascade Screening for Hereditary Cancer Syndromes Among African Americans

Overview

This clinical trial studies whether a web-based program, Kindred, works to improve the understanding of genetic cancer risk and cancer genetic testing in African American families. Between 5% and 10% of all cancers are caused by genetic changes that are hereditary, which means that they run in families. Some kinds of cancer or a family history of cancer means individuals are more likely to have a genetic change. If a genetic change is identified in a family, other relatives can choose to undergo hereditary cancer genetic testing to better understand their cancer risk. In families where a genetic change is not identified, or results are uncertain, relatives may also benefit from discussing their cancer risk with providers and, in some cases, getting hereditary cancer genetic testing themselves. Research has shown that African Americans are less likely than other racial groups to engage in cancer genetic testing. Kindred is an online tool that provides information so individuals can learn about their cancer genetic test results, how cancer genetic testing can help individuals and families understand their overall cancer risk (and strategies for reducing risk), and ways to talk with each other about cancer risk and health. This may be an effective way to improve the understanding of genetic cancer risk and cancer genetic testing in African American families.

Interventions

  • Other Discussion
    Ancillary studies
  • Other Internet-Based Intervention
    Receive access to the Kindred web-based portal
  • Other Internet-Based Intervention
    Share information and invite relatives
  • Other Survey Administration
    Ancillary studies
  • Behavioral Telephone-Based Intervention
    Receive check-in calls

Primary outcome measures

  • Recruitment rates (Feasibility) [Time frame: Up to 2 years]
  • Retention rates (Feasibility) [Time frame: Up to 2 years]
  • Reasons for enrollment (Feasibility) [Time frame: Up to 2 years]
  • Reasons for ineligibility (Feasibility) [Time frame: Up to 2 years]
  • Reasons for dropout and withdrawal (Feasibility) [Time frame: Up to 2 years]
  • Ease and process of implementing study procedures (Feasibility) [Time frame: Up to 2 years]
Secondary outcome measures (2)
  • Completion of cascade testing [Time frame: Up to 9 months]
  • Dissemination of testing results [Time frame: Baseline up to 9 months]

Eligibility criteria

Inclusion criteria

  • PROBANDS: Evaluation in the past one-year at the Breast and Ovarian Cancer Risk Evaluation Clinic (BOCRE) or Cancer Genetics Clinic, both located at the University of Michigan (U-M) Rogel Cancer Center who are positive for hereditary breast and ovarian cancer syndrome (HBOC) (BRCA1, BRCA2) or Lynch Syndrome (MLH1, MSH2, MSH6, PMS2, EPCAM); indeterminate negative; or variants of uncertain clinical significance (VUS). If more than one biological relative is known to have received an evaluation for and or completed germline testing for cancer risk, the relative who was evaluated the longest time ago to align with the tradition definition of a proband as defined by the National Cancer Institute (NCI), i.e., the first person identified as possibility having a genetic disorder and who may receive counseling or testing
  • PROBANDS: >= 18-years-old
  • PROBANDS: Completed genetic testing for hereditary cancer syndromes, regardless of results
  • PROBANDS: Able to speak and read English
  • PROBANDS: Access to the internet
  • PROBANDS: Identifies as African American or Black (may have additional race or ethnicity identities)
  • RELATIVES: Biological relative of enrolled proband, regardless of testing completion or timing of testing
  • RELATIVES: >= 18 years old
  • RELATIVES: Able to speak and read English
  • RELATIVES: Access to the internet

Exclusion criteria

  • PROBANDS: No evaluation at U-M or other facility, or evaluation was more than one year ago, or received an evaluation more recently than the relative
  • PROBANDS: Under 18-years-old
  • PROBANDS: Did not receive cancer genetic testing
  • PROBANDS: Does not speak or read English
  • PROBANDS: Does not have internet access
  • PROBANDS: Does not identify as African American or Black
  • RELATIVES: Not a biological relative of proband
  • RELATIVES: Under 18-years-old
  • RELATIVES: Does not speak or read English
  • RELATIVES: Does not have internet access

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • University of Michigan Rogel Cancer Center — Ann Arbor

Identifiers

NCT: NCT07542405 · UMCC 2024.127 · NCI-2026-02088 · HUM00265216 · K01CA255137

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗