Breast Cancer Clinical Trial

Improving Care After Inherited Cancer Testing

Summary

The IMPACT Study seeks to refine and evaluate the effectiveness of interventions on improving guideline-adherent cancer risk management (CRM) and family communication (FC) of genetic test results. These interventions will be delivered to individuals with a documented pathogenic/likely pathogenic (P/LP) variant or variant of uncertain significance (VUS) in an inherited cancer gene.

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Full Description

Through recruitment of a racially, geographically, and socioeconomically diverse sample of patients, we will achieve the following aims:

Evaluate factors associated with access to genetic risk assessment, counseling, and testing services
Conduct a randomized controlled trial to assess the effectiveness of interventions on improving guideline-adherent CRM and FC of genetic test results
Create and pilot an adaptive intervention to tailor resources to promote CRM and FC
Document and compare multiple implementation outcomes across the different interventions to maximize their effectiveness and improve reach to underserved populations

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

English-speaking
Not adopted (i.e., have information about their biological relatives)
Have an email address with access to internet and a computer, tablet, or smartphone
Documented pathogenic/likely pathogenic variant or VUS in an inherited cancer gene that has CRM guidelines listed in the National Comprehensive Cancer Network (NCCN) Genetic/Familial Panel focused on Breast, Ovarian, and Pancreatic or Colorectal cancers
Are non-adherent (i.e., either undertreatment or overtreatment) to at least one of the current NCCN CRM guidelines or if currently adherent, require ongoing cancer screening

Have at least one at-risk adult, living relative who either:

has not been told about the genetic test result (if P/LP variant result) or family history of cancer (if VUS result) by the participant
has not had their own genetic testing if the participant has a pathogenic/likely pathogenic variant

Study is for people with:

Breast Cancer

Estimated Enrollment:

720

Study ID:

NCT04763915

Recruitment Status:

Recruiting

Sponsor:

Vanderbilt-Ingram Cancer Center

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There is 1 Location for this study

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Vanderbilt-Ingram Cancer Center
Nashville Tennessee, 37212, United States More Info
Anne Weidner, MPH
Contact
615-875-2444
Tuya Pal, MD
Principal Investigator

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Study is for people with:

Breast Cancer

Estimated Enrollment:

720

Study ID:

NCT04763915

Recruitment Status:

Recruiting

Sponsor:


Vanderbilt-Ingram Cancer Center

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