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

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: Not yet recruiting
• Conditions: Lynch Syndrome; Hereditary Neoplastic Syndrome; BRCA1-Related Hereditary Breast and Ovarian Cancer Syndrome; BRCA2-Related Hereditary Breast and Ovarian Cancer Syndrome
• Intervention / Treatment: Other: Survey Administration; Other: Discussion; Other: Internet-Based Intervention; Other: Internet-Based Intervention; Behavioral: Telephone-Based Intervention

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cacner AnswerLine; Phone Number: 1-800-865-1125; Email: CancerAnswerLine@med.umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Rogel Cancer Center
      • Contact: Katrina Ellis; Email: CancerAnswerLine@med.umich.edu
      • Principal Investigator: Katrina Ellis, MD

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Recruitment rates (Feasibility)	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)	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)	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)	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)	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)	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

Outcome Measure	Measure Description	Time Frame
Dissemination of testing results	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	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

• Sponsor: University of Michigan Rogel Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Katrina Ellis, MD, University of Michigan Rogel Cancer Center

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: April 14, 2026
• First Submitted That Met QC Criteria: April 14, 2026
• First Posted (Actual): April 21, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Genetic Diseases, Inborn; Metabolic Diseases; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; DNA Repair-Deficiency Disorders; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nutritional and Metabolic Diseases; Colorectal Neoplasms, Hereditary Nonpolyposis; Neoplastic Syndromes, Hereditary
• Other Study ID 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