BRCA1-Related Hereditary Breast and Ovarian Cancer SyndromeNCT07542405
A Web-Based Program (Kindred) to Improve the Understanding of Genetic Cancer Risk and Cancer Genetic Testing in African American Families
A study testing Discussion, Internet-Based Intervention and Survey Administration in people with BRCA1-Related Hereditary Breast and Ovarian Cancer Syndrome and BRCA2-Related Hereditary Breast and Ovarian Cancer Syndrome, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- BRCA1-Related Hereditary Breast and Ovarian Cancer Syndrome, BRCA2-Related Hereditary Breast and Ovarian Cancer Syndrome, Hereditary Neoplastic Syndrome
- What is being tested?
- Discussion, Internet-Based Intervention and Survey Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
Katrina Ellis, CancerAnswerLine@med.umich.edu
Katrina Ellis, MD
About this study
Official title: 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.
- Conditions
- BRCA1-Related Hereditary Breast and Ovarian Cancer Syndrome, BRCA2-Related Hereditary Breast and Ovarian Cancer Syndrome, Hereditary Neoplastic Syndrome, Lynch Syndrome
- Being tested
- Discussion, Internet-Based Intervention, Survey Administration, Telephone-Based Intervention
- Medical subject headings
- Neoplastic Syndromes, Hereditary, Colorectal Neoplasms, Hereditary Nonpolyposis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiscussionOther
Also called Discuss
Ancillary studies
Internet-Based InterventionOther
Receive access to the Kindred web-based portal
Internet-Based InterventionOther
Share information and invite relatives
Survey AdministrationOther
Ancillary studies
Telephone-Based InterventionBehavioural
Receive check-in calls
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Discussion; Other: Internet-Based Intervention; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 2 years
Secondary outcomes (2)
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.
Measured: Up to 9 months
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.
Measured: Baseline up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start15 Jun 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BRCA1-Related Hereditary Breast and Ovarian Cancer SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Katrina Ellis, MD, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07542405
- Sponsor's protocol ID
- UMCC 2024.127
- Other IDs
- NCI-2026-02088, HUM00265216, K01CA255137
- Status last verified
- May 2026
- First submitted
- 14 Apr 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kindred: Family Centered Approaches to Promoting Cascade Screening for Hereditary Cancer Syndromes Among African Americans
- ClinicalTrials.gov ID
- NCT07542405
- Acronym / sponsor ID
- UMCC 2024.127
- Conditions
- BRCA1-Related Hereditary Breast and Ovarian Cancer Syndrome, BRCA2-Related Hereditary Breast and Ovarian Cancer Syndrome, Hereditary Neoplastic Syndrome, Lynch Syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probands (Kindred, invite relatives) | Experimental | Other: Discussion, Other: Internet-Based Intervention, Other: Survey Administration, Behavioral: Telephone-Based InterventionProbands 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. |
| Relatives (Kindred) | Experimental | Other: Discussion, Other: Internet-Based Intervention, Other: Survey AdministrationInvited 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiscussionAlso: DiscussAncillary studies | Other | Probands (Kindred, invite relatives), Relatives (Kindred) |
| Internet-Based InterventionReceive access to the Kindred web-based portal | Other | Probands (Kindred, invite relatives), Relatives (Kindred) |
| Internet-Based InterventionShare information and invite relatives | Other | Probands (Kindred, invite relatives) |
| Survey AdministrationAncillary studies | Other | Probands (Kindred, invite relatives), Relatives (Kindred) |
| Telephone-Based InterventionReceive check-in calls | Behavioural | Probands (Kindred, invite relatives) |
Primary outcome
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.
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.
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.
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.
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.
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.
2 secondary outcomes
Completion of cascade testing
Time frame: Up to 9 months
Dissemination of testing results
Time frame: Baseline up to 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katrina Ellis, MD principal investigator
University of Michigan Rogel Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Discussion, Internet-Based Intervention and Survey Administration in people with BRCA1-Related Hereditary Breast and Ovarian Cancer Syndrome and BRCA2-Related Hereditary Breast and Ovarian Cancer Syndrome, run by University of Michigan Rogel Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cacner AnswerLine (1-800-865-1125, CancerAnswerLine@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rates (Feasibility) (time frame: Up to 2 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.