Improving Care After Inherited Cancer Testing

Overview

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 for individuals with a documented pathogenic/likely pathogenic (P/LP) variant, and FC of family cancer history for individuals with a variant of uncertain significance (VUS) in an inherited cancer gene.

Description

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

1. Evaluate factors associated with access to genetic risk assessment, counseling, and testing services.
2. Conduct a randomized controlled trial to assess the effectiveness of interventions on improving guideline-adherent CRM and FC of genetic test results among individuals with a P/LP variant in an inherited cancer gene.
3. Conduct a pilot study to assess the effectiveness of an intervention on improving FC of family cancer history among individuals with a VUS in an inherited cancer gene.
4. Create and pilot an adaptive intervention to tailor resources to promote CRM and FC.
5. Document and compare multiple implementation outcomes across the different interventions to maximize their effectiveness and improve reach to underserved populations.

Eligibility

Randomized Controlled Trial Eligibility: All trial participants will be autonomous adults

who are capable of participating in the study

Inclusion Criteria:

• English-speaking men and women aged 18 years or older
• Not adopted (i.e., have information about their biological relatives)
• Have access to internet and a computer, tablet, or smartphone
• Documented pathogenic/likely pathogenic variant 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
• Must meet at least one of the following criteria:
  • Intervention A (GeneSHARE) criteria: Have at least one at-risk adult, living relative who either:
    • has not been told about the genetic test result by the participant
    • has not had their own genetic testing
  • Intervention B (LivingLabReport) criteria: 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

        VUS Pilot Study Eligibility: All VUS pilot study participants will be autonomous adults who
        are capable of participating in the study. Eligibility criteria include:
          -  English-speaking men and women aged 18 years or older
          -  Not adopted (i.e., have information about their biological relatives)
          -  Have access to internet and a computer, tablet, or smartphone
          -  Documented VUS in an inherited cancer gene