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

N/ANot Yet RecruitingNCT07542405

University of Michigan Rogel Cancer Center150 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

150

Conditions

Interventions

DiscussionOTHER

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 InterventionBEHAVIORAL

Receive check-in calls

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Up to 2 years

Secondary Outcomes

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.

Time frame: 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.

Time frame: Baseline up to 9 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts