Status:
ACTIVE_NOT_RECRUITING
Improving Care After Inherited Cancer Testing
Lead Sponsor:
Vanderbilt-Ingram Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
University of South Florida
Conditions:
Inherited Cancer Syndrome
Prostate Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
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 ass...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
720 Patients enrolled
Trial Details
Trial ID
NCT04763915
Start Date
August 5 2022
End Date
December 1 2028
Last Update
September 19 2025
Active Locations (1)
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1
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37212