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

NCT07542405 | Not Yet Recruiting DMC

• 4 other identifiers: UMCC 2024.127NCI-2026-02088HUM00265216K01CA255137
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

BRCA1-Related Hereditary Breast and Ovarian Cancer Syndrome; BRCA2-Related Hereditary Breast and Ovarian Cancer Syndrome; Hereditary Neoplastic Syndrome; Lynch Syndrome

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• Completion of cascade testing

  Up to 9 months

• Dissemination of testing results

  Baseline up to 9 months

Study Arms (2)

Probands (Kindred, invite relatives)

EXPERIMENTAL

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: Discussion; Other: Internet-Based Intervention; Other: Survey Administration; Behavioral: Telephone-Based Intervention

Relatives (Kindred)

EXPERIMENTAL

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: Discussion; Other: Internet-Based Intervention; Other: Survey Administration

Interventions

Discussion OTHER

Ancillary studies

Also known as: Discuss

Probands (Kindred, invite relatives); Relatives (Kindred)

Internet-Based Intervention OTHER

Receive access to the Kindred web-based portal

Probands (Kindred, invite relatives); Relatives (Kindred)

Survey Administration OTHER

Ancillary studies

Probands (Kindred, invite relatives); Relatives (Kindred)

Telephone-Based Intervention BEHAVIORAL

Receive check-in calls

Probands (Kindred, invite relatives)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Neoplastic Syndromes, Hereditary; Colorectal Neoplasms, Hereditary Nonpolyposis

Condition Hierarchy (Ancestors)

Neoplasms; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Katrina Ellis, MD

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cacner AnswerLine

CONTACT

1-800-865-1125; CancerAnswerLine@med.umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 21, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)