BRCA1-Related Hereditary Breast and Ovarian Cancer Syndrome, BRCA2-Related Hereditary Breast and Ovarian Cancer Syndrome, Hereditary Neoplastic Syndrome, Lynch Syndrome
Conditions
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.
Interventions
OTHERDiscussion
Ancillary studies
OTHERInternet-Based Intervention
Receive access to the Kindred web-based portal
OTHERSurvey Administration
Ancillary studies
BEHAVIORALTelephone-Based Intervention
Receive check-in calls
Sponsors
University of Michigan Rogel Cancer Center
National Cancer Institute (NCI)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rates (Feasibility) | 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) | 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) | 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) | 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) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Completion of cascade testing | Up to 9 months | 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. |
| Dissemination of testing results | Baseline up to 9 months | 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. |
Countries
United States
Contacts
CONTACTCacner AnswerLine
PRINCIPAL_INVESTIGATORKatrina Ellis, MD
University of Michigan Rogel Cancer Center
Outcome results
None listed