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| ID | Type | Description | Link |
|---|---|---|---|
| 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 | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Discussion | Other | Ancillary studies |
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| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cacner AnswerLine | Contact | 1-800-865-1125 | CancerAnswerLine@med.umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Katrina Ellis, MD | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Rogel Cancer Center | Ann Arbor | Michigan | 48109 | United States |
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| Internet-Based Intervention | Other | Receive access to the Kindred web-based portal |
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| Internet-Based Intervention | Other | Share information and invite relatives |
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| Survey Administration | Other | Ancillary studies |
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| Telephone-Based Intervention | Behavioral | Receive check-in calls |
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| 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 |
| 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. | Baseline up to 9 months |
| ID | Term |
|---|---|
| D009386 | Neoplastic Syndromes, Hereditary |
| D003123 | Colorectal Neoplasms, Hereditary Nonpolyposis |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D049914 | DNA Repair-Deficiency Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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