Improving Care After Inherited Cancer Testing (NCT04763915) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Improving Care After Inherited Cancer Testing
United States720 participantsStarted 2022-08-05
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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
What they're measuring
1
Change in FC of genetic test results (if P/LP variant result) or family history of cancer (if VUS result)