Improving Care after Inherited Cancer Testing (IMPACT) Study

PRIMARY OBJECTIVES:

I. Evaluate factors associated with access to genetic risk assessment, counseling, and testing services.

II. Conduct a randomized controlled trial to assess the effectiveness of interventions on improving guideline-adherent cancer risk management (CRM) and family communication (FC) of genetic test results among individuals with a pathogenic/ likely pathogenic (P/LP) variant in an inherited cancer gene.

III. Conduct a pilot study to assess the effectiveness of an intervention on improving family communication (FC) of family cancer history among individuals with a variant of uncertain significance (VUS) in an inherited cancer gene.

IV. Create and pilot an adaptive intervention to tailor resources to promote CRM and FC.

V. Document and compare multiple implementation outcomes across the different interventions to maximize their effectiveness and improve reach to underserved populations.

OUTLINE: Participants with P/LP randomized to 1 of 3 groups, participants with VUS are assigned to group D.

GROUP A: Participants are provided access to the GeneSHARE toolkit, a web-based toolkit including interactive and narrative components to enhance FC of genetic test results.

GROUP B: Participants are provided access to Living Lab Report, a website containing multiple resources including a summary of the patient’s genetic test results, condition-specific information, recommended CRM, and information on accessing CRM services.

GROUP C: Participants receive standard of care.

GROUP D (VUS PILOT STUDY): Participants are provided access to VUS educational resources including video and written education and assistance for speaking with family members.

After group assignment, participants are followed up at 1, 3, 12, and 18 months.