NCT04763915

Improving Care After Inherited Cancer Testing

Improving Care After Inherited Cancer Testing (IMPACT) Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 720 (estimated)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 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.

Detailed 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.

Conditions

• Inherited Cancer Syndrome
• Prostate Cancer
• Colorectal Cancer
• Endometrial Cancer
• Breast Cancer

Interventions

Type	Name	Description
OTHER	Correlative Studies (Survey)	Administer surveys
OTHER	Correlative Studies (Interview)	In-depth interviews among a subset of participants after the 12-month follow-up survey to either: 1) determine additional resources and tailored message that would be helpful; or 2) assess the adaptive intervention
BEHAVIORAL	GeneSHARE	Access to GeneSHARE, a web-based toolkit which includes interactive and narrative components to enhance FC of genetic test results.
BEHAVIORAL	LivingLabReport	Access to LivingLabReport, 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.
BEHAVIORAL	Standard-of-care & Adaptive Intervention	Receive standard-of-care from their treating healthcare provider. A subset of individuals will also be asked to test and pilot the adaptive intervention, which will consist of tailored resources to promote CRM and FC, after the 12-month follow-up survey.
OTHER	Access to Education Materials	Receive access to VUS educational materials

Timeline

• Start date: 2022-08-05
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2021-02-21
• Last updated: 2025-09-19

Locations

1 site across 1 country: United States