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

May 18, 2026 updated by: University of Michigan Rogel Cancer Center

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Probands (Kindred, invite relatives)
Probands receive access to the Kindred web-based portal on study consisting of the following sections: Share and Invite, Meaning of Results, Implications of Results, Communication with Family, Dissemination Plan, Looking Ahead, Glossary, FAQ, Resources List, and Public-Facing Website Information. Probands may optionally share information about their test results and invite >= 4 relatives to join the study via the Share and Invite section in the Kindred portal. Probands also receive two check-in calls at 2- and 4- weeks post-baseline.
Other: Survey Administration
Ancillary studies
Other: Discussion
Ancillary studies
Other Names:
  • Discuss
Other: Internet-Based Intervention
Receive access to the Kindred web-based portal
Other: Internet-Based Intervention
Share information and invite relatives
Behavioral: Telephone-Based Intervention
Receive check-in calls
Experimental: Relatives (Kindred)
Invited relatives receive access to the Kindred web-based portal on study consisting of the following sections: Meaning of Results, Implications of Results, Communication with Family, Getting Testing, Looking Ahead, Glossary, FAQ, Resources List, and Public-Facing Website Information.
Other: Survey Administration
Ancillary studies
Other: Discussion
Ancillary studies
Other Names:
  • Discuss
Other: Internet-Based Intervention
Receive access to the Kindred web-based portal
Other: Internet-Based Intervention
Share information and invite relatives

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recruitment rates (Feasibility)
Time Frame: Up to 2 years
Will carefully monitor recruitment (refusals and enrollees, 20% of invited). As this is a single-arm pilot study, no formal hypothesis testing is planned. Qualitative data from focus groups will be conducted using directed content analysis in order to identity key findings and themes to inform intervention content and structure for a future clinical trial.
Up to 2 years
Retention rates (Feasibility)
Time Frame: Up to 2 years
Will carefully monitor retention (75% of enrolled). As this is a single-arm pilot study, no formal hypothesis testing is planned. Qualitative data from focus groups will be conducted using directed content analysis in order to identity key findings and themes to inform intervention content and structure for a future clinical trial.
Up to 2 years
Reasons for enrollment (Feasibility)
Time Frame: Up to 2 years
Will carefully monitor reasons for enrollment. As this is a single-arm pilot study, no formal hypothesis testing is planned. Qualitative data from focus groups will be conducted using directed content analysis in order to identity key findings and themes to inform intervention content and structure for a future clinical trial.
Up to 2 years
Reasons for ineligibility (Feasibility)
Time Frame: Up to 2 years
Will carefully monitor reasons for ineligibility. As this is a single-arm pilot study, no formal hypothesis testing is planned. Qualitative data from focus groups will be conducted using directed content analysis in order to identity key findings and themes to inform intervention content and structure for a future clinical trial.
Up to 2 years
Reasons for dropout and withdrawal (Feasibility)
Time Frame: Up to 2 years
Will carefully monitor reasons for dropout and withdrawal. As this is a single-arm pilot study, no formal hypothesis testing is planned. Qualitative data from focus groups will be conducted using directed content analysis in order to identity key findings and themes to inform intervention content and structure for a future clinical trial.
Up to 2 years
Ease and process of implementing study procedures (Feasibility)
Time Frame: Up to 2 years
Will carefully monitor ease and process of implementing study procedures. As this is a single-arm pilot study, no formal hypothesis testing is planned. Qualitative data from focus groups will be conducted using directed content analysis in order to identity key findings and themes to inform intervention content and structure for a future clinical trial.
Up to 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Dissemination of testing results
Time Frame: Baseline up to 9 months
Will calculate a measure of dissemination of testing results with the following formula: Dissemination = number of biological relatives informed about testing results by probands or relatives/total number of identified 1st, 2nd, 3rd degree relatives of proband. Will collect data from all participants on the number of biological relatives informed of proband's testing results by either the probands or relatives at baseline and follow-up (numerator); will collect this information at baseline recognizing that some information sharing could have occurred before our formal baseline assessment. The total number of identified relatives include 1st, 2nd, 3rd degree relatives of proband (denominator). Will be tabulated and summarized with descriptive statistics.
Baseline up to 9 months
Completion of cascade testing
Time Frame: Up to 9 months
Will be calculated as the percentage of at-risk relatives completing cascade testing as follows: percent of enrolled relatives completing testing = number of at-risk enrolled relatives completing testing/total number of enrolled relatives at risk. Will collect data from enrolled relatives at follow-up, to determine the number of at-risk enrolled relatives who completed testing (numerator). Will collect data from proband clinic records, and proband and relative surveys, to determine the number of enrolled relatives at risk, that is, those for whom further testing is recommended (denominator). Will also examine this outcome by relative degree status (i.e., percent of first-degree enrolled relatives competing testing, etc.). Will be tabulated and summarized with descriptive statistics.
Up to 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Michigan Rogel Cancer Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Katrina Ellis, MD, University of Michigan Rogel Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 14, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 21, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UMCC 2024.127
  • NCI-2026-02088 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • HUM00265216 (Other Identifier: University of Michigan Rogel Cancer Center)
  • K01CA255137 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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